A Phase 1b/2a, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of AP-PA02 Multi-Phage Therapeutic Candidate for Inhalation in Subjects With Cystic Fibrosis and Chronic Pulmonary Pseudomonas Aeruginosa (Pa) Infection
Phase: PHASE1
Conditions: Cystic Fibrosis, Pseudomonas Aeruginosa, Pseudomonas, Lung Infection, Lung Infection Pseudomonal
Sponsor: Armata Pharmaceuticals, Inc.

Investigational Product: AP-PA-02 
Version Number: 6.0 
Protocol Number: AP-PA02-101 
Version Date: 13 August 2021 
Armata Pharmaceuticals, Inc. 
Page 1 of 115 
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CLINICAL STUDY PROTOCOL COVER PAGE 
A PHASE 1B/2A, MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, 
PLACEBO-CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE STUDY 
TO EVALUATE THE SAFETY AND TOLERABILITY OF AP-PA02 MULTI-
PHAGE THERAPEUTIC CANDIDATE FOR INHALATION IN SUBJECTS WITH 
CYSTIC FIBROSIS AND CHRONIC PULMONARY PSEUDOMONAS 
AERUGINOSA (PA) INFECTION 
Protocol No. AP-PA02-101 
Protocol/Amendment Date: 13 August 2021 
Protocol Version: 6.0 
Supersedes: Version 5.0 
IND Number IND21780 
Sponsor: Armata Pharmaceuticals, Inc. 
Sponsor Address: 
Telephone Number: 
4503 Glencoe Avenue 
Marina del Rey, CA USA 90292 
310-665-2928 x207
Contract Study Medical Monitor: 
Address: 
Phone: 
Mobile: 
Email: 
Michelle Bailey, MD 
Syneos Health 
1030 Sync Street 
Morrisville, NC 28277 
919-745-2723
919-480-4169
Michelle.bailey@syneoshealth.com
CONFIDENTIALITY STATEMENT 
This document contains proprietary and confidential information of Armata 
Pharmaceuticals, Inc. Acceptance of this document constitutes agreement by the recipient 
that no previously unpublished information contained herein will be published or disclosed 
without the prior written approval of Armata Pharmaceuticals, Inc. with the exception that 
this document may be disclosed to study personnel under your supervision who need to 
know the contents for conducting the study and appropriate Institutional Review Boards 
(IRBs)/Ethics Committees (EC) under the condition that the personnel have agreed to keep 
this information confidential. The foregoing shall not apply to disclosure required by 
governmental regulations or laws, however, Armata Pharmaceuticals shall be promptly 
notified of any such disclosure. 

Investigational Product: AP-PA-02 
 
Version Number: 6.0 
Protocol Number: AP-PA02-101 
 
Version Date: 13 August 2021 
 
Armata Pharmaceuticals, Inc. 
 
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INVESTIGATOR SIGNATURE PAGE 
Armata Pharmaceuticals, Inc. 
Protocol No. AP-PA02-101  
Version No. 6.0 
13 August 2021 
 
PRINCIPAL INVESTIGATOR COMMITMENT: 
I will provide copies of the protocol, any subsequent protocol amendments and access to all 
information provided by the Sponsor to the study personnel under my supervision. I will 
discuss this material with them to ensure that they are fully informed about the 
investigational drug and the study protocol. 
I agree to conduct this clinical trial according to the attached protocol, except when mutually 
agreed to in writing. I also agree to conduct this study in compliance with all federal, state 
and local regulations, Good Clinical Practices (GCP), as well as with the requirements of the 
appropriate Institutional Review Board(s) (IRB)/Ethics Committee(s) (EC) and any other 
institutional requirements. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Printed Name of Principal Investigator 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Principal Investigator 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Institution 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Address of Institution 

13Aug2021
115
Investigational Product: AP-PA-02 
Protocol Number: AP-PA02-101 
Version Number: 6.0 
Version Date: 13 August 2021 
PROTOCOL APPROVAL PAGE 
A Phase 1b/2a, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Single 
and Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of AP-PA02 
Multi-Phage Therapeutic Candidate for Inhalation in Subjects with Cystic Fibrosis and 
Chronic Pulmonary Pseudomonas aeruginosa (Pa) Infection 
Sponsor: Armata Pharmaceuticals, Inc. 
Protocol No. AP-PA02-101 
Protocol/ Amendment Date: 13 August 2021 
Protocol Version: 6.0 
The undersigned have reviewed the format and content of this protocol and have approved its 
issuance. 
Name and Title 
Brian Varnum, PhD 
President and Chief Development Officer 
Armata Pharmaceuticals, Inc. 
Dr. Mina Pastagia, MD 
Vice President, Clinical Development 
Armata Pharmaceuticals, Inc. 
Vicki White 
Sr. Director, Clinical Operations 
Armata Pharmaceuticals, Inc. 
Armata Pharmaceuticals, Inc. 
Proprietary and Confidential 
Signature 
Date Signed 
2:t-Jv-
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~/J~ 
0etJV}t()JJ-~ 
f3Aupv1r/ 
Page 3 of 

Investigational Product: AP-PA-02 
 
Version Number: 6.0 
Protocol Number: AP-PA02-101 
 
Version Date: 13 August 2021 
 
Armata Pharmaceuticals, Inc. 
 
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STATEMENT OF COMPLIANCE 
The trial will be conducted in accordance with International Conference on Harmonisation 
Good Clinical Practice (ICH GCP), the Declaration of Helsinki, and applicable United States 
(US) Code of Federal Regulations (CFR). The Principal Investigator will assure that no 
deviation from, or changes to the protocol will take place without prior agreement from the 
Investigational New Drug (IND) sponsor and documented approval from the Institutional 
Review Board (IRB), except where necessary to eliminate an immediate hazard(s) to the trial 
participants. All personnel involved in the conduct of this study have completed Human 
Subjects Protection and ICH GCP Training. 
The protocol, informed consent form(s), recruitment materials, and all participant materials 
will be submitted to the IRB for review and approval. Approval of both the protocol and the 
consent form must be obtained before any participant is enrolled. Any amendment to the 
protocol will require review and approval by the IRB before the changes are implemented to 
the study. All changes to the consent form will be IRB approved; a determination will be 
made regarding whether a new consent needs to be obtained from participants who provided 
consent, using a previously approved consent form. 
 
 

Investigational Product: AP-PA-02 
 
Version Number: 6.0 
Protocol Number: AP-PA02-101 
 
Version Date: 13 August 2021 
 
Armata Pharmaceuticals, Inc. 
 
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1 
SYNOPSIS 
Name of 
Sponsor/Company:  
Armata Pharmaceuticals, Inc. 
Name of 
Investigational 
Product:  
AP-PA02 
Protocol Number: 
AP-PA02-101 
Title of Study: 
A Phase 1b/2a, Multi-Center, Double-Blind, Randomized, Placebo-
Controlled, Single and Multiple Ascending Dose Study to Evaluate 
the Safety and Tolerability of AP-PA02 Multi-Phage Therapeutic 
Candidate for Inhalation in Subjects with Cystic Fibrosis and Chronic 
Pulmonary Pseudomonas aeruginosa (Pa) Infection 
Investigators:  
To be determined 
Study Centers: 
Approximately 30 centers in the United States 
Phase of 
Development: 
1b/2a 
Duration of Subject 
Participation: 
Part 1 Single-Ascending Dose (SAD) Cohorts 1-2: Subjects are on 
study for a total of 29 Days  
Part 2 Multiple-Ascending Dose (MAD) Cohorts 3-4: Subjects are on 
study for a total of approximately 33 days for Cohort 3, and 
approximately 38 days for Cohort 4  
Number of Subjects 
(planned):  
Total of approximately 32 subjects 
8 subjects in Part 1 SAD Cohorts: Two dose cohorts, 4 subjects per 
dose cohort (randomized 3:1, AP-PA02 vs. placebo) 
24 subjects in Part 2 MAD Cohorts: Two dose cohorts, 4 subjects in 
Cohort 3, and 20 subjects in Cohort 4 (randomized 3:1, AP-PA02 vs. 
placebo) 
Objectives: 
Part 1: Single Ascending Dose (SAD) Evaluation 
Primary:  
Evaluate the safety and tolerability of a single dose of AP-PA02 
administered via inhalation. 
Exploratory:  
Examine phage distribution and clearance, evidence of clinical 
efficacy, and the impact of phage therapy on the bacterial target after 
a single dose of AP-PA02 administered via inhalation. 
Part 2: Multiple Ascending Dose (MAD) Evaluation 
Primary: 

Investigational Product: AP-PA-02 
 
Version Number: 6.0 
Protocol Number: AP-PA02-101 
 
Version Date: 13 August 2021 
 
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Evaluate the safety and tolerability of multiple doses of AP-PA02 
administered via inhalation. 
Secondary:  
Explore P. aeruginosa recovery in sputum following multiple doses 
of AP PA02 administered via inhalation.  
Exploratory: 
Examine phage distribution and clearance, evidence of clinical 
efficacy, and the impact of phage therapy on the bacterial target 
following multiple doses of AP-PA02 administered via inhalation. 
Study Design: 
This is a Phase 1b/2a, double-blind, randomized, placebo-controlled, 
single and multiple ascending dose study to evaluate the safety, 
tolerability and phage recovery profile of AP-PA02 administered by 
inhalation.  
 
Figure 1: Cohort Progression Schematic 
 
Figure 2: Enrollment by Cohort Schematic 
 
 
Cohort 1 
~ Safety 
/? Review 
I SAD I 
¾._ Cohort 2 ~ Safety 
e._ 
# 
Review 
¾._ Cohort 3 ~ Safety 
e._ 
,# Review 
Total Enrolled 
n- 32 
SAD Cohortl 
Active n- 3 
Placebon- 1 
lElOTotal phage/dose 
SafetyReview > 
______ ..., _____ _ 
SAD Cohort2 
Active n- 3 
Placebon- 1 
3E10 Total phage/dose 
SafetyReview >---------------
MADCohort3 
Active n- 3 
Placebon- 1 
5.75E10Total phage/dose bid x 5 days 
SafetyReview >-______ ....., ______ _ 
MADCohort4 
Active n- 15 
Placebon- 5 
1.5Ell Total phage/dose bid x 10 days 
► Cohort 4 ) 

Investigational Product: AP-PA-02 
 
Version Number: 6.0 
Protocol Number: AP-PA02-101 
 
Version Date: 13 August 2021 
 
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Part 1: Single Ascending Dose Evaluation 
Part 1 will evaluate single doses of AP-PA02 administered by 
inhalation in medically stable cystic fibrosis patients with chronic 
pulmonary P. aeruginosa infection at time of Screening. A total of 
8 subjects, 4 subjects in each of 2 sequential dose cohorts, will be 
randomized to receive either AP-PA02 or placebo administered via 
inhalation at the clinical site. Each cohort of 4 patients will be 
randomized with 3 subjects to receive active treatment and 1 subject 
to receive placebo.  
Eligible subjects will be randomized to receive a single dose of 
AP-PA02 (or placebo), administered on Day 1. Subjects will be 
followed for safety for approximately 4 weeks post-dose. The first 
two subjects of the same dose cohort will not be permitted to dose on 
the same day to allow for adequate safety monitoring between 
subjects.  
Following dosing, subjects will be closely monitored for safety, 
including repeated measurements of vital signs (blood pressure, heart 
rate, respiratory rate and body temperature) and SpO2 (at 10, 30 and 
60 minutes, and 2, 4 and 7 hours post dose), 12-lead ECG (at 60 
minutes post dose) and spirometry (at 30 minutes, 60 minutes and 
7 hours post dose), and vitals, SpO2 and spirometry are repeated at 24 
and 48 hours post dose as outlined in Appendix 1 Schedule of 
Assessments. 
 
Part 1 SAD Cohort Safety Monitoring:  
Following the completion of each SAD dose cohort, a Safety 
Monitoring Committee (SMC) will review all available safety data 
through Day 8. Initiation of dosing for the next cohort will be 
determined by the SMC based on an adequate safety profile 
demonstrated in the prior cohort.  
If subjects experience any acute AEs post-dose administration 
(regardless of causal relationship to study drug) that have not resolved 
by the time the subject is to be discharged home on Day 1, it will be 
left up to the discretion of the Investigator to admit the subject 
overnight for continued observation, if in the best interest of the 
subject. 
All patients will be followed for 29 days for safety and phage 
recovery profile, or until resolution of study drug or study-related 
AEs. 
If AEs of interest occur at a Grade 3 level or higher in two or more 
subjects in a cohort, then an additional 4 subjects (3 active, 1 placebo) 
may be added to the cohort.  
 
 

Investigational Product: AP-PA-02 
 
Version Number: 6.0 
Protocol Number: AP-PA02-101 
 
Version Date: 13 August 2021 
 
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Part 2: Multiple Ascending Dose (MAD) Evaluation: 
The MAD portion of the study will also be double-blinded, 
randomized, placebo-controlled, to evaluate the safety and efficacy of 
two dose levels of AP-PA02. The first MAD cohort (Cohort 3) will 
enroll 4 subjects, where 3 subjects will be randomized to active 
treatment and 1 subject randomized to receive placebo. The second 
MAD cohort (Cohort 4) will enroll 20 subjects, where 15 subjects 
will be randomized to receive active treatment, and 5 subjects will be 
randomized to receive placebo. The total number of placebo patients 
will be 6 subjects across the two dose cohorts.  
For subjects on a usual regimen of inhaled antipseudomonal 
antibiotics, Day 1 will need to be scheduled relative to the subject’s 
inhaled antibiotic(s) cycle. Subjects will be followed for safety for 
approximately 4 weeks post-last dose. 
Once enrolled, each subject in Cohorts 3 and 4 will receive one 
fractionated dose of AP-PA02 or placebo (one dose distributed over 
two administrations in the same day), for five or ten consecutive days 
in the clinic, respectively. Following each dose, subjects will be 
closely monitored for safety, including repeated measurements of 
vital signs (blood pressure, heart rate, respiratory rate and body 
temperature) and SpO2, 12-lead ECG (at 60 minutes post first dose) 
and spirometry, as outlined in Appendix 1 Schedule of Assessments. 
For Cohort 3, subjects will return to the clinic approximately 24 hours 
post-last dose for safety evaluations and phage titer sampling, for 
Visits 6 through 8, and End of Study Visit. For Cohort 4, subjects will 
return to the clinic approximately 24 hours post-last dose for safety 
evaluations and phage titer sampling, and on Visits 11 through 13, 
and End of Study Visit. Additional follow-up visits for safety and 
anti-drug antibody (ADA) titer will be performed at approximately 
14 days post-last dose and at the End of Study Visit. Follow-up 12-
lead ECG will also be performed at the End of Study Visit. 
The first two randomized subjects of each MAD dose cohort will not 
be permitted to initiate dosing (Day 1) on the same day, to allow for 
adequate safety review.  
 
Part 2 MAD Cohort Safety Monitoring: 
Initiation of enrollment into Part 2 of this study will be dependent on 
the positive recommendation and concurrence of the Sponsor 
following the SMC safety review following Cohort 2, per Figures 1 
and 2 above. 
 
Following the completion of dosing of MAD cohort 3, the SMC will 
review all available safety data through Visit 7 (including any 
additional safety data from the SAD cohorts collected to date), before 
enrollment can continue into Cohort 4.  

Investigational Product: AP-PA-02 
 
Version Number: 6.0 
Protocol Number: AP-PA02-101 
 
Version Date: 13 August 2021 
 
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If subjects experience any acute AEs post-dose administration 
(regardless of causal relationship to study drug) that have not resolved 
by the time the subject is to be discharged home on a given dosing 
day, it will be left up to the discretion of the Investigator to admit the 
subject overnight for continued observation, if in the best interest of 
the subject, and subsequent doses may be delayed or held, with 
concurrence from Study Medical Monitor and/or Sponsor designee. 
All patients will be followed through End of Study Visit for safety 
and efficacy, or until resolution or stabilization of study drug or 
study-related AEs. 
Diagnosis and Main 
Criteria for 
Eligibility:  
Patients who meet the following inclusion criteria and none of the 
exclusion criteria will be considered eligible for enrollment in the 
study.  
Inclusion Criteria: 
 
1. Able and willing to comply with the protocol and provide written 
consent prior to any study-specific procedures. 
2. Male or female ≥ 18 years old. 
3. Body mass index (BMI) of ≥ 18 kg/m2  
4. Must have documentation of one of the following criteria:  
a. Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine 
iontophoresis test performed at or prior to Screening -OR- 
b. Known disease-causing mutations in the CFTR gene on each 
chromosome.  
5. Clinically stable with no significant changes in health status 
within the 7 days prior to and including the Screening Visit 
6. Evidence of chronic pulmonary Pa infection. Evidence includes 
one or more of the following: 
a. Microbiological evidence of pulmonary Pa infection within 
the last 24 months 
b. Current utilization of chronic-suppressive inhaled antibiotics 
for Pa  
c. Oral or parenteral anti-pseudomonal therapy administered 
within the last 2 years  
7. Willing to undergo sputum induction procedures at Screening, 
Baseline and at designated time points during the study, and 
willing to provide expectorated sputum samples at all other 
timepoints (for subjects who are able to expectorate). 
8. Must have ≥104 CFU of Pa per gram of induced sputum obtained 
at Screening 
9. Subject’s Pa isolates are susceptible to AP-PA02, based on 
morphotypes obtained from induced sputum obtained at 
Screening. 

Investigational Product: AP-PA-02 
 
Version Number: 6.0 
Protocol Number: AP-PA02-101 
 
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10. For SAD: FEV1 ≥ 60% of predicted normal for age, gender, race 
and height [using Global Lung Function Initiative (GLI) 
standards] at Screening (regardless of the timing of the most 
recent prior administration of short-acting bronchodilator). 
For MAD: FEV1 ≥ 40% of predicted normal for age, gender, race 
and height [using Global Lung Function Initiative (GLI) 
standards] at Screening (regardless of the timing of the most 
recent prior administration of short-acting bronchodilator). 
11. Stable lung function, determined by the Investigator, provided 
that the FEV1 at the Baseline Visit has not decreased by more than 
5% compared to the FEV1 measured at Screening. 
12. Able to reproducibly perform pulmonary function tests 
(spirometry) per ATS/ERS Standards. 
13. For subjects to be enrolled into Part 1 of the protocol (SAD), 
dosing relative to their inhaled antibiotics schedule is not 
restricted; subjects participating in Part 1 SAD may schedule Day 
1 at any time. For subjects to be enrolled into Part 2 of the 
protocol (MAD), if on inhaled antibiotics for chronic suppression 
of P. aeruginosa: 
a. Subjects on a single, chronically-administered inhaled 
antipseudomonal antibiotic, with no interruption of therapy or 
on two or more alternating inhaled antipseudomonal 
antibiotics, must remain on the same regimen from Screening 
through the end of the study. Day 1 can be scheduled at any 
time. 
b. Subjects on a chronically-administered routine of an 
intermittent inhaled antipseudomonal antibiotic (one month 
“on”, one month “off”) must be at least 6 days and not more 
than 17 days into the on- or off-month on Day 1. 
c. Subjects on a chronically-administered routine of inhaled 
antipseudomonal antibiotic, not following a monthly on/off 
inhaled antibiotic schedule may be enrolled provided the 
subject is on the on-cycle of the inhaled antibiotic from the 
Baseline Visit through approximately 14 days after the last 
study drug dose. 
d. Subjects not on chronically-administered inhaled 
antipseudomonal antibiotics may be scheduled for Day 1 at 
any time. 
14. Creatinine clearance > 80 mL/min, as calculated by Cockcroft-
Gault equation based on actual body weight 
15. Ability to comply with study visits and study procedures as 
judged by the investigator  
16. Female subjects of childbearing potential must agree to use a 
highly effective method of birth control (defined as those, alone 
or in combination, that result in a low failure rate [i.e. less than 

Investigational Product: AP-PA-02 
 
Version Number: 6.0 
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1% per year]) from Day 1 through 60 days following the last dose 
of study drug 
17. Male subjects must agree to use barrier contraception (i.e. 
condoms) from Day 1 through 60 days following the last dose of 
study drug 
18. The following criteria relate to acceptable laboratory values at 
Screening.  
a. Hemoglobin > 8 g/dL 
b. WBC < 14,000/µL 
c. Platelet count > 150 x 103/µL 
d. Prothrombin time (PT), International Normalized Ratio (INR) 
and partial thromboplastin time (PTT) within normal limits. 
Subjects with values outside the normal range may be 
permitted if the value is not clinically significant in the 
opinion of the Investigator, with concurrence from the Study 
Medical Monitor and/or Sponsor designee. 
 
Exclusion Criteria:  
 
1. Decrease in body weight within 90 days prior to Screening that is 
considered clinically significant by the Investigator 
2. Abnormal vital signs at Screening: heart rate (hr) > 110 beats per 
minute (bpm) at rest; systolic blood pressure > 160 or 
< 90 mmHg; respiration rate > 24 breaths per minute; and SpO2 
< 92% at rest on room air 
3. Subject history of, or patient-reported family history of, 
prolonged QT syndrome; or a QTc interval > 450 msec (males) or 
> 470 msec (females) using Fridericia’s formula (QTcF) 
4. Use of supplemental oxygen during the day at rest 
5. Serum albumin < 2.5g/dL at Screening 
6. Alanine aminotransferase (ALT) or aspartate aminotransferase 
(AST) values greater than 3X the upper limit of normal (ULN) at 
Screening. 
7. Oral or parenteral antibiotics received within 30 days prior to the 
Baseline Visit for acute pulmonary exacerbation. Inhaled 
antibiotic use for chronic suppression of P. aeruginosa is 
acceptable. 
8. Any infection as determined to be clinically significant in the 
opinion of the Investigator with concurrence from the Sponsor’s 
Medical Monitor and/or designee that results in receiving new 
systemic antimicrobial therapy within 30 days prior to the 
Baseline Visit. 
9. Currently receiving anti-pseudomonal antibiotic treatment for 
acute sinusitis. 
10. Currently receiving systemic corticosteroids at a dose greater than 
the equivalent of 10 mg/day of prednisone  

Investigational Product: AP-PA-02 
 
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11. Currently receiving treatment for active infection with 
nontuberculous mycobacteria (NTM), Staphylococcus aureus, or 
Burkholderia cepacia complex lung infection. 
12. Currently receiving treatment for aspergillosis or ABPA (allergic 
bronchopulmonary aspergillosis). 
13. Subject initiated on a CFTR potentiator/corrector therapy, such as 
Trikafta®, less than 90 days prior to Screening.  
14. Acquired or primary immunodeficiency syndromes 
15. Active pulmonary malignancy (primary or metastatic) or any 
malignancy requiring chemotherapy or radiation therapy within 
one year prior to screening or anticipated during the study period 
16. History of lung transplantation 
17. Hemoptysis of greater than 30 mLs (cumulative) within 90 days 
prior to Day 1 or hospitalization for hemoptysis within 6 months 
of Day 1 
18. Female pregnant or breastfeeding 
19. Use of any investigational device or administration of any 
investigational products within 8 weeks or five therapeutic 
half-lives prior to study Day 1, whichever is longer. 
20. Smoking more than 10 cigarettes or 2 cigars or 2 pipes per day, or 
nicotine equivalent from vaping, from within 3 months prior to 
screening through the end of the study. 
21. Presence or medical history of clinically significant condition 
which precludes study participation or prevents determination of 
outcome measures. 
22. Any severe, acute, or chronic medical or psychiatric condition, 
laboratory abnormality, or condition other than CF that, in the 
opinion of the Investigator, participation in the study is not in the 
best interest of the patient, puts the subject at undue risk, 
interferes with the results of the study, or makes the subject 
otherwise unsuitable for study participation. 
23. Prior participation in study AP-PA02-101. Subjects previously 
enrolled in this study and received at least one dose of study drug 
are ineligible for re-enrollment. 
Test Product, 
Dosage and Mode 
of Administration: 
AP-PA02 is a proprietary multi-phage therapeutic candidate. Each of 
the bacteriophage drug products (DPs) comprising AP-PA02 will be 
supplied in glass vials as a sterile, single-use (non-preserved) 
solution, to be combined at the clinical site prior to administration to 
the subject. AP-PA02 will be administered in the clinic using PARI 
eflow® investigational electronic nebulizer. 
The SAD cohorts will test a combination of 3 bacteriophage DPs, and 
the MAD cohorts will test a combination of 5 bacteriophage DPs. 
The AP-PA02 dose administered to each subject will be determined 
based on cohort assignment. Dosage (in estimated plaque-forming 
units, or PFUs) per cohort shown below. 

Investigational Product: AP-PA-02 
 
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Cohort 
Each Dose 
(estimated 
PFUs) 
Total Daily 
Dose 
(estimated 
PFUs) 
Total Dose 
Per Treatment 
Course 
(estimated PFUs) 
1 (single dose) 
1E10 
 
 
2 (single dose) 
3E10 
 
 
3 (BID x 5 days) 
5.75E10 
1.15E11 
5.75E11 
4 (BID x 10 days) 
1.5E11 
3E11 
3E12 
Duration of 
Treatment: 
SAD cohorts 1 and 2: One day. 
MAD cohorts 3 and 4:  
Cohort 3: Two fractionated doses administered on five consecutive 
days 
Cohort 4: Two fractionated doses administered on ten consecutive 
days 
Reference Therapy, 
Dosage and Mode 
of Administration:  
Placebo is dilution buffer, comprised of 132 mM NaCl, 1 mM CaCl2 
dihydrate, 10 mM MgCl2 hexahydrate, 10 mM Tris Base, sterile 
water for injection solution with pH 7.4 adjusted with HCl, supplied 
in glass vials.  
Placebo will be administered in the clinic using PARI eflow® 
investigational electronic nebulizer.  
Criteria for 
Evaluation: 
 
Safety and 
Tolerability: 
Safety will be assessed by monitoring AEs, vital signs, laboratory 
data (chemistries, hematology and urinalysis), immunogenicity 
evaluation, electrocardiograms (ECGs), pulmonary function, and 
physical examinations.  
Phage Recovery: Phage recovery of AP-PA02 will be based on AP-PA02 levels as 
measured in sputum and venous blood samples at time points 
specified in the Schedule of Procedures. 
Efficacy: Sputum Pa density as measured in sputum samples at time points 
specified in the Schedule of Procedures. 
Exploratory: The following will be performed or collected for exploratory 
evaluation and analysis: 
• Determine anti-pseudomonas antibiotic sensitivity of Pa isolates 
at specified time points during the study 
• Change from baseline of in vitro sensitivity of subject Pa isolates 
to AP-PA02 and/or individual phage components 
• Cystic Fibrosis Questionnaire-Revised Respiratory Symptom 
Scale score (CFQ-R RSS) 

Investigational Product: AP-PA-02 
 
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• Cystic Fibrosis Respiratory Symptom Diary (CFRSD) and 
Chronic Respiratory Infection Symptom Score (CRISS) 
Statistical Methods: Descriptive statistics will be calculated for all endpoints. 
 
 
 
 

Investigational Product: AP-PA-02 
 
Version Number: 6.0 
Protocol Number: AP-PA02-101 
 
Version Date: 13 August 2021 
 
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TABLE OF CONTENTS 
CLINICAL STUDY PROTOCOL COVER PAGE ..................................................................1 
INVESTIGATOR SIGNATURE PAGE ...................................................................................2 
PROTOCOL APPROVAL PAGE .............................................................................................3 
STATEMENT OF COMPLIANCE ...........................................................................................4 
1 
SYNOPSIS ...............................................................................................................5 
2 
INTRODUCTION .................................................................................................25 
2.1 
Cystic Fibrosis .................................................................................................25 
2.2 
Chronic Pa Lower Respiratory Tract Infection is a Major Cause of 
Morbidity and Mortality in CF ........................................................................25 
2.3 
Phage as Antimicrobials ..................................................................................25 
2.3.1 
Mechanism of Action ...........................................................................26 
2.3.2 
Clinical Candidate AP-PA02 ...............................................................27 
2.4 
Background ......................................................................................................28 
2.4.1 
Pharmacology ......................................................................................28 
2.4.2 
Clinical Experience ..............................................................................30 
2.4.3 
Armata’s Experience with Phage Therapy for Pseudomonas 
aeruginosa ............................................................................................30 
2.5 
Study Rationale ................................................................................................30 
2.5.1 
Clinical Development Strategy ............................................................30 
2.5.2 
Dose Selection Rationale .....................................................................31 
2.5.3 
Proposed Doses ....................................................................................32 
3 
INVESTIGATIONAL MEDICINAL PRODUCT AND NEBULIZER ...............34 
3.1 
Investigational Medicinal Product ...................................................................34 
3.1.1 
Drug Products ......................................................................................34 
3.1.2 
Diluent and Placebo .............................................................................35 
3.1.3 
Packaging and Labeling .......................................................................36 
3.1.4 
Drug Shipment and Storage .................................................................36 
3.1.5 
Dose Preparation ..................................................................................36 
3.1.6 
Dose Administration ............................................................................37 
3.1.7 
Drug Accountability and Reconciliation .............................................37 
3.1.8 
Overdose ..............................................................................................37 
3.2 
Nebulizer ..........................................................................................................37 
3.2.1 
eFlow Nebulizer System ......................................................................37 
4 
STUDY OBJECTIVES AND ENDPOINTS .........................................................39 
4.1 
Part 1 (SAD) ....................................................................................................39 

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4.1.1 
Primary Objective (SAD) ....................................................................39 
4.1.2 
Primary Endpoint (SAD) .....................................................................39 
4.1.3 
Exploratory Objectives (SAD) .............................................................39 
4.1.4 
Exploratory Endpoints (SAD)..............................................................39 
4.2 
Part 2 (MAD) ...................................................................................................40 
4.2.1 
Primary Objective (MAD) ...................................................................40 
4.2.2 
Primary Endpoint (MAD) ....................................................................40 
4.2.3 
Secondary Objective (MAD) ...............................................................40 
4.2.4 
Secondary Endpoint (MAD) ................................................................40 
4.2.5 
Exploratory Objectives (MAD) ...........................................................40 
4.2.6 
Exploratory Endpoints (MAD) ............................................................40 
4.3 
Criteria for Evaluation .....................................................................................41 
4.3.1 
Safety and Tolerability .........................................................................41 
4.3.2 
Efficacy ................................................................................................41 
4.3.3 
Phage Recovery ...................................................................................41 
4.3.4 
Exploratory ..........................................................................................41 
5 
STUDY DESIGN...................................................................................................42 
5.1 
Ascending Dose Evaluations ...........................................................................42 
5.1.1 
Part 1: Single Ascending Dose (SAD) Evaluation ..............................42 
5.1.2 
Part 2: Multiple Ascending Dose (MAD) Evaluation ..........................43 
5.2 
Dose Escalation ................................................................................................44 
5.3 
Dose Escalation Rules......................................................................................45 
5.3.1 
Adverse Events of Interest ...................................................................45 
5.3.2 
Definition of Dose-Limiting Toxicity (DLT) ......................................45 
5.3.3 
Dose Escalation Rules for SAD ...........................................................46 
5.3.4 
Dose Escalation Rules for MAD ..........................................................46 
5.3.5 
Criteria for Study Drug Discontinuation..............................................46 
5.3.6 
Stopping Rules .....................................................................................46 
5.4 
Study Completion and Discontinuation Criteria ..............................................48 
5.4.1 
Study Completion ................................................................................48 
5.4.2 
Study Withdrawal ................................................................................48 
5.4.3 
Study Termination ...............................................................................48 
6 
STUDY POPULATION ........................................................................................50 
6.1 
Selection of Subjects ........................................................................................50 
6.1.1 
Inclusion Criteria .................................................................................50 
6.1.2 
Exclusion Criteria ................................................................................52 
7 
CONCOMITANT MEDICATIONS AND ANCILLARY THERAPY ................54 
7.1 
Inhaled Antipseudomonal Antibiotics .............................................................54 

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7.1.1 
Part 1 SAD Subject Scheduling ...........................................................54 
7.1.2 
Part 2 MAD Subject Scheduling ..........................................................54 
7.2 
Chest Physiotherapy.........................................................................................54 
7.3 
Order of Therapies ...........................................................................................55 
7.4 
CFTR Potentiators/Correctors .........................................................................55 
7.5 
Ancillary Therapy ............................................................................................55 
7.5.1 
Premedication ......................................................................................55 
7.5.2 
Prohibited Concomitant Medications ..................................................55 
7.6 
Adequate Forms of Birth Control ....................................................................55 
7.7 
Adverse Reaction Management .......................................................................56 
8 
EVALUATIONS BY VISIT..................................................................................57 
8.1 
Visit and Assessment Windows .......................................................................57 
8.2 
Screening Visit (All Cohorts) ..........................................................................57 
8.3 
Baseline Visit (All Cohorts).............................................................................58 
9 
STUDY PROCEDURES .......................................................................................59 
9.1 
Vital Signs ........................................................................................................59 
9.2 
Oximetry ..........................................................................................................60 
9.3 
Local Laboratory Evaluations ..........................................................................60 
9.3.1 
Serum Chemistry .................................................................................61 
9.3.2 
Hematology ..........................................................................................61 
9.3.3 
Coagulation ..........................................................................................61 
9.3.4 
Urine Testing .......................................................................................61 
9.4 
Central Laboratory Evaluations .......................................................................62 
9.4.1 
Serology ...............................................................................................62 
9.4.2 
Sputum Microbiology ..........................................................................62 
9.4.3 
Phage Recovery Evaluations ................................................................63 
9.5 
Electrocardiogram (ECG) ................................................................................63 
9.6 
Spirometry........................................................................................................63 
9.7 
Physical Examination.......................................................................................64 
9.8 
Height and Weight ...........................................................................................64 
9.9 
Sweat Chloride and Genotyping ......................................................................64 
9.10 
CFQ-R ..............................................................................................................65 
9.11 
CFRSD-CRISS ................................................................................................65 
10 
SAFETY ASSESSMENTS ....................................................................................66 
10.1 
Safety Monitoring Committee (SMC) .............................................................66 
10.2 
Adverse Events ................................................................................................66 
10.2.1 
Definition .............................................................................................66 
10.3 
Assessment of Adverse Events ........................................................................66 

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10.3.1 
Assessment of the Severity (Intensity) of Adverse Events ..................67 
10.3.2 
Assessment of the Relationship of Adverse Events to Study Drug .....67 
10.3.3 
Assessment of the Outcome of Adverse Events ..................................68 
10.4 
Reporting of Adverse Events ...........................................................................68 
10.4.1 
Adverse Event Reporting Period .........................................................69 
10.4.2 
Eliciting Adverse Events ......................................................................69 
10.4.3 
Recording Adverse and Serious Adverse Events .................................69 
10.5 
Serious Adverse Events ...................................................................................72 
10.5.1 
Definition .............................................................................................72 
10.6 
Suspected Unexpected Serious Adverse Reaction Definition (SUSAR) .........73 
10.7 
Serious Adverse Events Notification ...............................................................73 
10.8 
Expedited Reporting of SUSARs.....................................................................74 
10.9 
Emergency Unblinding Procedure ...................................................................74 
11 
STATISTICAL METHODOLOGY ......................................................................75 
11.1 
General Considerations ....................................................................................75 
11.2 
Determination of Sample Size .........................................................................75 
11.3 
Randomization and Blinding ...........................................................................75 
11.3.1 
Randomization Procedures ..................................................................75 
11.3.2 
Sentinel Subject Precautions ................................................................75 
11.3.3 
Blinding Procedures .............................................................................76 
11.3.4 
Replacement of Subjects ......................................................................76 
12 
ANALYSIS OF POPULATIONS .........................................................................77 
12.1 
Subject Disposition, Demographics and Baseline Disease Characteristics .....77 
12.2 
Treatment Compliance .....................................................................................77 
12.3 
Safety Analyses ................................................................................................78 
12.3.1 
Treatment Emergent Adverse Events ..................................................78 
12.3.2 
Dose-Limiting Toxicities .....................................................................78 
12.3.3 
Vital Signs ............................................................................................78 
12.3.4 
Laboratory Assessments ......................................................................78 
12.3.5 
Immunogenicity ...................................................................................79 
12.3.6 
Other Safety Assessments ....................................................................79 
12.4 
Phage Recovery Analyses ................................................................................79 
12.4.1 
Phage Recovery Measurements ...........................................................79 
12.4.2 
Phage Recovery Analysis Methods .....................................................79 
12.5 
Efficacy Analyses ............................................................................................80 
12.6 
Interim Analysis ...............................................................................................81 
12.7 
Subgroup Analyses ..........................................................................................81 
13 
QUALITY CONTROL AND QUALITY ASSURANCE .....................................82 

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13.1 
Changes to the Protocol ...................................................................................82 
13.2 
Data Collection and Study Monitoring ............................................................82 
14 
ETHICAL AND REGULATORY OBLIGATIONS .............................................84 
14.1 
Ethical Considerations .....................................................................................84 
14.2 
Informed Consent.............................................................................................84 
14.3 
Pre-Study Documentation Requirements .........................................................84 
14.4 
Financial Disclosure .........................................................................................85 
14.5 
Subject Confidentiality ....................................................................................85 
14.6 
Dissemination of Clinical Study Data ..............................................................86 
15 
STUDY ADMINISTRATION ..............................................................................87 
15.1 
Good Clinical Practice and Regulatory Requirements ....................................87 
15.2 
Investigator’s Brochure ....................................................................................87 
15.3 
Protocol Amendments and Study Termination ................................................87 
15.4 
Study Documentation and Storage...................................................................87 
15.5 
Use of Information ...........................................................................................88 
15.6 
End of Trial and Final Report ..........................................................................88 
15.7 
Financing and Insurance ..................................................................................88 
15.8 
Publication Policy ............................................................................................88 
16 
REFERENCES ......................................................................................................89 
17 
APPENDICES .......................................................................................................93 
 
 

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LIST OF APPENDICES 
Appendix 1 
Schedule of Assessments ...........................................................................94 
Appendix 2 
Adult CFQ-R (English) ............................................................................105 
Appendix 3 
CFRSD-CRISS ........................................................................................110 
 
LIST OF TABLES 
Table 1 
Molecular Characteristics of the Individual Bacteriophages in 
AP-PA02 ....................................................................................................28 
Table 2 
AP-PA02 Estimated Dose Levels By Cohort ............................................33 
Table 3 
Composition of AP-PA02 and Diluent/Placebo for Cohorts 3 and 4 ........35 
Table 4 
MAD Dose Exposure .................................................................................44 
Table 5 
Adverse Events of Interest .........................................................................45 
Table 6 
MAD Cohort 3 Vital Signs Timepoints on Dosing Days 1-5 ....................59 
Table 7 
MAD Cohort 4 Vital Signs Timepoints on Dosing Days 1-10 ..................60 
Table 8 
Adverse Event Intensity (Severity) Scale ..................................................67 
 
LIST OF FIGURES 
Figure 1 
Lytic Cycle of Bacteriophages ...................................................................27 
Figure 2 
Cohort Progression Schematic ...................................................................42 
Figure 3 
Enrollment by Cohort Schematic ...............................................................42 

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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
Abbreviation or Term Definition/Explanation 
ABPA 
allergic bronchopulmonary aspergillosis 
ADA 
anti-drug antibody 
ADL 
Activities of Daily Living 
AE 
adverse event 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
ATS/ERS 
American Thoracic Society / European Respiratory Society 
AUC 
Area Under the Curve 
AUC0-∞ 
Area under the curve from time zero to infinity 
AUC0-t 
Area under the curve from time zero to the final time point (last 
quantifiable sample) 
AUC0-τ 
Area under the curve within a dosing interval at Steady-State 
AUClast 
Area under the plasma concentration-time curve from. time zero to 
time of last measurable concentration 
BID 
Twice a day 
BMI 
body mass index 
bpm 
beats per minute; breaths per minute 
BUN 
blood urea nitrogen 
C 
Celsius 
Cavg, ss 
Average Concentration at Steady-State 
Clast 
Last Observed Concentration 
Cmax 
Maximum Concentration 
Cmax, ss 
Maximum Concentration at Steady-State 
Cmin, ss 
Minimum Concentration at Steady-State 
CBC 
complete blood count 
CF 
cystic fibrosis 
CFR 
Code of Federal Regulations 
CFQ-R 
Cystic Fibrosis Questionnaire-Revised 

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Abbreviation or Term Definition/Explanation 
CFRSD 
Cystic Fibrosis Respiratory Symptom Diary 
CFU 
colony-forming units 
CL/F 
Apparent Clearance 
Clinically significant 
An abnormal finding/laboratory value that indicates a new disease 
process, an exacerbation or worsening of an existing condition, or 
requires further action(s) to be taken (e.g. initiation of new therapy). 
CRF, eCRF 
case report form, electronic case report form 
CRISS 
Chronic Respiratory Infection Symptom Score 
CRO 
Contract Research Organization 
CSR 
Clinical Study Report 
dL 
Deciliter 
DLT 
Dose–Limiting Toxicity 
DP 
Drug Product 
DS 
Drug Substance 
EC, IEC 
Ethics Committee, Independent Ethics Committee 
ECG 
electrocardiogram 
eFlow 
The Investigational eFlow® Nebulizer System (PARI Respiratory 
Equipment) 
FDA 
Food and Drug Administration 
FEF25-75 
Forced Expiratory Flow between 25 and 75% of the FVC 
FEV1 
Forced Expiratory Volume in 1 second 
FVC 
Forced Vital Capacity 
g 
Gram 
GCP 
Good Clinical Practice 
GLI 
Global Lung Function Initiative 
HHS 
Health and Human Services 
HR 
heart rate  
ICH 
International Conference on Harmonisation 
IND 
Investigational New Drug 

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Abbreviation or Term Definition/Explanation 
INR 
International Normalized Ratio 
IRB 
Institutional Review Board 
IRT 
Interactive Response Technology 
IUD 
intrauterine device 
IUS 
intrauterine hormone-releasing system 
IV 
Intravenous 
kg 
Kilogram 
L 
Liter 
LABA 
long-acting inhaled β-agonist 
LEC 
Local Ethics Committee 
LLQ 
lower limit of quantification 
LPS 
lipopolysaccharide 
MAD 
Multiple Ascending Dose 
µg 
Microgram 
µL 
Microliter 
MedDRA 
Medical Dictionary for Regulatory Activities 
mEq 
milliequivalent 
mg 
Milligram 
mL 
Milliliter 
mmHg 
millimeters of mercury 
mmol 
Millimole 
MOI 
multiplicity of infection 
Pa, P. aeruginosa 
Pseudomonas aeruginosa 
PFU 
plaque-forming unit 
PT 
prothrombin time, preferred term 
PTT 
partial thromboplastin time 
qs 
quantity sufficient 
QTc 
corrected QT interval 

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Abbreviation or Term Definition/Explanation 
QTcF 
corrected QT interval using Fredericia’s formula 
RR 
respiratory rate 
SABA 
short-acting inhaled β-agonist 
SAD 
Single Ascending Dose 
SAP 
Statistical Analysis Plan 
SAE 
serious adverse event 
SMC 
Safety Monitoring Committee 
SOC 
system organ class, standard of care 
SOP 
Standard Operating Procedure 
SUSAR 
Suspected Unexpected Serious Adverse Reaction 
T½  
terminal half-life 
TEAE 
treatment-emergent adverse event 
TLF 
tables, listings and figures 
Tmax 
Time to maximum concentration (Cmax) 
Tmax, ss 
Time to maximum concentration (Cmax) at Study-State 
ULN 
upper limit of normal 
US 
United States 
 
 

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2 
INTRODUCTION 
Armata Pharmaceuticals, Inc. (Armata, the Sponsor) is developing a proprietary multi-phage 
therapeutic candidate (AP-PA02) for the treatment of Pseudomonas aeruginosa pulmonary 
infections. The intended route of clinical administration is oral inhalation (inhalation) of 
aerosolized AP-PA02. 
2.1 
Cystic Fibrosis 
Cystic fibrosis (CF) is a genetic disease caused by mutations in the cystic fibrosis 
transmembrane conductance regulator (CFTR) gene. CF affects over 30,000 people in the 
United States (US) (approximately 70,000 worldwide) with approximately 1,000 new 
diagnoses per year (Cystic Fibrosis Foundation Patient Registry 2018). Dysfunction of the 
CFTR gene leads to dysfunction in multiple organs (Mall and Hartl 2014), but particularly 
the lungs, where a failure of hydration of airway secretions results in thick mucus, chronic 
inflammation, airway remodeling, and recurrent infections (Pettit and Fellner 2014). Lung 
function continues to decline over time, punctuated by pulmonary exacerbations with 
increased cough, shortness of breath, and infections that result in rapid declines in lung 
function (Parkins et al. 2012). For these reasons, CF remains the most common fatal 
hereditary lung disease (Mall and Hartl 2014).  
2.2 
Chronic Pa Lower Respiratory Tract Infection is a Major Cause of 
Morbidity and Mortality in CF 
Outcomes for people with CF have improved significantly in recent years through early 
screening (Smyth et al. 2014), the development and use of CFTR modulators (Pettit and 
Fellner 2014), and other therapies. Treatment of pulmonary Pa infections using inhaled 
antibiotics is an especially important part of CF disease modulation. Chronic Pa infections in 
CF are associated with worsening lung function, frequent pulmonary exacerbations, and 
increased mortality (Courtney et al. 2007; Kerem et al. 2014; Taccetti et al. 2005). In chronic 
lower respiratory tract Pa infections, the goal of antibiotic therapy is suppression, and a 
majority of patients are on a regimen of either continuous alternating therapy or regular 
intermittent therapy with 28-day cycles of inhaled tobramycin, aztreonam, and/or colistin 
(Nichols et al. 2019) consistent with current guidelines (Smyth et al. 2014; Mogayzel et al. 
2013). With routine use of inhaled antibiotics, many patients with chronic Pa infection have 
improved lung function and less frequent exacerbations (Ramsey et al. 1993; Conway 1999; 
Sawicki et al. 2012; Mayer-Hamblett et al. 2015). However, numerous CF patients still 
experience clinical deterioration despite routine inhaled antibiotics (Nichols et al. 2019), 
hence the need for more effective therapies, ideally with a different mechanism of action 
compared to traditional antibiotics, for the treatment of chronic Pa infection. This 
first-in-human clinical trial will study the safety, tolerability, and efficacy of inhaled 
AP-PA02 phage therapy in subjects with CF and chronic Pa infection.  
2.3 
Phage as Antimicrobials 
Lytic phages are viruses that specifically infect and kill bacteria. There are estimated to be 
more than 1031 bacteriophages (ten million trillion trillion) on Earth. They can be found 

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wherever bacteria exist, such as soil and seawater, extreme environments, wastewater, 
hospitals, and animal and human tissues (Clokie et al. 2011). Phages are completely devoid 
of metabolic activity and depend on bacterial translation machinery to multiply, and have no 
affinity for eukaryotic cells.  
Phages have a number of potential advantages over traditional chemical antibiotics. Phages 
infect both antibiotic-sensitive and -resistant bacteria, and therefore the antimicrobial activity 
of phages is completely independent of antibiotic resistance (Bragg et al. 2014; Chan et al. 
2018; Schooley et al. 2017; Dedrick et al. 2019). The primary advantage of phage activity is 
their extreme specificity towards a bacterial species; this aspect of phage biology suggests 
that fewer adverse effects on the gut microbiome will be seen with phage therapy compared 
with traditional antibiotics, which affect many bacterial species (Dissanayake et al. 2019; 
Cieplak et al. 2018; Denou et al. 2009). Phages also have in vitro efficacy against biofilms, 
where antibiotics are poorly effective (Parasion et al. 2014). Finally, the so-called traits of 
“self-dosing”— amplification at the site of bacterial infection - and “self-limiting” - failure to 
amplify and clearance of phage once bacteria are eliminated - are seen as another significant 
advantage of phage use as antimicrobials.  
The clinical potential of virulent bacteriophage as antibacterial agents was first recognized by 
Felix d’Herelle, one of the pioneers of the phage therapy field, in the early 1900’s 
(d’Herelle 1931; Twort 1936). Phages were discovered in 1915 at the Pasteur Institute and 
were shown to kill bacteria taken from patients suffering from dysentery. Throughout the 
pre-antibiotic era, phages were widely used as a therapeutic agent to combat a variety of 
bacterial infections (Twort 1936). However, phage use was displaced by the common use of 
broad-spectrum antibiotics in the early 1940s, particularly in Western medicine (Kortright et 
al. 2019). The recent development of multi-drug resistant bacterial infections has led to 
reconsideration of alternative antimicrobial therapies such as phage. 
Phage therapy has been widely used in human medicine for the past century up through 
present day (Kutateladze and Adamia 2010). However, the safety and effectiveness of these 
therapies have not been conclusively established due to the lack of randomized, controlled 
clinical studies. 
2.3.1 
Mechanism of Action 
Phages initiate infection by recognizing a specific receptor on the surface of their target 
bacterium, a process known as adsorption (Bertozzi et al. 2016; Barbu et al. 2016) (Figure 1). 
Once bound to its receptor, the phage initiates genome translocation to the cytoplasm, and 
bacterial metabolism is quickly subverted and channeled towards phage replication and 
production of virions (Weigel and Seitz 2006).  
Phage infection culminates with lysis of the infected cell and release of progeny 
(Young 2014). Lysis is triggered by the controlled opening of holes in the cellular membrane 
releasing cell-wall degrading enzymes commonly referred to as lysins (Cahill and Young 
2019). These lysins have intrinsic antimicrobial activities (Van Tassell et al. 2016; 
Abdelkader et al. 2019). While cell lysis is obviously bactericidal, phages possess multiple 
functions, such as preventing the capacity to divide or maintain a normal metabolism, that 

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also effectively kill cells (Bouet et al. 1996). When there are no target bacteria left for the 
phages to infect, they are removed through the body’s natural clearance processes. 
Figure 1 
Lytic Cycle of Bacteriophages  
 
Figure 1. Schematic representation of virulent phage infection, replication and lysis of bacterial host 
cells (Barbu et al., 2016). 
2.3.2 
Clinical Candidate AP-PA02 
AP-PA02 is a proprietary multi-phage therapeutic candidate aimed at treating P. aeruginosa 
infections. The initial formulation (tested in single dose Cohorts 1 and 2) will be comprised 
of three active, lytic P. aeruginosa bacteriophages: ARPA0003, ARPA0022, and 
ARPA0034. The formulation to be tested in multiple dose cohorts 3 and 4 will be comprised 
of the same three bacteriophages as was tested in Cohorts 1 and 2, and will also include two 
additional, lytic P. aeruginosa bacteriophages: ARPA0002 and ARPA0028. Table 1 
summarizes the molecular characteristics of each bacteriophage. 
•••• 
• ••• • • 
lysis of bacterial cell and 
phage progeny release 
.. •·· . .... 
L., \ 
~ .... ?' 
Phage progeny 
assembly 
Virulent phage 
Ille cycle 
Protein synthesis 
and DNA rephcatioo 
Phage binding 10 
acterial host cell 

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Table 1 
Molecular Characteristics of the Individual Bacteriophages in 
AP-PA02 
Phage 
Family 
Genus 
Genome 
Structure 
Genome 
Size (kb) 
No. of 
Encoded 
Proteins 
Manufacturing 
Host 
Host 
Receptor 
Initial 3-phage formulation 
ARPA0003 Myoviridae 
Pbunavirus 
dsDNA 
64 
97 
PAK 
(WH-SGI-V-
07193) 
LPS 
ARPA0022 Myoviridae 
Pbunavirus 
dsDNA 
67 
99 
PAO1 ΔalgD  
(GH-SGI-V-07209) 
LPS 
ARPA0034 Podoviridae Phikmvvirus 
dsDNA 
44 
55 
PAO1 ΔalgC  
(GH-SGI-V-07210) 
Pili 
Phages added for 5-phage formulation 
ARPA0002 Myoviridae Pakpunavirus 
dsDNA 
94 
198 
PAK ΔalgD 
(GH-AR-17604) 
LPS 
ARPA0028 Myoviridae Bruynoghevirus dsDNA 
45 
71 
DCF47 
LPS 
Abbreviations: LPS = Lipopolysaccharide; dsDNA: double-stranded DNA (deoxyribonucleic acid) 
 
Each bacteriophage was isolated from the environment by enrichment on strains of 
P. aeruginosa, amplified by fermentation in vegetable broth on its manufacturing host, and 
purified through multiple processes including tangential-flow-filtration and anion-exchange 
chromatography. The purification processes are robust with good yields resulting in phage 
drug substances (DS) with a high degree of purity as assessed by determination of levels of 
endotoxins, host-cell DNA, and host-cell proteins, each well below target specifications.  
The DPs that comprise AP-PA02 and the placebo are manufactured and released under 
cGMP conditions by Armata Pharmaceuticals, Inc. The intended route of clinical 
administration is oral inhalation of nebulized AP-PA02. 
Refer to Section 3 for additional product information. 
2.4 
Background 
2.4.1 
Pharmacology 
The pharmacological rationale for AP-PA02 is based on a comprehensive series of in vitro 
and in vivo studies which demonstrate the antimicrobial potential of the phage drug 
candidate. The initial version of AP-PA02 (three-phage product consisting of ARPA0034, 
ARPA0003, and ARPA0022) has desirable characteristics such as potency of individual 
phage, breadth of clinical isolate coverage by individual phages and by the three-phage 
product. Adding two new phages, ARPA0002 and ARPA0028, increases the number of 
clinical isolates sensitive to AP-PA02 and the number of isolates sensitive to at least two 
phages. Using plate-based plaquing and liquid assays detailing the killing kinetics of Pa, 
AP-PA02 with five phages has activity against the majority of clinical Pa isolates, infecting 

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nearly 91% of tested strains, which equates to an 11% increase in susceptibility over the 
3-phage cocktail. Additionally, approximately 80% of isolates are infected by two or more of 
the five phages representing a 17% increase over the three-phage product, theoretically 
improving product potency, and offsetting the potential for the development of resistance. 
AP-PA02 selectivity for Pa has been demonstrated by a lack of activity against a panel of 
other organisms, as would be expected for bacteriophage biology. In vitro testing also 
displays activity of AP-PA02 against Pa biofilms. Collectively, the antimicrobial activity 
data illustrate that AP-PA02 is a potent and selective therapeutic candidate against clinical 
CF isolates. 
To assure potential activity is not impaired in the target physiological compartments post-
dosing, AP-PA02 activity was confirmed in relevant biological fluids, namely sputum and 
plasma. Additionally, AP-PA02 does not interfere with current standard-of-care antibiotics 
including tobramycin, aztreonam, colistin, and additional therapies including hypertonic 
saline and the beta agonist Salbutamol. For several CF clinical isolates, synergy between 
AP-PA02 and either tobramycin or aztreonam was observed.  
The potential for the bacteriophage particle to stimulate the immune system through direct 
activation of innate immunity mechanisms or through enhanced stimulation by lysed 
bacterial components was evaluated in vitro with primary human peripheral blood monocytes 
(PBMCs). No direct stimulation was observed with phage alone, and no increase in 
pro-inflammatory cytokines is detected when phage and bacteria are co-cultured with 
PBMCs. The lack of an inflammatory response to AP-PA02 drug product in vitro confirms 
high drug purity and demonstrates the rapid lysis event of Pa by AP-PA02 does not stimulate 
the immune system above that seen with whole bacteria. 
The pharmacokinetics of AP-PA02 were evaluated in vivo to assess the stability, activity and 
distribution of phage. Intranasal administration of AP-AP02 to mice resulted in persistent 
phage concentrations in the lungs with minimal systemic and off target exposure. These are 
desired qualities for a therapeutic to treat P. aeruginosa lung infections and supports the 
rationale of inhalation therapy in humans. Murine models of Pa lung infection were 
established to evaluate the antimicrobial potential of the three-phage product in the lung 
compartment. Models of Pa lung infections show efficacy and provide data to model human 
doses. Efficacy was observed with bacteriophage doses that reach a multiplicity of infection 
(MOI) above 1, with robust protection in the survival model when the MOI of infection of 
phage to the Pa inoculum is approximately 10 or greater. These results guide the phase 1 
dose selections which align with published compassionate use cases. 
Anti-Drug Antibody Assay 
In considering future patient populations and treatment paradigms, another important 
consideration is the potential for the development of ADA against AP-PA02, which could 
impact tolerability or efficacy. This study will also assess ADA development across the 
treated population. 

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A bridge ELISA has been developed for detection of human (ADA) against each of the three 
phages in the product utilized for Cohorts 1 and 2 that meets the sensitivity requirements by 
the Food and Drug Administration (FDA) of at least 100 ng/mL. Using purified antibodies 
specific to each phage to bridge two phage particles together, this assay can be used to detect 
ADAs in human serum at a range of 2-7300 ng/mL. This assay will be utilized to detect ADA 
response in blood samples collected from subjects enrolled into this clinical trial. These data 
will be useful in determining whether ADAs occur after a single dose. Antibodies to the 
additional two phages in the five-phage product to be used in Cohorts 3 and 4 have been 
generated and a bridge ELISA is currently being developed. This will help determine 
whether ADAs are produced following multiple doses, for 5 or 10 days. Assessments will be 
made of titer, isotype, whether the ADAs are neutralizing, and these data will guide future 
concepts of effective treatment regimens. 
2.4.2 
Clinical Experience 
No prior clinical studies have been conducted with AP-PA02. 
2.4.3 
Armata’s Experience with Phage Therapy for Pseudomonas aeruginosa 
The first generation of an anti-Pa phage therapeutic product AP-PA01 was administered 
under compassionate use to treat patients with serious or life-threatening Pa lung infections 
associated with lung transplantation, cystic fibrosis, or ventilator-associated pneumonia and 
empyema have been treated with inhaled or intravenous (IV) routes of administration. One of 
these cases was recently featured in the peer-reviewed journal Infection after IV AP-PA01 
was administered acutely to treat a cystic fibrosis patient who had developed a multidrug-
resistant bacterial Pa infection (Law et al. 2019). Maddocks et al described the treatment of a 
77 year old woman with Pa ventilator-associated pneumonia and empyema with both inhaled 
and IV administration of AP-PA01 in the American Journal of Respiratory and Critical Care 
Medicine (Maddocks et al. 2019).  
Human exposure through compassionate use of AP-PA01 has been helpful in demonstrating 
the promise of phage therapy, however, no conclusions regarding applicable safety and 
tolerability cannot be drawn from the experience with AP-PA01. Leveraging our experiences 
with AP-PA01, AP-PA02 is a new therapeutic candidate composed of five phages 
representing multiple phage families that demonstrates improved clinical isolate coverage 
over AP-PA01. AP-PA02 is the clinical product that will be tested in the first-in-human 
clinical trial described in this protocol to study the safety, tolerability, and efficacy of phage 
therapy in subjects with CF and chronic airway Pa infection.  
2.5 
Study Rationale 
2.5.1 
Clinical Development Strategy 
In this clinical study, the safety and tolerability of AP-PA02 in adults with chronic airway 
Pa infection will be assessed in a single ascending dose/multiple ascending dose SAD/MAD 
clinical trial. This study will provide an initial understanding of the safety profile of inhaled 
AP-PA02 to treat chronic pulmonary Pa infection in subjects with CF. This study will also 

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yield information on the persistence of AP-PA02 in the airway and on the systemic exposure 
following inhalation. These data will help guide dosing regimens for future studies. Potential 
efficacy of AP-PA02 will be assessed through measures of Pa bacterial sputum density, 
FEV1 and patient-reported outcomes. Though not powered for efficacy endpoints, these 
measures, especially Pa sputum density, will also inform dose and schedule for future trials. 
A key hallmark of phage therapy with replication-competent natural phage is the potential for 
an auto-regulated dose that is characterized by propagation of phage until sensitive organisms 
are eliminated. Because of this feature, the proposed dosing in the SAD/MAD is a first step 
towards defining an acute treatment regimen that accomplishes decolonization. Thus, phage 
therapy is envisioned to be an intermittent therapy and not chronic suppressive therapy. 
Given that chronic suppressive antipseudomonal antibiotic therapy is the standard of care 
(SOC), dosing of AP-PA02 will be in addition to SOC. The dose levels and schedule of dose 
in this study are designed to test the hypothesis that sufficient, acute exposure of AP-PA02 
can result in productive bacteriophage infection and functional eradication of Pa. 
In addition to antibiotic SOC, use of CFTR modulator therapy is increasingly common and 
has led to significant improvements in lung function, sweat chloride, numbers of pulmonary 
exacerbations, body mass index, and quality of life for people with CF (Pettit and Fellner, 
2014). While ivacaftor produced rapid decreases in sputum Pa density that were sustained for 
up to a year, sputum Pa density rebounded (Hisert et al, 2017). Therefore, additional 
antimicrobial therapies for patients with chronic pulmonary Pa infection are still needed, 
even in this new era of widespread use of CFTR modulator therapies. 
The study design is modeled after a conservative, traditional single ascending dose study, 
followed by multiple ascending dose cohorts. Sentinel dosing precautious will be followed 
for all cohorts, with a pause for Safety Monitoring Committee review of safety data before 
progressing to the next dosing cohort. 
2.5.2 
Dose Selection Rationale 
For the single dose cohorts, AP-PA02 is composed of three individual phages delivered at 
equivalent doses calculated by PFU. The proposed dose level in the SAD dose Cohort 1 is 
3.3E9 PFUs per phage (1E10 PFUs per dose). The proposed dose level in the SAD dose 
Cohort 2 is 1E10 PFUs per phage (3E10 PFUs per dose). For a more common reference of 
dose level, the AP-PA02 single doses for Cohorts 1 and 2equate to 1.4 µg and 4.3 µg of 
protein, respectively. 
For the multiple dose cohorts, AP-PA02 is composed of five individual phages delivered at 
equivalent doses calculated by PFU. The proposed dose level in the MAD dose Cohort 3 is 
1.15E10 PFUs per phage (5.75E10 PFUs per dose) given twice daily, which is equivalent to 
1.15E11 PFUs per day, for a total of 5.75E11 PFUs over five days of dosing. The proposed 
dose level in the MAD dose Cohort 4 is 3E10 PFUs per phage (1.5E11 PFUs per dose) given 
twice daily, which is equivalent to 3E11 PFUs per day, for a total of 3E12 PFUs over ten 
days of dosing. For a more common reference of dose level, the AP-PA02 multiple doses for 
Cohorts 3 and 4 both equate to 0.07 mg and 0.36 mg of protein, respectively.  

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To understand the potential for amplification to impact exposure we present an upper bound 
estimate of phage amplification based on the observation that AP-PA02 phages amplify 
in vitro with a burst size (number of progeny produced from one infected bacterium) of 
100-150. We anticipate that in vivo amplification will be somewhat less efficient than in vitro 
amplification. Modeling from assumptions of a density of 1E7 Pa per gram of sputum, if a 
total volume of approximately 100 grams of sputum is assumed in the airways of a subject 
with CF, the total lung burden would be 1E9 total organisms (Hisert et al, 2017). If one 
presumes all 1E9 Pa bacteria were infected by the administered dose and an amplification of 
100-150 phage/bacteria occurred, then the final maximal number of phage in the lung would 
be 1E11-1.15E11 PFU, regardless of the input dose since the bacterial numbers are the 
limiting factor. This theoretical maximum exposure generated with amplification is bracketed 
by the range of administered doses we plan to explore in this clinical study. The impact of 
amplification on phage exposures in humans has yet to be shown. Demonstrating phage levels 
and microbiological impact post-dosing are critical parts of this study essential to 
understanding phage exposure and future dosing regimens.
2.5.3 
Proposed Doses 
The combination of prior human exposure of AP-PA01 (predecessor product of AP-PA02) 
and preclinical data support the dosing scheme proposed in the SAD portion of this trial, 
starting at a single dose in Cohort 1 of 3.3E9 PFU per phage (1E10 PFU per dose) and 
escalating to a single dose in Cohort 2 of 1E10 PFU per phage (3E10 PFU per dose) of 
AP-PA02 administered by inhalation. Upon completion of each SAD dose level, the safety 
data will be reviewed by the Safety Monitoring Committee before initiating the next dose 
cohort. The MAD dosing scheme continues the assessment of safety of inhaled AP-PA02 
across a schedule of two fractionated daily doses over 5 days for Cohort 3, and 10 days for 
Cohort 4. CF is a disease for which mucus impaction of airway segments is a prominent 
feature. Hence, intermittent obstruction of subsegmental bronchi and therefore poor regional 
ventilation may occur throughout the day. We hypothesize that dosing with inhaled AP-PA02 
at two timepoints in a day could lead to better overall distribution of phage and improved 
efficacy than via a single administration. In Cohort 3, we will assess the safety of the 5-phage 
cocktail administrated at a similar dose per phage as was tested in Cohort 2.Cohort 3 dosing 
will be 1.15E10 PFU/phage (5.75E10 PFU per dose) administered BID, which equates to a 
total daily dose of 1.15E11 PFU per day, which will be administered for five consecutive 
days. If there are no clinically significant safety findings per SMC review of Cohort 3 
clinical safety data, Cohort 4 will proceed. The total daily dose of phage will increase 
incrementally from Cohort 3’s total daily dose of 1.15E11 PFU per day (5.75E10 PFU per 
dose BID) to Cohort 4’s total daily dose of 3E11 PFU per day (1.5E11 PFU per dose BID), 
administered for ten consecutive days. Subjects will be monitored closely for adverse events 
and safety measures including sentinel dosing, stopping rules for individual subjects and the 
study itself as part of the study conduct. This MAD dosing scheme permits rational 
exploration of safety while increasing the likelihood of reaching an efficacious dosing 
regimen of inhaled AP-PA02, as assessed by microbiological endpoints, that will inform 
dose selection for exploration in further clinical trials.  

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Table 2 
AP-PA02 Estimated Dose Levels By Cohort 
Cohort 
Each Dose 
PFUs  
(protein) 
Daily Dose  
PFUs 
(protein) 
Total Dose Per 
Treatment Course 
PFUs 
(protein) 
1 (single dose) 
1E10 
(1.4µg) 
 
 
2 (single dose) 
3E10 
(4.3 µg) 
 
 
3 (BID x 5 days) 
5.75E10 
(6.9 µg) 
1.15E11 
(13.9 µg) 
5.75E11 
(69.4 µg) 
4 (BID x 10 days) 
1.5E11 
(18.1 µg) 
3E11 
(36.2 µg) 
3E12 
(362.0 µg) 
 
Based on the proposed doses in the MAD dose escalation scheme above, the total PFUs 
administered to the subject for the MAD cohorts 3 and 4 are 5.75E11 and 3E12, respectively, 
which equate to 0.07 mg and 0.36 mg of protein, respectively. 

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3 
INVESTIGATIONAL MEDICINAL PRODUCT AND NEBULIZER 
3.1 
Investigational Medicinal Product 
The investigational medicinal product (IMP), AP-PA02, is comprised of five bacteriophage 
drug products (DPs) which are manufactured by Armata Pharmaceuticals, Inc. (Armata). All 
processes are conducted under cGMP requirements including manufacturing, product 
storage, Quality Control (QC) raw materials, analytical and stability testing, and product 
release by Quality Assurance (QA). Bacterial fermentation, filtration and chromatography are 
performed in ISO 8 certified cleanrooms. Aseptic filling is performed in an ISO 5 certified 
isolator located within an ISO 7 certified cleanroom. QC analytical and stability testing are 
performed in a controlled environment. Where possible, single-use disposable parts (filters, 
tubing, vessels, etc.) are used to reduce the risk of contamination during the manufacturing 
process.  
3.1.1 
Drug Products 
Each of the DPs is supplied as an opalescent to clear solution in a 2-mL clear glass vial 
closed with a sterile stopper and sealed with an aluminum crimped cap.  
For the single dose cohorts, Cohorts 1 and 2, three of the five DPs will be combined for each 
dose (ARPA0003, ARPA0022, AND ARPA0034). Each vial contains 0.8 mLs of 
approximately 3E10 total PFU/mL, 132 mM NaCl, 1 mM CaCl2 dihydrate, 10 mM MgCl2 
hexahydrate, 10 mM Tris Base, sterile water for injection solution with pH 7.4 adjusted with 
HCl.  
For the multiple dose cohorts, Cohorts 3 and 4, all five DPs, formulated at a slightly higher 
concentration as shown below, will be combined for each dose. Each vial contains 0.9 mLs 
of approximately 5E10 total PFU/mL, 132 mM NaCl, 1 mM CaCl2 dihydrate, 10 mM MgCl2 
hexahydrate, 10 mM Tris Base, sterile water for injection solution with pH 7.4 adjusted with 
HCl.  
All five DPs are stable at 2–8°C. 
Table 3 presents the composition of the five DPs as formulated for Cohorts 3 and 4, supplied 
as 5E10 PFU per mL, and the diluent/placebo. 

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Table 3 
Composition of AP-PA02 and Diluent/Placebo for Cohorts 3 and 4 
Component 
ARPA0003 
DP 
ARPA0022 
DP 
ARPA0034 
DP 
ARPA0002 
DP 
ARPA0028 
DP 
Diluent/ 
Placebo 
Phage 
ARPA0003 
(PFU/mL) 
5 × 1010 
0 
0 
0 
0 
0 
Phage 
ARPA0022 
(PFU/mL) 
0 
5 × 1010 
0 
0 
0 
0 
Phage 
ARPA0034 
(PFU/mL) 
0 
0 
5 × 1010 
0 
0 
0 
Phage 
ARPA0002 
(PFU/mL) 
0 
0 
0 
5 × 1010 
0 
0 
Phage 
ARPA0028 
(PFU/mL) 
0 
0 
0 
0 
5 × 1010 
0 
Tris base 
(mg/mL) 
1.2 
1.2 
1.2 
1.2 
1.2 
1.2 
Sodium 
chloride 
(mg/mL) 
7.8 
7.8 
7.8 
7.8 
7.8 
7.8 
Calcium 
chloride 
dihydrate 
(mg/mL) 
0.15 
0.15 
0.15 
0.15 
0.15 
0.15 
Magnesium 
chloride 
hexahydrate 
(mg/mL) 
2.0 
2.0 
2.0 
2.0 
2.0 
2.0 
Hydrochloric 
acid 
q.s. to pH 
7.4 
q.s. to pH 
7.4 
q.s. to pH 
7.4 
q.s. to pH 
7.4 
q.s. to pH 
7.4 
q.s. to pH 
7.4 
Water for 
injection 
qs 
qs 
qs 
qs 
qs 
qs 
Abbreviations: mg = milligram; mL = milliliter; PFU = plaque forming unit; qs = quantity sufficient 
 
3.1.2 
Diluent and Placebo  
Diluent/Placebo for IMP product dilutions is provided in 10 mL clear glass vials closed with 
a sterile stopper and sealed with an aluminum crimped cap. Each diluent vial contains 
132 mM NaCl, 1 mM CaCl2 dihydrate, 10 mM MgCl2 hexahydrate, 10 mM Tris Base, sterile 
water for injection solution with pH 7.4 adjusted with HCl. 

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3.1.3 
Packaging and Labeling 
The bacteriophage DPs comprising AP-PA02 are packaged, labeled and released according 
to cGMP requirements appropriate for investigational products. Primary packaging for 
AP-PA02 is comprised of stoppered, crimped cap vials. The secondary packaging for the 
3-phage configuration is a hard-cardboard box containing the 3 vials (one of each of the 
3 phages), to be used only for the SAD cohorts 1 and 2. The secondary packaging for the 
5-phage configuration for each phage component are cardboard cartons containing 6 vials of 
each phage (one type of phage per carton), to be used only for the MAD cohorts 3 and 4. 
3.1.4 
Drug Shipment and Storage 
An initial supply of DP vials and placebo/diluent vials will be shipped refrigerated (2-8°C) to 
the site investigational pharmacy upon completion of site activation process. Re-supply will 
occur through the central inventory management system. The drug should be stored upright 
and refrigerated in the site pharmacy or a designated locked area at 2-8°C and protected from 
light until use.  
Refer to the Study Manual for additional details on site activation, drug supply and the 
central inventory management system. Refer to the Pharmacy Manual for more detailed 
information regarding study drug receipt, storage, handling, preparation, dispensing and 
destruction. 
3.1.5 
Dose Preparation 
The pharmacist (or other personnel qualified to prepare study drug for administration) at each 
site will receive study drug and will prepare and/or dilute the study drug according to the 
Pharmacy Manual for each administration. Pharmacy staff will be unblinded to subject 
treatment assignment (as assigned by the designated randomization system for the study). All 
other study staff, including the Investigator and subjects, will be blinded to study treatment 
assignment. Appropriate study drug dilutions or placebo will be prepared by an Unblinded 
Study Pharmacist, as detailed in the Pharmacy Manual. The prepared doses will be loaded 
into the nebulizer medication chamber by blinded clinic staff prior to administration to the 
subject. 
Each dose, regardless of total phage (PFUs) per dose, will be prepared as a 3 mL loading 
volume for inhalation via the study nebulizer. The average residual volume left in the 
nebulizer chamber following completion of nebulization of the phage (or placebo) is less 
than 0.1 mL, with an average estimated delivered dose of approximately 97% (by volume) of 
the loading dose. 
The final dose preparations of phage, regardless of total PFUs, as well as placebo, are 
isotonic and pH-neutral.  

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3.1.6 
Dose Administration 
Study drug doses will only be administered by a healthcare professional in an in-clinic 
setting. At-home dose administration will be allowed under supervision of a healthcare 
professional. Subjects will receive study drug by inhalation via the study-designated 
nebulizer. No other nebulizers should be used, and no other medications should be mixed 
with study drug in the study-designated nebulizer medication chamber. 
Each prepared 3 mL dose, regardless of total phage (PFUs) per dose, should take 
approximately 5 minutes for complete nebulization, however, nebulization should continue 
until all DP has been administered. 
3.1.7 
Drug Accountability and Reconciliation 
The Investigator must designate a research pharmacist or other staff member to be unblinded 
and maintain an inventory record of drugs received and dispensed. Used vials should be 
retained for drug accountability by the site monitor, unless prohibited by local procedures, in 
which case an alternative drug accountability process will be agreed upon with the Sponsor. 
Additional details on study drug handling will be provided in the Pharmacy Manual.  
Forms will be provided to facilitate the inventory control. These forms must be used unless 
the Investigator has previously established a system that complies with local regulations and 
is approved by Sponsor. The study drug must be dispensed only at the institution(s) specified 
on form FDA 1572. 
Upon completion or termination of the study and after inventory by a Sponsor-designated 
monitor, it will be determined if unopened drug is to be sent to the Sponsor in the original 
containers or is to be destroyed on site. Residual solutions must be discarded after use, as 
outlined in the Pharmacy Manual and per approved institutional procedures.  
3.1.8 
Overdose  
The effects of overdose of this product are not known. 
3.2 
Nebulizer 
An initial review of the literature indicated that vibrating mesh nebulizers would result in 
significantly less loss of potency (titer) than jet nebulizers (Carrigy et al. 2017). In-house 
testing of jet nebulizers compared to vibrating mesh nebulizers confirmed these results. 
(Refer to the Investigator’s Brochure for additional details.)  
3.2.1 
eFlow Nebulizer System 
The Investigational eFlow® Nebulizer System (PARI Respiratory Equipment) will be used 
to administration. Nebulizer assembly and use will be as described in the Instructions for Use 
(IFU) insert for the Investigational eFlow, as well as the study-specific Study Manual. 

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Study drug dose dilutions prepared by the unblinded pharmacist will be provided to the study 
staff (who are blinded to the treatment assignment) who will load the medication chamber of 
the eFlow nebulizer with the study drug dose specified by randomization. A new nebulizer 
handset will be provided for each subject. For the MAD cohorts, new nebulizer handset will 
be provided for each dose to eliminate the potential variability of cleaning the handset 
between doses for a given subject. 
Study drug will be administered in the clinic by qualified site personnel via the designated 
study nebulizer, until all study drug solution has been administered. Complete administration 
of study drug/placebo, if uninterrupted, should take approximately 5 minutes (a minimal 
amount of study drug solution will remain in the nebulizer medication chamber—this is 
normal). 
The Investigational eFlow used for this study should NOT be used to administer any other 
medication. The study drug for this study should NOT be administered using any other 
nebulizer or eFlow device; only the Investigational eFlow provided for study use. 
 

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4 
STUDY OBJECTIVES AND ENDPOINTS  
4.1 
Part 1 (SAD) 
4.1.1 
Primary Objective (SAD) 
The primary objective of SAD portion of the study is to evaluate the safety and tolerability of 
a single dose of AP-PA02 administered by inhalation. 
4.1.2 
Primary Endpoint (SAD) 
The primary endpoints of Part 1 of the trial are the incidence and severity of 
treatment-emergent adverse events (TEAEs), occurring from Day 1 pre-dose through the End 
of Study (EOS) Visit. 
4.1.3 
Exploratory Objectives (SAD) 
Exploratory objectives of the SAD portion of the study include examining phage distribution 
and clearance, evidence of clinical efficacy, and the impact of phage therapy on the bacterial 
target after a single dose of AP-PA02 administered via inhalation. 
4.1.4 
Exploratory Endpoints (SAD) 
• Phage titer profile in sputum, blood, and urine over time after a single dose of AP-PA02 
administered via inhalation  
• Change in FEV1 (% predicted and absolute volume) from Day 1 pre-dose through EOS 
Visit  
• Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) from Day 1 pre-dose through 
the EOS Visit 
• Changes in the Cystic Fibrosis Respiratory Symptom Diary (CFRSD) and Chronic 
Respiratory Infection Symptom Score (CRISS) from Day 1 pre-dose through the EOS 
Visit  
• Change in P. aeruginosa colony-forming units (CFU) per gram of sputum from Baseline 
through Visit 5 
• Change in P. aeruginosa isolates’ sensitivity to AP-PA02 and/or its individual 
components from Screening through the Visit 5 
• Change in P. aeruginosa isolates’ sensitivity to antipseudomonal antibiotics from 
Baseline through Visit 5 
 

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4.2 
Part 2 (MAD) 
4.2.1 
Primary Objective (MAD) 
The primary objective of the MAD portion of the study is to evaluate the safety and 
tolerability of multiple doses of AP-PA02 administered by inhalation. 
4.2.2 
Primary Endpoint (MAD) 
The primary endpoints of Part 2 of the trial are the incidence and severity of 
treatment-emergent, adverse events (TEAEs), occurring from Day 1 pre-first dose through 
the End of Study Visit. 
4.2.3 
Secondary Objective (MAD) 
The secondary objective is to explore P. aeruginosa recovery in sputum following multiple 
doses of AP-PA02 administered via inhalation.  
4.2.4 
Secondary Endpoint (MAD) 
The secondary endpoint for the MAD portion of the trial is a change in P. aeruginosa 
colony-forming units (CFU) per gram of sputum from the Baseline Visit through 
approximately 14 days after the last dose of study drug. 
4.2.5 
Exploratory Objectives (MAD) 
Additional exploratory objectives of the study include examining phage distribution and 
clearance, evidence of clinical efficacy, and the impact of phage therapy on the bacterial 
target.  
4.2.6 
Exploratory Endpoints (MAD) 
• Phage titer profile in sputum, blood, and urine over time after multiple doses of AP-PA02 
administered via inhalation  
• Change in FEV1 (% predicted and absolute volume) from Day 1 pre-dose through the 
EOS Visit  
• Change in CFQ-R from Day 1 pre-dose through the EOS Visit  
• Changes in the CFRSD and CRISS from Day 1 pre-dose through the EOS Visit  
• Change in P. aeruginosa isolates’ sensitivity to AP-PA02 and/or its individual 
components from Screening through approximately 14 days after the last dose of study 
drug. 
• Change in P. aeruginosa isolates’ sensitivity to antipseudomonal antibiotics from 
Baseline through approximately 14 days after the last dose of study drug.  
 

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4.3 
Criteria for Evaluation 
4.3.1 
Safety and Tolerability 
1. Adverse events (AEs) 
2. Physical examination, including body weight  
3. Vital signs  
4. Electrocardiogram (ECG) 
5. Spirometry (FEV1, FVC and FEF25-75) to evaluate for provoked bronchospasm 
6. Clinical laboratory analyses for indications of toxicity: hepatic, renal 
7. Immunogenicity (ADA) 
 
4.3.2 
Efficacy  
Sputum P. aeruginosa density as measured in sputum samples at time points specified in the 
Schedule of Procedures. 
4.3.3 
Phage Recovery 
Recovery of AP-PA02 will be based on AP-PA02 levels as measured in sputum and venous 
blood samples at time points specified in the Schedule of Procedures. 
4.3.4 
Exploratory 
• Anti-pseudomonas antibiotic sensitivity of Pa isolates at specified time points during the 
study 
• In vitro sensitivity of subject Pa isolates to AP-PA02 and/or individual phage 
components 
• CFQ-R 
• CFRSD-CRISS 

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5 
STUDY DESIGN 
This is a Phase 1b/2a, double-blind, randomized, placebo-controlled, single and multiple 
ascending dose study to evaluate the safety, tolerability and phage titer profile of AP-PA02 
administered by inhalation. Figure 2 and Figure 3 depict the progression of dosing cohorts 
following safety review between cohorts. 
Figure 2 
Cohort Progression Schematic 
 
 
Figure 3 
Enrollment by Cohort Schematic 
 
 
5.1 
Ascending Dose Evaluations 
5.1.1 
Part 1: Single Ascending Dose (SAD) Evaluation 
Part 1 will evaluate single ascending doses of AP-PA02 administered by inhalation in 
medically stable Cystic Fibrosis patients with pulmonary P. aeruginosa infection at time of 
Screening. A total of 8 subjects, 4 subjects in each of two sequential ascending dose cohorts, 
~-C_o_h_o_rt_1~)
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'""'w'----✓)L..) __ c_o_h_o_r_t_4-----J) 
SAD 
L_ __ 
_ 
Total Enrnlled 
n=32 
SAD Cohort! 
Active n=3 
Placebon=l 
lElO Total phage/dose 
SafetyReview > 
______ .._ ____ _ 
SAD Cohort2 
Active n=3 
Placebon=l 
3E10 Total phage/dose 
SafetyReview >-______ .._ _____ _ 
MADCohort3 
Active n=3 
Placebon=l 
5.75E10Total phage/dose bid x 5 days 
SafetyReview >-______ .._ _____ _ 
MADCohort4 
Active n=15 
Placebon=S 
l.SEll Total phage/dose bid x 10 days 
__J 
MAD 

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will be randomized to receive either AP-PA02 or placebo administered via inhalation at the 
clinical site. Each cohort of 4 subjects will be randomized with 3 subjects in the treatment 
group and 1 subject in the placebo group. There will be a total of two placebo subjects 
enrolled across the two dose SAD cohorts.  
Once enrolled, each subject will receive a single dose of AP-PA02 (or placebo) on Day 1. 
Subjects will be followed for safety and phage titer profiles for up to 4 weeks post-dose. The 
first two subjects of the same dose cohort will not be permitted to dose on the same day to 
allow for adequate safety monitoring between subjects. 
The SMC will review all available safety data through Visit 4 for each SAD cohort 
(including any additional safety data from the prior SAD cohorts collected to date), before 
continuing to the next SAD dosing cohort. 
See Section 5.3.3 Dose Escalation Rules for SAD cohorts. 
5.1.2 
Part 2: Multiple Ascending Dose (MAD) Evaluation 
The MAD portion of the study will also be double-blinded, randomized, placebo-controlled, 
to evaluate the safety and efficacy of two dose levels of AP-PA02, enrolling 4 subjects into 
Cohort 3 and 20 subjects into Cohort 4.  
Each cohort will be randomized at a 3:1 ratio.  
Initiation of enrollment into the MAD portion of the study will be dependent on the positive 
recommendation and concurrence of the Sponsor following the SMC review following 
Cohort 2.  
Cohort 3 of the MAD portion will be enrolled first, followed by Cohort 4. Once enrolled, 
each subject will receive one fractionated dose of AP-PA02 or placebo (one dose distributed 
over two administrations by inhalation in the same day), at least 6 hours apart, for five or ten 
consecutive days in the clinic for Cohorts 3 or 4, respectively. For Cohort 3, subjects will 
return to the clinic approximately 24 hours post-last dose for safety evaluations and phage 
titer sampling, for Visits 6 through 8, and End of Study Visit. For Cohort 4, subjects will 
return to the clinic approximately 24 hours post-last dose for safety evaluations and phage 
titer sampling, and on Visits 11 through 13, and End of Study Visit. A follow-up visit for 
safety and ADA titer will be performed at the End of Study Visit. The first two randomized 
subjects of each dose cohort will not be permitted to initiate dosing (Day 1) on the same day, 
to allow for adequate safety review. 
The SMC will review all available safety data through Visit 7 for Cohort 3 (including any 
additional safety data from the SAD cohorts collected to date), before continuing to the next 
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5.2 
Dose Escalation  
The single dose escalation scheme will test two dose levels administered once each, and the 
multiple dose escalation scheme will test two dose levels given as a fractionated dose over 
two administrations per day for five and ten consecutive days for Cohorts 3 and 4, 
respectively. As described in Section 3, the doses will be delivered to subjects via the PARI 
Investigational eFlow® device, corresponding to the dose escalation schemes are shown in 
Table 4.  
Dose levels for the SAD cohorts shown below represent the total number of PFUs in the final 
3-phage IMP formulation, with a 1:1:1 ratio of three phage components (ARPA0003, 
ARPA0022, ARPA0034), administered once per subject.  
Dose levels for the MAD cohorts shown below represent the total PFUs in the 5-phage IMP 
formulation, to be delivered per dose administration with a 1:1:1:1:1 ratio of the five phage 
components (ARPA0003, ARPA0022, ARPA0034, ARPA0002, ARPA0028), the total daily 
fractionated dose given over two administrations per day, and the total combined PFU dose 
over five and ten consecutive days for Cohorts 3 and 4, respectively. 
Table 4 
MAD Dose Exposure 
Cohort 
Each Dose 
(estimated PFUs) 
Total Daily Dose 
Fractionated over 2 
Administrations per Day 
(estimated PFUs) 
Total Dose Per 
Treatment Course 
(estimated PFUs) 
1 (single dose) 
1E10 
 
 
2 (single dose) 
3E10 
 
 
3 (BID x 5 days) 
5.75E10 
1.15E11 
5.75E11 
4 (BID x 10 days) 
1.5E11 
3E11 
3E12 
 
Initiation of MAD Cohort 3 will be based on the safety profile of SAD Cohorts 1 and 2. 
Initiation of Cohort 4 will be based on the safety profile of Cohort 3. The first two subjects of 
each cohort will not be permitted be to initiate dosing (Day 1) on the same day, to allow for 
adequate safety review.  
 
 

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5.3 
Dose Escalation Rules 
5.3.1 
Adverse Events of Interest 
The AEs of Interest listed in Table 5 are AEs commonly seen with inhaled products. If AEs 
of interest occur at a Grade 3 level or higher in two or more subjects in a cohort, then an 
additional 4 subjects (3 active, 1 placebo) may be added to the cohort. Any of the 
Grade ≥ 3 toxicities shown in the table below, as well as any other respiratory AEs reported, 
will be evaluated and considered when making dose escalation decisions. If no additional 
subjects experience any Grade ≥ 3 AEs of Interest, dose escalation may proceed (if 
recommended by the SMC).  
Table 5 
Adverse Events of Interest 
Adverse Events of Interest 
Hypotension 
Acute Bronchospasm 
Hypoxia 
Tachycardia 
Acute Urticaria 
 
5.3.2 
Definition of Dose-Limiting Toxicity (DLT) 
A Dose-limiting Toxicity (DLT) is defined as follows, determined by the Investigator as 
study drug related: 
- 
Allergic reaction requiring urgent medical intervention 
- 
Acute bronchospasm requiring urgent medical intervention 
- 
Hypotension accompanied by other evidence of a systemic inflammatory reaction or 
sepsis 
- 
Other acute AEs requiring urgent medical intervention 
 
Allergic reactions may include local dermatitis, hives, urticaria, angioedema, or anaphylaxis. 
Appropriate treatment may include administration of antihistamines, prednisone, solumedrol, 
or epinephrine at the discretion of the assessing physician. Subjects diagnosed with a 
systemic allergic reaction requiring therapy will be discontinued from the study drug, but will 
be followed through the end of study. 
Allergic reactions and acute bronchospasm not requiring intervention (Grade 1) are usually 
considered subject-specific and are not included in the definition of DLT. In this protocol, 
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included in the DLT definition since such reactions may not be product and dose-specific 
with AP-PA02. 
The Investigator will base decisions to de-escalate to a lower dose, hold the dose (delay or 
skip), or discontinue study drug for an individual subject using the study-designated toxicity 
grading scale (see Section 12.3.1) in consultation and agreement with the Sponsor’s Medical 
Monitor and/or designee. In addition to the toxicity grading scale, the Investigator should 
also review the stopping rules in Section 5.3.6 with regard to decreases in FEV1.  
If a subject experiences any acute AEs post-dose administration (regardless of causal 
relationship to study drug) that have not resolved by the time is to be discharged home 
on Day 1, it will be left up to the discretion of the Investigator to admit the subject for 
overnight continued observation, if in the best interest of the subject. 
5.3.3 
Dose Escalation Rules for SAD 
For the single dose cohorts, dose escalation to the next cohort may occur upon 
recommendation of the SMC after the safety data from all subjects through Day 8 for a given 
cohort. 
5.3.4 
Dose Escalation Rules for MAD 
For the multiple dose cohorts, dose escalation to the next cohort may occur upon 
recommendation of the SMC after the safety data from all subjects through Visit 7 for Cohort 
3.  
For the multiple dose cohorts, subjects who experience a DLT should be discontinued from 
study drug but are encouraged to remain in the study through the End of Study Visit. 
Appropriate safety evaluations should be performed within 24 hours of the DLT.  
Dose escalation will occur based on the positive recommendation of the safety data as 
assessed by the SMC at the end of each cohort.  
5.3.5 
Criteria for Study Drug Discontinuation 
Subjects should be continued on study treatment unless individual Stopping Rules have been 
met as outlined below. Study drug should be stopped and subject(s) advised regarding 
available treatment options. 
When study drug is discontinued in the MAD cohort, appropriate safety evaluations should 
be performed, and the subject should be followed for safety through the End of Study visit.  
5.3.6 
Stopping Rules  
5.3.6.1 
Stopping Rules for Study 
The SMC will evaluate the safety data through Visit 4 for SAD cohorts and Visit 7 for MAD 
Cohort 3, and on an ongoing basis to recommend if the study should continue or cease, or if 

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any modifications should be made as to how subjects are treated or managed. Study 
enrollment and dosing should be paused for SMC review for the following occurrences 
which can be cause for termination of the Study: 
a) One or more subjects experience a serious adverse (SAE) or Grade 4 adverse event 
considered at least possibly related to study drug. 
b) Two or more subjects experience the same or similar Grade 3 adverse event (AE) of 
the same system organ class (SOC). 
c) Two or more subjects experience Grade 3 or greater hypersensitivity reactions (e.g. 
difficulty breathing, rash, hypotension). 
 
5.3.6.2 
Stopping Rules for Individual Subjects 
a) Individual subjects experiencing a DLT (see Section 5.3.2 Definition of 
Dose-Limiting Toxicity) will result in discontinuation of study drug administration 
(i.e. either incomplete administration of an individual dose in the SAD, or incomplete 
administration of an individual dose and discontinuation of further dosing in the 
MAD). These subjects will continue to be followed for safety through the End of 
Study visit. 
b) For individual subjects, any of the following will result in permanent discontinuation 
of study drug. If study drug is discontinued for any of these stopping rules, 
administration will not be resumed, even after resolution of the event.  
- 
Any serious adverse event (SAE) suspected of being possibly, probably or definitely 
related to study drug 
- 
Any Grade ≥ 3 AE suspected of being related to study drug 
- 
Acute bronchospasm defined as a decrease in absolute FEV1 volume of ≥ 15% 
accompanied by symptoms requiring medical intervention, occurring from baseline 
value up to four hours following study drug administration, persisting following 
administration of a short-acting bronchodilator 
- 
Acute pulmonary exacerbation confirmed by the Investigator based on clinical 
findings including fever, weight loss and/or generalized malaise associated with 
increased dyspnea, cough, change in sputum quantity or quality, or new 
infiltrate/consolidation on imaging 
- 
Unacceptable toxicity considered by the Investigator to be related to study drug 
treatment 
- 
Further treatment is deemed to be unsafe in the Investigator’s clinical judgment. The 
decision to discontinue a subject may also result from any clinically significant 
alteration in any clinical or laboratory finding  
- 
If at any time the subject fails to follow the requirements of the protocol  
- 
The subject withdraws consent. Subjects may withdraw from the study at any time 
without repercussion to their treatment or affiliation with their healthcare providers.  

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For individual subjects in the MAD cohorts, if the pre-first dose absolute FEV1 volume on a 
given dosing day is < 15% of the baseline absolute FEV1 volume (the pre-first dose value on 
Day 1), dosing should be held for that day and resumed the following day. If on the 
subsequent day the FEV1 volume is still <15% of the baseline value on Day 1, study drug 
should be discontinued permanently, and the subject should continue to be followed for 
safety through the End of Study visit. 
5.4 
Study Completion and Discontinuation Criteria 
5.4.1 
Study Completion 
Subjects who receive all planned study drug doses and complete all post-dose evaluations 
will be considered to have completed the study. 
Subjects who were randomized into a SAD cohort, and who received at least 1 study drug 
dose are not eligible to participate in a subsequent SAD cohort or in a MAD cohort. 
5.4.2 
Study Withdrawal 
A subject will have the right to withdraw from the study at any time for any reason. 
A subject will be discontinued from the study by the Investigator if unacceptable toxicity or 
withdrawal of consent occurs. 
Subjects withdrawn from SAD cohorts should have all assessments conducted at the End of 
Study Visit at the time of withdrawal. Subjects withdrawn from MAD cohorts should have 
all assessments conducted at the End of Treatment Visit as well as the End of Study Visit, for 
safety monitoring purposes.  
Allergic reactions may include local dermatitis, angioedema, throat constriction, or 
anaphylaxis. Appropriate treatment may include administration of antihistamines, 
hydrocortisone, or epinephrine at the discretion of the assessing physician. Subjects 
diagnosed with a systemic allergic reaction requiring therapy will be withdrawn from the 
study. 
Given the proposed mechanism of action of AP-PA02, it could be anticipated that subjects 
could experience a change in baseline cough, change in sputum quality, or change in sputum 
volume. A pulmonary exacerbation should be considered if these symptoms are accompanied 
by fever, body weight loss, and/or generalized malaise. If a pulmonary exacerbation is 
diagnosed, appropriate interventions including appropriate additional antibiotics should be 
prescribed by the Investigator or treating physician. Subjects diagnosed with a pulmonary 
exacerbation requiring the addition of antibiotics will be discontinued from study drug, but 
will continue to be followed for safety through the End of Study visit. 
5.4.3 
Study Termination 
If the Sponsor, SMC, Sponsor’s Medical Monitor or designee, study monitor, or appropriate 
regulatory officials discover conditions arising during the study that indicate that the study 

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should be halted or that a study center should be terminated, this action may be taken after 
appropriate consultation. Termination may occur in accordance with the clauses contained in 
the site’s executed clinical trial agreement. Armata Pharmaceuticals, Inc. reserves the right to 
discontinue the trial prior to enrollment of the intended number of subjects, but intends only 
to exercise this right for valid scientific or administrative reasons. 
If the clinical development of AP-PA02 is discontinued, the Sponsor shall immediately 
inform all trial Investigators/institutions and regulatory authorities. Study termination and 
follow-up will be performed in compliance with the conditions set forth in the ICH E6(R2) 
on GCP guidelines and local regulatory requirements. 

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6 
STUDY POPULATION  
6.1 
Selection of Subjects 
Subjects with cystic fibrosis and chronic pulmonary Pa infection who meet all inclusion and 
exclusion criteria will be eligible for participation in this study. 
6.1.1 
Inclusion Criteria  
1. Able and willing to comply with the protocol and provide written informed consent prior 
to study-specific procedures 
2. Male or female ≥ 18 years old at the time of Screening 
3. Body mass index (BMI) of ≥ 18 kg/m2  
4. Must have confirmed diagnosis of cystic fibrosis, as documented by one of the following 
criteria:  
a. Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test performed 
at or prior to Screening -OR- 
b. Known disease-causing mutations in the CFTR gene on each chromosome.  
5. Clinically stable with no significant changes in health status within the 7 days prior to 
and including the Screening Visit 
6. Evidence of chronic pulmonary Pa infection. Evidence includes one or more of the 
following: 
a. Microbiological evidence of pulmonary Pa infection within the last 24 months 
b. Current utilization of chronic-suppressive inhaled antibiotics for Pa  
c. Oral or parenteral antipseudomonal therapy administered within the last 2 years  
7. Willing to undergo sputum induction procedures at Screening, Baseline and at designated 
time points during the study, and willing to provide expectorated sputum samples at all 
other timepoints (for subjects who are able to expectorate). 
8. Must have ≥104 CFU of Pa per gram of induced sputum obtained at Screening 
9. Subject’s Pa isolates are susceptible to AP-PA02, based on morphotypes obtained from 
induced sputum obtained at Screening. 
10. For SAD: FEV1 ≥ 60% of predicted normal for age, gender, race and height [using 
Global Lung Function Initiative (GLI) standards] at Screening (regardless of the timing 
of the most recent prior administration of short-acting bronchodilator). 
For MAD: FEV1 ≥ 40% of predicted normal for age, gender, race and height [using 
Global Lung Function Initiative (GLI) standards] at Screening (regardless of the timing 
of the most recent prior administration of short-acting bronchodilator). 
 

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11. Stable lung function, determined by the Investigator, provided that the FEV1 at the 
Baseline Visit has not decreased by more than 5% compared to the FEV1 measured at 
Screening. 
12. Able to reproducibly perform pulmonary function tests per ATS/ERS standards. 
13. For subjects to be enrolled into Part 1 of the protocol (SAD), dosing relative to their 
inhaled antibiotics schedule is not restricted; subjects participating in Part 1 SAD may 
schedule Day 1 at any time. For subjects to be enrolled into Part 2 of the protocol 
(MAD), if on inhaled antibiotics for chronic suppression of P. aeruginosa: 
a. Subjects on a single, chronically-administered inhaled antipseudomonal antibiotic or 
on two or more alternating inhaled antipseudomonal antibiotics, must remain on the 
same regimen from Screening through the end of the study. Day 1 can be scheduled at 
any time. 
b. Subjects on a chronically-administered routine of an intermittent inhaled 
antipseudomonal antibiotic (one month “on”, one month “off”) must be at least 6 days 
and not more than 17 days into the on- or off-month on Day 1. 
c. Subjects on a chronically-administered routine of inhaled antipseudomonal antibiotic, 
not following a monthly on/off inhaled antibiotic schedule, may be enrolled provided 
the subject is on the on-cycle of the inhaled antibiotic from the Baseline Visit through 
approximately 14 days after the last study drug dose. 
d. Subjects not on chronically-administered inhaled antipseudomonal antibiotics may be 
scheduled for Day 1 at any time. 
14. Creatinine clearance > 80 mL/min, as calculated by Cockcroft-Gault equation based on 
actual body weight 
15. Ability to comply with study visits and study procedures as judged by the investigator  
16. Female subjects of childbearing potential must agree to use a highly effective method of 
birth control (defined as those, alone or in combination, that result in a low failure rate 
[i.e. less than 1% per year]) from Day 1 through 60 days following the last dose of study 
drug. 
17. Male subjects must agree to use barrier contraception (i.e. condoms) from Day 1 through 
60 days following the last dose of study drug.  
18. The following criteria relate to acceptable laboratory values at Screening.  
a. Hemoglobin > 8 g/dL 
b. WBC < 14,000/µL 
c. Platelet count > 150 x 103/µL 
d. Prothrombin time (PT), International Normalized Ratio (INR) and partial 
thromboplastin time (PTT) within normal limits. Subjects with values outside the 
normal range may be permitted if the value is not clinically significant in the opinion 
of the Investigator, with concurrence from the Study Medical Monitor and/or Sponsor 
designee. 

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6.1.2 
Exclusion Criteria  
1. Decrease in body weight within 90 days prior to Screening that is considered clinically 
significant by the Investigator 
2. Abnormal vital signs at Screening: heart rate > 110 beats per minute (bpm) at rest; 
systolic blood pressure > 160 or < 90 mmHg; respiration rate > 24 bpm; and SpO2 < 92% 
at rest on room air 
3. Subject history of, or patient-reported family history of, prolonged QT syndrome; or a 
QTc interval > 450 msec (males) or > 470 msec (females) using Fredericia’s formula 
(QTcF)  
4. Use of supplemental oxygen during the day at rest 
5. Serum albumin < 2.5g/dL  
6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values greater than 
3X the upper limit of normal (ULN) at Screening. 
7. Oral or parenteral antibiotics received within 30 days prior to the Baseline Visit for acute 
pulmonary exacerbation. Inhaled antibiotic use for chronic suppression of P. aeruginosa 
is acceptable. 
8. Any infection as determined to be clinically significant in the opinion of the Investigator 
with concurrence from the Sponsor’s Medical Monitor and/or designee that results in 
receiving new systemic antimicrobial therapy within 30 days prior to the Baseline Visit. 
9. Currently receiving anti-pseudomonal antibiotic treatment for acute sinusitis. 
10. Currently receiving systemic corticosteroids at a dose greater than the equivalent of 10 
mg/day of prednisone  
11. Currently receiving treatment for active infection with nontuberculous mycobacteria 
(NTM), Staphylococcus aureus, or Burkholderia cepacia complex lung infection. 
12. Currently receiving treatment for aspergillosis or ABPA (allergic bronchopulmonary 
aspergillosis) 
13. Subject initiated on a CFTR potentiator/corrector therapy, such as Trikafta®, less than 
90 days prior to Screening. 
14. Acquired or primary immunodeficiency syndromes 
15. Active pulmonary malignancy (primary or metastatic) or any malignancy requiring 
chemotherapy or radiation therapy within one year prior to screening or anticipated 
during the study period 
16. History of lung transplantation 
17. Hemoptysis of greater than 30 mLs (cumulative) within 90 days prior to Day 1 or 
hospitalization for hemoptysis within 6 months of Day 1 
18. Female pregnant or breastfeeding 

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19. Use of any investigational device or administration of any investigational products within 
8 weeks or five therapeutic half-lives prior to study Day 1, whichever is longer. 
20. Smoking more than 10 cigarettes or 2 cigars or 2 pipes per day, or nicotine equivalent 
from vaping, from within 3 months prior to screening through the end of the study.  
21. Presence or medical history of clinically significant condition which precludes study 
participation or prevents determination of outcome measures. 
22. Any severe, acute, or chronic medical or psychiatric condition, laboratory abnormality, or 
other condition other than CF that, in the opinion of the Investigator, participation in the 
study is not in the best interest of the patient, puts the subject at undue risk, interferes 
with the results of the study, or makes the subject otherwise unsuitable for study 
participation. 
23. Prior participation in study AP-PA02-101. Subjects previously enrolled in this study and 
received at least one dose of study drug are ineligible for re-enrollment. 
 

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7 
CONCOMITANT MEDICATIONS AND ANCILLARY THERAPY 
7.1 
Inhaled Antipseudomonal Antibiotics 
7.1.1 
Part 1 SAD Subject Scheduling 
Subject dosing relative to their inhaled antibiotics schedule is not restricted. Subjects 
participating in Part 1 SAD may schedule Day 1 at any time. 
7.1.2 
Part 2 MAD Subject Scheduling 
Initiation of subject dosing (Day 1) is limited for subjects participating in Part 2 MAD 
relative to their inhaled antibiotics schedule, as described below. 
7.1.2.1 
Chronic Continuous Therapy 
Subjects who are on chronically-administered inhaled antipseudomonal antibiotics on 
a continuous basis (the same inhaled antibiotic, no interruption of therapy or use of 
alternate antibiotic) should remain on the same therapy from Screening through the 
end of the study. Day 1 may be scheduled at any time during the subject’s inhaled 
antipseudomonal antibiotic regimen. 
7.1.2.2 
Chronic Alternating Therapy (CAT) 
Subjects who are on a chronically-administered routine of two or more alternating 
antipseudomonal antibiotics should remain on the same therapy from Screening 
through the end of the study. Day 1 may be scheduled at any time during the subject’s 
inhaled antipseudomonal antibiotic regimen. 
7.1.2.3 
Chronic Intermittent Therapy (CIT) 
• Subjects who are on a chronically-administered routine of intermittent 
antipseudomonal antibiotics (“on” one month, “off” one month) should be 
scheduled to initiate study drug dosing (Day 1) and must be at least 6 days and 
not more than 17 days into the on- or off-month on Day 1. 
• Subjects not following a monthly on/off inhaled antibiotic schedule may be 
enrolled provided the subject is on the on-cycle of the inhaled antibiotic from 
the Baseline Visit through approximately 14 days after the last study drug 
dose. 
7.2 
Chest Physiotherapy 
Any chest physiotherapy techniques utilized by an individual subject should remain 
consistent throughout the study. The order in which chest physiotherapy techniques are 
performed, in relation to other medications and administration of study drug should remain 
consistent throughout the study. 

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7.3 
Order of Therapies 
Prior to study drug dosing on a given day, any concurrent treatments that the subject receives 
at baseline should be administered in the following order: Long- and/or Short-acting 
bronchodilator, mucolytic therapy (e.g. Pulmozyme), chest physiotherapy (airway clearance 
technique), inhaled corticosteroid, inhaled antibiotics, and lastly, administration of study 
drug. Administration of these therapies should be performed in the same order each dosing 
day, prior to spirometry and study drug dosing. 
Ancillary therapy regimens and airway clearance techniques should remain consistent 
throughout the study period. 
7.4 
 CFTR Potentiators/Correctors 
Subjects should not be initiated on CFTR potentiators/correctors within 90 days prior to 
Screening, or during the study. Changes to such therapy prior to or during the study are 
permitted, with concurrence from the study Medical Monitor and/or Sponsor designee, and 
should be documented in the eCRF. 
7.5 
Ancillary Therapy 
Other ancillary therapy may be administered at the discretion of the Investigator. Subjects 
should receive full supportive care, including antibiotics, antiemetics, bronchodilators, etc., 
as appropriate. The reason(s) for ancillary therapy, including dosage and date(s) of treatment, 
will be recorded in the source documents. 
7.5.1 
Premedication 
For subjects whose standard CF medications include a short-acting β-agonist (SABA) and/or 
a long-acting β-agonist (LABA), the most recent time of administration of the SABA and/or 
LABA prior to each study drug dose should be recorded. 
7.5.2 
Prohibited Concomitant Medications 
Oral corticosteroid medications may not be used prophylactically with any dose of study 
drug. Chronic administration of oral corticosteroids at a stable dosage up to 10 mg/day for at 
least 30 days prior to enrollment are permitted. The reason(s) for ancillary therapy, including 
dosage and date(s) of treatment, will be recorded in the source documents. Subjects started 
on oral corticosteroids after randomization should be withdrawn from study drug, and should 
remain on study through the End of Study visit. 
7.6 
Adequate Forms of Birth Control 
Women of childbearing potential must agree to use a highly effective method of birth control 
from the list below (defined as those, alone or in combination, that result in a low failure rate, 
ie, less than 1% per year when used consistently and correctly). Double barrier methods (a 
combination of condom with cap, diaphragm, or sponge with spermicide) are not considered 
highly effective. Childbearing potential is defined as being fertile following menarche and 

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until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods 
include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. 
Highly effective methods of birth control include: 
• Combined (estrogen and progesterone containing) hormonal contraception associated 
with inhibition of ovulation (oral, intravaginal, transdermal) 
• Progesterone-only hormonal contraception associated with inhibition of ovulation (oral, 
injectable, implantable) 
• Intrauterine device (IUD) 
• Intrauterine hormone-releasing system (IUS) 
• Bilateral tubal occlusion 
• Vasectomized partner (provided that partner is the sole sexual partner and has received 
medical assessment of the surgical success) 
• Sexual abstinence. Sexual abstinence must be true abstinence which is the preferred and 
usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, 
symptothermal, post-ovulation methods), declaration of abstinence for the duration of the 
trial, and withdrawal are not acceptable methods of contraception. 
 
Birth control measures must be employed during the time of participation (beginning at the 
Screening Visit) in this trial. Protections against pregnancy must be continued for at least 
60 days after the last dose of study drug. 
A man is considered fertile after puberty unless permanently sterile by bilateral orchiectomy. 
Male subjects with CF with medical confirmation of azoospermia and/or infertility will be 
considered permanently sterile. A man who is fertile should use a condom during treatment 
and until 60 days after the last dose of study drug. 
7.7 
Adverse Reaction Management 
AEs in the study will be treated with appropriate therapies. Acute bronchospasm (defined as 
a ≥ 15% decrease in FEV1 absolute volume from pre-dose (first dose) to post-dose on a given 
dosing day) should be treated with treatment cessation and inhaled β2 agonists; IV 
solumedrol or other agents should be administered as deemed appropriate by the Study 
Investigator. Additional supportive care should be provided as necessary by qualified staff 
with emergency resuscitation equipment.  
A Grade 3 adverse reaction requires interruption of dosing in the SAD and MAD cohorts and 
permanent discontinuation of study drug in the MAD cohorts. 

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8 
EVALUATIONS BY VISIT  
All tests and procedures are detailed in Appendix 1, Schedule of Assessments. Refer to these 
appendices for the required assessments for each study day. Throughout the protocol, the 
term “baseline” is used to refer to tests or procedures performed at screening, Baseline Visit, 
or on Day 1 prior to the time of administration of the first dose. 
8.1 
Visit and Assessment Windows 
The flexibility regarding scheduling of study days relative to Day 1 are specified in the 
Schedule of Study Procedures tables in the Appendices. The timing of assessments, 
procedures and sample collections outlined in the protocol are nominal times. It is understood 
that in the phase 1 setting, actual times will approximate rather than match the nominal times 
exactly. Actual times are to be recorded in the source documentation and in the case report 
forms (CRFs), and, if any time points are missed, the reasons should also be recorded. 
The MAD doses should be administered on consecutive days. Missed doses are to be 
recorded as such. If dosing is held and postponed to the next day, doses should be recorded 
as “delayed”, along with the reason for the delayed administration. If the MAD Day 2 doses 
are delayed, and are administered on Day 3, the doses originally scheduled for administration 
on Day 3 will be then administered on Day 4, and so on. All subsequent study days will be 
conducted as outlined in the Table of Assessments, but pushed out by a day (Day 4 
procedures will be conducted on Day 5, etc.). 
Dosing delays should not exceed more than one day. If greater than one day of delay of 
dosing occurs, the subject should be withdrawn from study drug, but should continue to be 
followed for safety through the End of Study Visit. 
Details regarding acceptable windows for timing of study procedures for both the SAD and 
MAD cohorts can also be found in the Study Manual. 
8.2 
Screening Visit (All Cohorts) 
A screening log of all consented subjects will be kept at each site. Subject screening will be 
conducted up to 35 days prior to study drug dosing (Day 1). Screening evaluations may be 
completed over several days, if necessary. If the screening period extends beyond 35 days, 
the potential subject will be considered a screening failure, but may be re-screened at a later 
date.  
All screening evaluations must be reviewed by the Investigator to establish subject eligibility 
before dosing the subject for this study. Local laboratory results will determine subject 
eligibility for laboratory criteria, except for presence of Pa in sputum at Screening, and Pa 
isolate susceptibility to AP-PA02 (performed at a central laboratory). Subjects may be 
allowed to submit a repeat induced sputum sample for eligibility (if time allows during the 
35-day Screening Period), if the initial sample is unusable or negative for Pa. 

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8.3 
Baseline Visit (All Cohorts) 
The Baseline Visit will be scheduled between Day -7 and Day -1 (inclusive) relative to Visit 
1 Day 1 for all cohorts. Screening evaluations cannot be combined with evaluations 
performed as part of the Baseline Visit, unless results are obtained and reviewed by the 
Investigator, and eligibility can be confirmed prior to randomization. 
 

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9 
STUDY PROCEDURES 
Safety parameters will be assessed by monitoring AEs, vital signs, oximetry, laboratory data 
(chemistries, hematology and urinalysis), ECGs, pulmonary function (spirometry), and 
physical examinations. Subjects not fulfilling the eligibility criteria, or were randomized but 
not dosed, may be rescreened for participation if their eligibility characteristics change. 
Screening procedures that fall within the screening window do not need to be repeated. 
Subjects that previously failed screening, or were randomized but not dosed, may undergo re-
screening under a new Subject Number for confirmation of eligibility and enrollment into the 
study at a later date, with approval from the study Medical Monitor and/or Sponsor designee. 
9.1 
Vital Signs 
Blood pressure, heart rate, respiration rate, and temperature will be measured at rest in a 
sitting position. At Screening, if vital signs measured are not within the stated eligibility 
limits, it is permissible to allow the subject to rest at least another 10-15 minutes and repeat 
the vital signs measurements. 
For SAD cohorts, vital signs will be measured at Screening, Baseline, Day 1 pre-dose, 10, 30 
and 60 minutes post-dose, and 2, 4 and 7 hours post-dose. Vital signs will also be measured 
at Visits 2, 3, 4, 5, and 6. 
For MAD Cohort 3, vital signs will be measured at Screening, Baseline, and at the following 
timepoints on dosing days (see also Appendix 1 Tables D and E): 
Table 6 
MAD Cohort 3 Vital Signs Timepoints on Dosing Days 1-5 
Visit Day 
Dose 
Timepoints on Dosing Days 
1 
1 
1 
Pre-dose, 10 minutes and 60 minutes post-dose 
2 
Pre-dose (approximately 6 hours post-dose 1), 1-hour post-Dose 2 
2 
2 
3 
Pre-dose, 10 minutes and 60 minutes post-dose 
4 
Pre-dose (approximately 6 hours post-Dose 3), 1-hour post-Dose 4 
3 
3 
5 
Pre-dose, 10 minutes and 60 minutes post-dose 
6 
Pre-dose (approximately 6 hours post-Dose 5), 1-hour post-Dose 6 
4 
4 
7 
Pre-dose, 10 minutes and 60 minutes post-dose 
8 
Pre-dose (approximately 6 hours post-Dose 7), 1-hour post-Dose 8 
5 
5 
9 
Pre-dose, 10 minutes and 60 minutes post-dose 
10 
Pre-dose (approximately 6 hours post-Dose 9), 1-hour post-Dose 10 
 
For MAD Cohort 3, vital signs will also be measured at Visits 6, 7, 8, and 9. 

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For MAD Cohort 4, vital signs will be measured at Screening, Baseline, and at the following 
timepoints on dosing days (see also Appendix 1 Tables G, H and I): 
Table 7 
MAD Cohort 4 Vital Signs Timepoints on Dosing Days 1-10 
Visit 
Day 
Dose 
Timepoints on Dosing Days 
1 
1 
1 
Pre-dose, 10 minutes and 60 minutes post-dose 
2 
Pre-dose and 1-hour post-Dose 2 
2 
2 
3 
Pre-dose and 60 minutes post-dose 
4 
Pre-dose and 1-hour post-Dose 4 
3 
3 
5 
Pre-dose and 60 minutes post-dose 
6 
Pre-dose and 1-hour post-Dose 6 
4 
4 
7 
Pre-dose and 60 minutes post-dose 
8 
Pre-dose and 1-hour post-Dose 8 
5 
5 
9 
Pre-dose and 60 minutes post-dose 
10 
Pre-dose and 1-hour post-Dose 10 
6 
6 
11 
Pre-dose and 60 minutes post-dose 
12 
Pre-dose and 1-hour post-Dose 12 
7 
7 
13 
Pre-dose and 60 minutes post-dose 
14 
Pre-dose and 1-hour post-Dose 14 
8 
8 
15 
Pre-dose and 60 minutes post-dose 
16 
Pre-dose and 1-hour post-Dose 16 
9 
9 
17 
Pre-dose and 60 minutes post-dose 
18 
Pre-dose and 1-hour post-Dose 18 
10 
10 
19 
Pre-dose and 60 minutes post-dose 
20 
Pre-dose and 1-hour post-Dose 20 
 
For MAD Cohort 4, vital signs will also be measured at Visits 11, 12, 13, and 14. 
9.2 
Oximetry 
Digital oximetry (SpO2) will be measured at rest in a sitting position. Oximetry will be 
measured at all timepoints where vital signs are measured. 
9.3 
Local Laboratory Evaluations 
Safety laboratory evaluations will be performed according to the study schedule, using the 
clinical site’s local laboratory. Repeat of Screening laboratory evaluations are permissible to 
confirm eligibility.  
Blood samples for clinical laboratory testing (serum chemistries and hematologies) obtained 
pre-dose on Day 1 (for all cohorts), if abnormal and clinically significant at Baseline, results 
are to be reviewed by Investigator prior to administration of study drug. 
Safety laboratory samples will be obtained at Screening and Baseline, and at the additional 
following timepoints: 
• For SAD cohorts: Visits 2, 3, 4, and 5. 

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• For MAD Cohort 3: Visits 2, 5, 7, and 8. Blood samples for clinical laboratory testing 
to be obtained pre-first dose on Visits 2 and 5, and results reviewed by Investigator 
prior to administration of study drug on those days. 
• For MAD Cohort 4: Visits 2, 10, 12, and 13. Blood samples for clinical laboratory 
testing to be obtained pre-first dose on Visits 2 and 10, and results reviewed by 
Investigator prior to administration of study drug on those days. 
 
9.3.1 
Serum Chemistry 
Serum chemistries will include sodium, potassium, chloride, bicarbonate, blood urea nitrogen 
(BUN), creatinine, glucose, calcium, phosphorus, ALT, AST, alkaline phosphatase, albumin, 
bilirubin (total and direct). Creatinine clearance is to be calculated using the Cockcroft-Gault 
equation adjusted for actual body weight.  
9.3.2 
Hematology 
Hematologies will include a complete blood count (CBC), which includes hematocrit, 
hemoglobin, platelet count, and white blood count (with absolute and/or relative differential, 
as reported by the site’s local laboratory). 
9.3.3 
Coagulation 
Coagulation testing (PT-INR, PTT) to be performed at Screening for eligibility. 
9.3.4 
Urine Testing  
9.3.4.1 
Urinalysis 
Urinalysis will be performed at time points designated by the study schedule (and listed 
below) at the local laboratory. Urinalysis will be performed by visual inspection and dipstick, 
and will include color and appearance, specific gravity, pH, protein, glucose, occult blood, 
ketones, bilirubin, leukocyte esterase, nitrite, and urobilinogen. In addition, microscopic 
analyses will be performed on samples with abnormal dipstick results. 
Urine samples for urinalysis to be obtained pre-dose on Day 1 (for all cohorts), if abnormal 
and clinically significant at Baseline, and results reviewed by Investigator prior to 
administration of study drug. 
Urine samples will be obtained at Screening and Baseline, and at the additional following 
timepoints: 
• For SAD cohorts: Visits 2 and 5. 
• For MAD Cohort 3: Visits 6 and 8. 
• For MAD Cohort 4: Visits 10 and 13. 

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9.3.4.2 
Pregnancy 
For female subjects, a pregnancy test will be obtained as designated by the study schedule. 
Urine or serum pregnancy testing are allowed. 
9.4 
Central Laboratory Evaluations 
9.4.1 
Serology 
Serum samples will be obtained at specified time points during the study to determine if titers 
of anti-drug antibodies (ADA) are detectable. Serology samples will be batch-analyzed at the 
end of the study and will be stored for additional testing if titers are detected.  
In the current COVID-19 environment, it is possible that exposure to SARS-CoV2 may have 
an impact on the outcomes measured in this study. Therefore, serum samples will be obtained 
at specified time points during the study and stored for possible future testing for the 
presence of SARS-CoV2 antibodies. 
Serology samples to be collected at the following timepoints: 
• For SAD cohorts: Baseline, and Visits 5 and 6. 
• For MAD Cohort 3: Baseline, and Visits 8 and 9. 
• For MAD Cohort 4: Baseline, and Visits 13 and 14. 
 
9.4.2 
Sputum Microbiology 
Sputum for microbiology will be obtained as designated by the study schedule and processed 
at a central laboratory for all visits. Pseudomonas aeruginosa isolates obtained from sputum 
samples at all visits will be frozen for possible future genotyping analysis. No subject 
(human) samples will be retained for any genetic analysis.  
Collection of sputum via induction for all subjects (regardless of their ability to 
spontaneously expectorate sputum), will be performed per standardized methodology at the 
timepoints specified in the Schedule of Procedures tables in Appendix 1. Standardized 
sputum induction methodology to be detailed in the Study Manual. 
For expectorated sputum collection, subjects may be asked to provide first morning samples 
expectorated before a given clinic visit or the subjects may provide the expectorated sputum 
sample during the clinic visit. Samples collected at home by the subject should ideally be 
collected prior to administration of any inhaled antipseudomonal antibiotic. Subjects will be 
provided sputum collection vessels and insulated transport containers in which to carry their 
specimens to the clinic. 

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9.4.3 
Phage Recovery Evaluations 
Samples for phage recovery analyses will be collected as detailed in Appendix 1. Detailed 
instructions for sample collection and shipment to the central lab for analysis will be 
provided in the study laboratory manual. 
9.4.3.1 
Blood 
Blood samples, when scheduled at time points when safety labs and phage titer samples are 
also to be collected, safety lab samples are to be collected first, followed by phage titer 
samples.  
9.4.3.2 
Sputum 
Expectorated and/or induced sputum samples for phage titers can be difficult to obtain at the 
specified time points. It is suggested that samples be collected in conjunction with 
spirometry, as often spirometry maneuvers can provoke coughing and sputum expectoration.  
9.4.3.3 
Urine 
Urine samples for phage recovery will be obtained at the visits indicated in the Schedule of 
Assessments table using provided collection containers. Date and time will be recorded for 
each urine sample collection at the designated time points. 
9.5 
Electrocardiogram (ECG) 
A 12-lead ECG will be performed locally at the site, and obtained at Screening, and pre-dose 
and 1 hour post dose on Day 1 for all subjects enrolled in SAD cohorts. For subjects enrolled 
into MAD cohorts, a 12-lead ECG will also be performed at the End of Study Visit. 
The Fridericia formula (Vandenberk et al. 2016) for calculating QTc will be used (QTcF). 
9.6 
Spirometry 
Spirometry will be performed per ATS/ ERS Standards (Miller et al. 2005; Pellegrino et al. 
2005; Wanger et al. 2005; Quanjer et al. 2012; Graham et al. 2019), and evaluated locally at 
the clinical study site. FEV1, FVC, and FEF25-75 will be collected. Actual liter values will be 
recorded. Details regarding spirometry procedures and standards will be included in the 
Study Manual. 
For SAD cohorts, spirometry will be performed at Screening, Baseline, Day 1 pre-dose; 30 
minutes, 60 minutes and 7 hours post-dose. Spirometry will also be performed at Visits 2, 3, 
4, 5, and 6. 

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For MAD cohorts, spirometry will be performed at Screening, Baseline, and at the following 
timepoints on dosing: 
For MAD Cohort 3 (Visits 1-5), (See Appendix 1, Tables D and E): 
• Visit 1: Pre-Dose, 30 minutes, and at 2 and 7 hours post-first dose (approximately 1 
hour post-Dose 2) 
• Visits 2 through 5: Pre-first dose, 30 minutes and 7 hours post-first dose of the day 
(approximately 1 hour post-second dose of the day) 
• Spirometry will also be performed at Visits 6, 7, 8, and 9. 
 
For MAD Cohort 4 (Visits 1-4 and 8-10), (See Appendix 1, Tables G, H, and I): 
• Visit 1: Pre-Dose 1, 30 minutes, and at 2 and 7 hours post-first dose (approximately 1 
hour post-Dose 2)  
• Visits 2 through 4, and Visits 8 through 10: Pre-first dose, 30 minutes and 7 hours 
post-first dose of the day (approximately 1 hour post-second dose of the day)  
• Spirometry will also be performed at Visits 11, 12, 13, and 14. 
 
9.7 
Physical Examination 
Complete physical examinations (urogenital exams not required) will be performed at 
Screening, Baseline and Visit 5 for subjects enrolled in the SAD cohorts. For MAD Cohorts, 
complete physical examinations will be performed at Screening, Baseline, and/or at the EOS 
Visit Symptom-directed physical exams will be performed at all other time points, as 
indicated by the study schedule. 
9.8 
Height and Weight 
Height will be measured using a calibrated, wall-mounted stadiometer and will be 
documented at the Screening Visit. Body weight will be measured using a calibrated scale 
per study schedule. 
9.9 
Sweat Chloride and Genotyping 
Documentation of cystic fibrosis by either of the following is required for study eligibility: 
1. Sweat chloride by pilocarpine iontophoresis of ≥ 60 mmol/L performed at or prior to 
Screening -OR- 
2. Documentation of known disease-causing mutations in the CFTR gene on each 
chromosome. 

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If historical sweat chloride or CFTR genotyping results are not available, a sweat chloride 
test or CFTR genotyping should be performed to determine study eligibility. If the historical 
(or Screening) sweat chloride value is ≥ 30 mmol/L but less than 60 mmol/L, the subject 
must also have CF genotyping performed, and have at least one disease-causing mutation in 
the CFTR gene on each chromosome.  
9.10 
CFQ-R 
The CFQ-R subject health-related quality of life questionnaire (Quittner et al. 2005) will be 
administered using the self-administered format (Adult version) [Appendix 2], according to 
the study schedule for all subjects. The CFQ-R will be administered prior to any other test or 
procedure on each of the required study days. The CFQ-R responses will be entered into the 
eCRF by clinical site staff. 
9.11 
CFRSD-CRISS 
The Cystic Fibrosis Respiratory Symptom Diary – Chronic Respiratory Infection Symptom 
Score (CFRSD-CRISS) is an 8-item patient-reported outcome (PRO) symptom measure that 
is part of the Cystic Fibrosis Respiratory Symptom Diary [Appendix 3]. The CFRSD-CRISS 
is designed to evaluate the effect of treatment on the severity of symptoms of respiratory 
infection in adults and adolescents (> 12 years) with CF and a chronic respiratory infection 
(Goss et al. 2009). Symptoms assessed in the CFRSD-CRISS are: difficulty breathing, cough, 
cough up mucus, chest tightness, wheeze, feeling feverish, tired, and chills/sweats. 
The CFRSD daily diary will be dispensed to study subjects starting at the Baseline Visit for 
all subjects. Subjects will be instructed to bring the diary to the clinic for each subsequent 
study visit and will be collected at the End of Study Visit. The CFRSD responses will be 
entered into the eCRF by clinical site staff. 

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10 
SAFETY ASSESSMENTS 
All subjects who receive study drug will be assessed for safety.  
Investigators are responsible for monitoring the safety of subjects who have entered this 
study and for alerting the Sponsor regarding any event that seems unusual, even if this event 
may be considered an unanticipated benefit to the subject. The Investigator is responsible for 
appropriate medical care of subjects during the study. 
10.1 
Safety Monitoring Committee (SMC) 
The SMC will provide safety oversight for the study. Several SMC members have significant 
experience with oversight of cystic fibrosis clinical trials, appointed by the Cystic Fibrosis 
Foundation Data Safety Monitoring Board. A SMC operational charter will be finalized prior 
to randomization of the first subject. The SMC will review blinded safety data from each 
cohort, and provide their recommendation for proceeding to the next dosing cohort, and for 
proceeding from the SAD phase to the MAD phase of the study, as described in Section 5.  
10.2 
Adverse Events  
10.2.1 
Definition 
An AE is any untoward medical occurrence associated with the use of a drug in humans, 
whether or not considered drug related. AEs can include any unfavorable, noxious, 
unintended sign, symptom, or disease temporally associated with use of an 
investigational medicinal product or other protocol-imposed intervention, regardless of 
attribution. AEs may be spontaneously reported by the subject, discovered by Investigator 
questioning, or detected through physical examination, laboratory test, or other means. 
AEs include: 
- 
Pre-existing medical conditions judged by the Investigator to have worsened in 
severity or frequency or changed in character during the protocol-specified AE 
reporting period 
- 
AEs not previously observed in the subject that emerge during the protocol-specified 
AE reporting period (as specified in Section 10.4.1)  
- 
Complications that occur as a result of protocol-mandated interventions (e.g. invasive 
procedures such as blood draws) 
- 
AEs that occur prior to assignment of study treatment that are related to a 
protocol-mandated intervention (e.g. invasive procedures such as blood draws, 
medication washout, or no treatment run-in) 
 
10.3 
Assessment of Adverse Events  
The Investigator is responsible for assessing the severity and causality of AEs. 

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10.3.1 
Assessment of the Severity (Intensity) of Adverse Events 
Maximum intensity is to be graded using the Common Terminology Criteria for Adverse 
Events (CTCAE), Version 5.0 (U.S. Department of Health and Human Services, 2017). If the 
CTCAE reference table does not include grading criteria for the event, the criteria in the table 
below will be used. 
Table 8 
Adverse Event Intensity (Severity) Scale  
Grade 
Severity 
Description of the Adverse Event 
1 
Mild 
Asymptomatic or mild symptoms; clinical or diagnostic observations 
only; intervention not indicated. 
2 
Moderate 
Minimal, local, or noninvasive intervention indicated; discomfort 
sufficient to reduce or interfere with daily activities. 
3 
Severe 
Medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization may be indicated; 
disabling; limits self-care with significant interference with daily 
activities; incapacitating with inability to perform self care activities of 
daily living. 
4 
Life-threatening 
Urgent intervention indicated; immediate risk of death. 
5 
Death 
 
Note: Regardless of severity, some events may also meet regulatory serious criteria. Refer to definitions of an 
SAE. 
 
Any AE that meets the seriousness criteria (see Section 10.5, Serious Adverse Event 
Definition) will be considered an SAE, including all life-threatening AEs. In addition, AEs 
with Grade 4 intensity may be considered serious if the event is determined to be clinically 
significant. 
10.3.2 
Assessment of the Relationship of Adverse Events to Study Drug 
The Investigator will make a causality assessment about the relationship of each AE to study 
drug. Treatment-related conditions must be distinguished from disease-related conditions. To 
ensure consistency of AE and SAE causality assessments, Investigators should apply the 
following general guideline: 
Not Related: The AE has an etiology other than the study drug (e.g. preexisting medical 
condition, underlying disease, intercurrent illness, or concomitant medication); and/or the AE 
has no plausible temporal relationship to administration of the study drug (e.g. cancer 
diagnosed 2 days after first dose of study drug).  
Possibly Related: There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of the trial medication). However, 
other factors may have contributed to the event (e.g., the participant’s clinical condition, 

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other concomitant events). Although an AE may rate only as “possibly related” soon after 
discovery, it can be flagged as requiring more information and later be upgraded to “probably 
related” or “definitely related”, as appropriate. 
Probably Related: There is evidence to suggest a causal relationship, and the influence of 
other factors is unlikely. The clinical event, including an abnormal laboratory test result, 
occurs within a reasonable time after administration of the study intervention, is unlikely to 
be attributed to concurrent disease or other drugs or chemicals, and follows a clinically 
reasonable response on withdrawal (dechallenge). Rechallenge information is not required to 
fulfill this definition. 
Definitely Related: There is a definite temporal relationship between the onset of the AE 
and administration of the investigational product, and the AE cannot be readily explained by 
the subject’s clinical state, intercurrent illness, or concomitant therapies; and/or the AE 
follows a known pattern of response to the investigational product; and/or the AE abates or 
resolves upon discontinuation of the investigational product or dose reduction and, if 
applicable, reappears upon rechallenge. 
Note: The Investigator’s assessment of causality for individual AE reports is part of the study 
documentation process and will be recorded in the subject’s medical record, AE CRF, and 
SAE form if applicable. AEs recorded without the Investigator’s assessment of the 
relationship to study drug will be followed up until causality is assigned. 
10.3.3 
Assessment of the Outcome of Adverse Events 
Recovered/resolved: The subject has fully recovered from the event, with no residual effects 
observable. 
Recovered/resolved with sequelae: The subject has recovered from the event, but with 
residual sequelae effects observable. 
Not recovered/resolved: Effects of the event are still present. 
Recovering/resolving: The subject has improved, but has not fully recovered from the event. 
Fatal: The death is related to the event. 
Unknown: The outcome of the event is unknown to the reporter (e.g. subject was lost to 
follow-up). 
10.4 
Reporting of Adverse Events 
The Investigator is responsible for ensuring that all AEs and SAEs are recorded in the source 
document, AE CRF, and/or SAE form, and reported to the Sponsor in accordance with 
protocol instructions.  

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10.4.1 
Adverse Event Reporting Period 
All significant medical conditions including signs/symptoms of the underlying diagnosis 
found during the screening period and up to randomization will be captured as medical 
history. Any event/condition related to participation in the trial but not related to underlying 
or concomitant disease that is noted after screening up to the randomization date will be 
captured as a non-treatment emergent AE. 
Any event/condition noted once the subject is randomized will be captured as an AE. 
All AEs and SAEs regardless of attribution will be collected until at least 30 days following 
the last administration of study treatment. At the last scheduled visit, the Investigator should 
instruct each subject to report to the Investigator any subsequent SAEs that the subject’s 
personal physician believes could be related to prior study treatment. Any related non-serious 
AE occurring after the reporting period may be reported at the discretion of the Investigator. 
AEs and SAEs related to study drug that persist > 30 days after the last study drug dose 
should be followed until resolution or until they return to baseline, stabilize, the subject is 
lost to follow-up, or it has been determined that the study treatment or participation is not the 
cause of the AE/SAE. Resolution of AEs and SAEs (with dates) should be documented on 
the AE CRF and SAE form (if applicable) and in the subject’s medical record to facilitate 
source data verification. For some SAEs, the Sponsor or its designee may follow up by 
telephone, facsimile, electronic mail, and/or a monitoring visit to obtain additional case 
details deemed necessary to appropriately evaluate the SAE report (e.g. hospital discharge 
summary, consultant report, or autopsy report).  
10.4.2 
Eliciting Adverse Events 
A consistent methodology of non-directive questioning for eliciting AEs at all subject 
evaluation time points should be adopted. Examples of non-directive questions include: 
“How have you felt since your last clinic visit?” 
“Have you had any new or changed health problems since you were last here?” 
10.4.3 
Recording Adverse and Serious Adverse Events  
Investigators should use correct medical terminology/concepts when recording AEs or SAEs 
on the CRF and/or SAE form. Colloquialisms and abbreviations should be avoided. SAEs 
must also be recorded on the AE CRF. Only one medical concept should be recorded in the 
event field on the AE CRF and SAE form (if applicable). 
a. 
Signs and Symptoms versus Diagnosis 
Signs and symptoms should be recorded on the AE CRF rather than the unifying diagnosis. 
The unifying event term or diagnosis should be recorded as the “etiology” in the CRF (if 
known), and the SAE form, if applicable. For example, jaundice, asterixis, and elevated 
transaminases should be recorded on the CRF, and “liver failure” should be recorded as the 
etiology. As another example, cough, rhinitis, and sneezing should be recorded as AEs on the 

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CRF, and record “upper respiratory tract infection” as the etiology. Vague, nonspecific AE 
terms such as “erythema,” “rash,” or “lump on head” should be avoided and more specific 
information should be provided, such as “erythematous macule on right leg.” “allergic 
dermatitis,” and “scalp cyst.” 
b. Adverse Events Occurring Secondary to Other Events 
In general, AEs occurring secondary to other events (e.g. cascade events or clinical sequelae) 
should also be entered as separate AEs. For example, if severe diarrhea is known to have 
resulted in dehydration, both diarrhea and dehydration should be entered as AEs on the CRF, 
and if also serious, on the SAE form.  
c. 
Persistent or Recurrent Adverse Events 
A persistent AE is one that extends continuously, without resolution between subject 
evaluation time points. Such events should only be recorded once in the CRF unless their 
severity increases. If a persistent AE becomes more severe or occurs more frequently, 
it should be recorded again on the AE CRF with the increased severity grading.  
A recurrent AE is one that occurs and resolves between subject evaluation time points and 
subsequently recurs. All recurrent AEs should be recorded individually on the AE CRF. 
d. Abnormal Laboratory Values 
Only clinically significant laboratory abnormalities that require active management will be 
recorded as AEs on the CRF and SAE form (if applicable). For example, abnormalities that 
require study drug dose modification, discontinuation of study treatment, more frequent 
follow-up assessments, further diagnostic investigation, etc.  
If the laboratory abnormality can be characterized by a precise clinical term, the clinical term 
should be recorded as the AE or SAE. For example, an elevated serum potassium level of 
7.0 mEq/L should be recorded as “hyperkalemia.” 
Observations of the same clinically significant laboratory abnormality from visit to visit 
should not be repeatedly recorded as AEs on the CRF and SAE form (if applicable), unless 
their severity, seriousness, or etiology changes.  
e. 
Deaths 
All deaths that occur during the protocol-specified AE reporting period (see Section 10.4.1), 
regardless of attribution, will be recorded on the AE CRF and SAE form and reported to the 
Sponsor within 24 hours of event knowledge.  
When recording a death, the event or condition that caused or contributed to the fatal 
outcome should be recorded as a single medical concept. For example, if death resulted from 
respiratory failure, the AE recorded should be “Respiratory Failure”, and the Outcome of the 
AE would be “Death”. If the cause of death is unknown and cannot be ascertained at the time 
of reporting, record “unexplained death” on the AE CRF and SAE form. 

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f. 
Preexisting Medical Conditions 
A preexisting medical condition is one that is present at the start of the study. Such 
conditions should be recorded on the Medical and Surgical History CRF. 
A preexisting medical condition should be recorded as an AE or SAE only if the frequency, 
severity, or character of the condition worsens during the study. When recording such events 
on an AE CRF and SAE form (if applicable), it is important to convey the concept that the 
preexisting condition has changed by including applicable descriptors (e.g. “more frequent 
headaches”). 
g. 
Pulmonary Exacerbation  
Given the proposed mechanism of action of AP-PA02, it could be anticipated that subjects 
will experience a change in baseline cough, change in sputum quality, or change in sputum 
volume. A diagnosis of pulmonary exacerbation should be considered if these symptoms are 
accompanied by fever, body weight loss, and/or generalized malaise. COVID-19 disease or 
other infections should also be strongly considered and evaluated by testing at the discretion 
of the treating physician. If a pulmonary exacerbation is diagnosed, appropriate interventions 
including additional antibiotics should be prescribed by the Investigator or treating physician. 
Subjects diagnosed with a pulmonary exacerbation requiring the addition of antibiotics will 
be discontinued from study drug, but will continue to be followed for safety through the End 
of Study visit. 
h. Hospitalization, Prolonged Hospitalization or Surgery 
Any AE that results in hospitalization or prolonged hospitalization should be documented 
and reported as an SAE unless specifically instructed otherwise in this protocol.  
i. 
Pregnancy 
Abortion, whether therapeutic, or spontaneous, will be reported on a Pregnancy Report form 
and faxed to the Sponsor according to the instructions in the Study Manual. If the abortion 
meets seriousness criteria (see Section 10.5, Serious Adverse Event Definition), this 
information will be captured on the AE CRF and SAE form. 
Any congenital anomaly/birth defect in a child born to a female subject or to a female partner 
of a male subject exposed to the investigational product should be recorded and reported as 
an SAE.  
If a female subject becomes pregnant while still scheduled to receive additional study drug 
doses, study drug should be discontinued, and should remain in the study for safety follow-up 
through the End of Study Visit, in addition to the required pregnancy follow-up as described 
above. 
If a female partner of a male study subject becomes pregnant while her partner is receiving 
study drug, or within 30 days following the last dose of study drug, a Partner Pregnancy 
Report form should be completed and submitted to the Sponsor’s Drug Safety Department 
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(or designee) within 24 hours of learning of the pregnancy (see Study Manual for reporting 
instructions).  
j. 
Overdose Reporting 
Overdoses must be reported to the Sponsor on an AE CRF and an SAE form for tracking 
purposes and will be considered a protocol violation. Overdose is defined as any study drug 
dose administered above the intended dose for the cohort assignment. Additional instructions 
for reporting overdose information will be provided by the Sponsor at the time of 
notification. 
10.5 
Serious Adverse Events 
10.5.1 
Definition 
An SAE is any AE that suggests a significant hazard, contraindication, side effect, or 
precaution regardless of the relationship to study drug. An SAE is any AE that results in any 
of the following outcomes:  
- 
Death 
- 
Life-threatening AE. This definition implies that the subject, in the view of the 
Investigator, is at immediate risk of death from the event as it occurred. It does 
not include an event that, had it occurred in a more severe form, might have caused 
death. 
- 
Subject hospitalization or prolonged existing hospitalization 
- 
Persistent or significant disability/incapacity (ie, the AE results in substantial 
disruption of the subject’s ability to conduct normal life functions) 
- 
Congenital anomaly or birth defect. This serious criterion applies if a congenital 
anomaly/birth defect is diagnosed in a child born to a female subject, or a female 
partner of a male subject exposed to the investigational product. 
- 
Other important medical events. Medical and scientific judgment should determine 
whether an AE should be classified as serious in other situations, such as important 
medical events that may not be immediately life-threatening or result in death or 
hospitalization, but may jeopardize the subject or require intervention to prevent one 
of the outcomes listed in the definition above. Examples of such events include 
allergic bronchospasm requiring intensive treatment in an emergency room or at 
home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, 
or the development of drug dependence or abuse. 
 
All AEs that do not meet any of the criteria for serious should be regarded as non-serious 
AEs. 
The terms “severe” and “serious” are not synonymous. Severity refers to the intensity of an 
AE (as in mild, moderate, or severe pain); the event itself may be of relatively minor medical 

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significance (such as severe headache). “Serious” is a regulatory definition and is based on 
subject or event outcome or action criteria usually associated with events that pose a threat to 
a subject’s life or vital functions. Seriousness (not severity) serves as the guide for defining 
regulatory reporting obligations. 
Severity and seriousness should be independently assessed when recording AEs and SAEs on 
the CRF and SAE form. 
10.6 
Suspected Unexpected Serious Adverse Reaction Definition (SUSAR) 
A SUSAR is a suspected unexpected serious adverse reaction. In order to be qualified as a 
SUSAR, the AE must meet 3 criteria: the event is serious, there is a certain degree of 
probability that the event is a reaction to the medical product being researched, and the nature 
and severity of the reaction are not in agreement with the product information (ie, the 
reaction is unexpected as per the reference safety information).  
10.7 
Serious Adverse Events Notification  
For all SAEs, regardless of suspected causality, an SAE form must be completed (or faxed if 
using paper form) within 24 hours of discovery of the event. Instructions for the reporting of 
safety events are outlined in the Study Manual. 
Any fatal or life-threatening (ie, imminent risk of death) event that is attributed by the 
Investigator to the investigational product must be telephoned to Drug Safety immediately, 
followed by submission of written case details on an SAE form within 24 hours. 
SAEs occurring any time after study participation that are considered by the Investigator to 
be possibly related to study drug must also be reported. The following are important points to 
remember when completing the SAE form: 
- 
If complete information is not available, at a minimum, subject identifier, suspect 
drug, site identifier, event or outcome, and Investigator assessment of causal 
relationship to study drug should be provided. 
- 
A rationale for the causality assessment of an SAE should always be included, so that 
a better understanding of the event can be compiled. 
- 
Follow-up information, such as laboratory reports, discharge summaries, autopsy 
reports, and information concerning outcome of the event should be submitted by 
revising the SAE form as soon as the information becomes available. Copies of 
source documents with subject identifiers redacted should be submitted only when 
they are written in English. If source documents are not in English, the Investigator 
must summarize the source documents, providing a complete English narrative that 
includes a description of the events as it evolved, the results of all diagnostic 
procedures performed, treatments administered, and outcome of the event. A query 
regarding a follow-up report should be answered within 5 working days from receipt 
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- 
Appropriate diagnostic tests and therapeutic measures are to be performed as 
necessary and reported on the SAE form. 
- 
All SAEs must be reported to the IRB/IEC, if applicable. See ICH GCP E6(R2), 
Section 4.11.1. 
 
10.8 
Expedited Reporting of SUSARs 
- 
The Sponsor or its designee is responsible for notifying the investigational sites of all 
expedited SAEs (ie, 7/15 Day SUSARs) that occur during any clinical studies that are 
using the investigative compound. The Sponsor or its designee shall also notify the 
Central IRB of SUSARs or significant risks to subjects, per FDA requirements.  
- 
The Investigator will notify local IRB or Local Ethics Committees (LECs) of 
SUSARs or significant risks to subjects, per local country requirements. The 
Investigator must keep copies of all AE information, including correspondence with 
the Sponsor or Local Ethics Committees on file.  
- 
The Sponsor will also notify FDA of SUSARs as per 21 CFR 312.32. 
 
10.9 
Emergency Unblinding Procedure 
In the event of a medical emergency, when knowledge of treatment assignment is needed for 
immediate medical management of the subject’s health, Investigators can obtain unblinded 
treatment assignment through the centralized Interactive Response Technology (IRT) system 
at any time. Thorough documentation of the rationale for unblinding is required. Consultation 
of the study Medical Monitor and/or Sponsor designee is recommended for all unblinding 
requests. 

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11 
STATISTICAL METHODOLOGY 
11.1 
General Considerations 
A comprehensive Statistical Analysis Plan (SAP) specifying the statistical methodology, and 
table, listing and figure (TLF) formats for all aspects of the planned analyses will be finalized 
prior to database lock. The SAP supports the completion of the Clinical Study Report (CSR) 
for this protocol. As the risk profile of AP-PA02 in humans is unknown and this is a first in 
human trial, all AEs will be considered in determining the safety profile of AP-PA02 unless 
obviously unrelated. As an early phase clinical study, exploratory analyses not necessarily 
identified in the SAP may be performed to support the clinical development program. Any 
post-hoc or unplanned analyses not identified in the SAP will be clearly identified in the 
CSR, in accordance with applicable Standard Operating Procedures (SOPs) of the Sponsor or 
designee.  
11.2 
Determination of Sample Size 
This is a Phase 1b/2a safety study designed to evaluate the safety, tolerability and phage titers 
of AP-PA02. The sample size is not based on power calculations; it is chosen based on 
clinical experience and considered to be adequate to fulfill the objectives of the study. 
Eight subjects will be enrolled in the SAD portion of the study, with 4 subjects per cohort 
(3 AP-PA02 and 1 placebo). Approximately 24 subjects will be enrolled in the MAD portion 
of the study, with 4 subjects in Cohort 3 (3 AP-PA02 and 1 placebo) and 20 subjects in 
Cohort 4 (15 AP-PA02 and 5 placebo). The exact number of subjects enrolled is dependent 
on whether any dose level is to be expanded due to the occurrence of DLTs. 
11.3 
Randomization and Blinding 
11.3.1 
Randomization Procedures 
Following successful screening, potential subjects will be randomized through a centralized 
IRT system into the current enrolling cohort. All sites will be capable of and expected to 
enroll all cohorts of the study. Subjects who meet all of the inclusion criteria and none of the 
exclusion criteria will be eligible for randomization. The IRT system will be used to assign 
dose level and treatment assignments to subjects, within the cohort type (SAD or MAD) 
currently open to enrollment.  
11.3.2 
Sentinel Subject Precautions 
Within each SAD dosing cohort, subjects will be randomized 3:1, AP-PA02 to placebo. Due 
to the fact that there are four subjects per SAD cohort, at least one of the first two subjects 
enrolled in each cohort will be randomized to receive AP-PA02. The first two subjects 
enrolled into the same SAD cohort will not be permitted to dose on the same day, to allow 
for adequate review of safety by the study Medical Monitor and/or Sponsor designee 
following dosing, as reported by the Investigator. If there are no significant findings for the 
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first two subjects following their dosing, as reported by the Investigator(s), the remaining 
subjects of the cohort are permitted to undergo study drug dosing.  
Within each MAD dosing cohort, subjects will be randomized 3:1, AP-PA02 to placebo. At 
least one of the first two subjects enrolled in each cohort will be randomized to receive 
AP-PA02. The first two subjects enrolled into the same MAD cohort will not be permitted to 
initiate study drug dosing (Day 1) on the same day, to allow for review of adequate safety by 
the study Medical Monitor and/or Sponsor designee following dosing as reported by the 
Investigator. If there are no significant safety findings for the first two subjects following 
their respective Dosing Day 1 as reported by the Investigator, the remaining subjects are 
permitted to initiate study drug dosing (Day 1). 
11.3.3 
Blinding Procedures 
Study drug will be administered in a double-blind fashion. Study drug and placebo are both 
clear, colorless, and odorless aqueous solutions. Subjects, Investigators and study staff will 
be blinded to treatment assignment. Due to the requirement for study pharmacists to prepare 
the various study drug dilutions depending on the dosing cohort to which a given study 
subject is assigned, the study pharmacist(s) will be unblinded to treatment assignment. 
11.3.4 
Replacement of Subjects 
Subjects who discontinue from the study after randomization without receiving any treatment 
will be replaced. If a subject has received at least one dose of study drug but discontinues the 
trial before receiving the full course of treatment, an additional subject could be added to the 
same treatment/dose to maintain the sample size. Any data collected from subjects who 
discontinue prematurely will be included in analyses as applicable. The decision for 
replacement will be made by the Sponsor based on available data and perceived need for 
additional data.  

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12 
ANALYSIS OF POPULATIONS 
Due to its exploratory nature, the analyses for this study will be descriptive. Data from the 
two parts of the study (SAD and MAD) will be summarized separately unless otherwise 
noted. Data will be summarized by dose groups, and when appropriate, pooled across dose 
groups.  
Summary statistics for continuous data will include the number of subjects with non-missing 
data, mean, standard deviation, minimum, maximum. Additional summary statistics for 
applicable phage titer parameters may include geometric mean, and geometric coefficient of 
variation. For categorical variables, summary statistics will include frequency and 
proportions. Additional summary statistics may be provided for some endpoints as specified 
in the SAP. All data will be listed by subject, dose level and visit, where appropriate.  
Safety Population: the population for safety analyses will consist of all subjects who receive 
any AP-PA02 or placebo. 
Exploratory Efficacy Population: the population for efficacy (clinical activity) analysis will 
consist of all subjects who receive any AP-PA02 or placebo with at least one baseline and 
one post baseline assessment for a specific efficacy endpoint. 
Phage Distribution and Clearance Population: the population for phage distribution analyses 
will consist of all subjects who receive AP-PA02 and who have at least one detectable 
AP-PA02 concentration measurement in sputum, blood or urine samples. 
12.1 
Subject Disposition, Demographics and Baseline Disease Characteristics 
Subject disposition will be summarized for the safety population by dose group.  
The number and percentage of subjects who receive AP-PA02 will be tabulated by the 
number of doses and the AP-PA02 dose group.  
Subject demographics and baseline characteristics will be summarized for each study part 
and dose group. Subject characteristics at baseline include age, sex, race, body weight, 
height, and BMI. Baseline disease characteristics include pulmonary function (percent 
predicted), CFRSD-CRISS, and CFQ-R Respiratory Symptoms Score. The baseline data is 
defined as the data most recently collected prior to the first dose. 
12.2 
Treatment Compliance 
All doses are observed and administered by study staff. Treatment compliance will be 
determined by source records documenting treatment observations and summarized. 

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12.3 
Safety Analyses 
12.3.1 
Treatment Emergent Adverse Events 
A treatment emergent AE (TEAE) is defined as an event that was not present prior to 
administration of the first dose of study drug and present after the first dose or if it represents 
the exacerbation of an event that was present prior to the first dose. 
AEs noted during the study will be coded to system organ classes (SOCs) and preferred 
terms (PTs) using the Medical Dictionary for Regulatory Activities (MedDRA). The overall 
incidence of TEAEs will be summarized by study part, dose group and classified by SOC and 
PT. Deaths, AEs of interest, AE severity, seriousness, relationship to study drug and study 
discontinuation due to AE will also be tabulated by study part and dose group. An AE will be 
considered drug-related if the relationship attribution designation is missing. AEs with 
missing start dates, but with stop dates overlapping into the treatment period will be counted 
as treatment emergent. All AEs will be listed in subject listing, and summarized by numbers 
and percent of subjects by dose for each portion of the study separately. If a subject reports 
the occurrence of a particular event more than once, the most severe of those events will be 
included in the summary tables of TEAEs, and the most severe of the treatment-related 
events will be included in the summary tables of treatment-related events. 
12.3.2 
Dose-Limiting Toxicities 
DLTs will be summarized overall, and by study part and dose group, and severity. Individual 
subject listings will be provided for each DLT including severity and other descriptive 
information such as associated laboratory values and action taken. 
12.3.3 
Vital Signs 
Vital sign measurements will consist of respiratory rate, pulse, blood pressure, temperature 
and oximetry. Descriptive summaries (number of subjects, mean, standard deviation, median, 
minimum, and maximum) of actual values and changes from baseline will be presented for 
each time point. These summaries will be presented for the safety population and by study 
part and dose group. 
12.3.4 
Laboratory Assessments 
Laboratory measurements (hematology, chemistry and urinalysis) obtained at baseline and 
each study visit will be summarized by study part and dose group in the following ways: 
- 
Descriptive statistics of actual results and changes from baseline (number of subjects, 
mean, standard deviation, median, minimum, and maximum) for the continuous data 
and frequencies and percentages for the categorical data, for each assessment visit 
- 
Potentially clinically significant lab abnormalities for hematology, chemistry and 
coagulation will be summarized by study part, dose group and assessment visit.  
- 
If appropriate, by-subject line plots may be presented by lab parameter, study part and 
dose group, to allow for significant out of range values to be further identified. 

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12.3.5 
Immunogenicity  
For subjects with positive anti-AP-PA02 antibodies, the correlation between antibody titer 
and concentration of AP-PA02 in blood and sputum will be examined. Correlation between 
antibody titer and any treatment emergent AEs (TEAEs) will also be examined. 
12.3.6 
Other Safety Assessments 
Other safety assessments, such as ECGs, spirometry, and physical examinations will be 
summarized and listed as specified in the SAP. 
12.4 
Phage Recovery Analyses 
12.4.1 
Phage Recovery Measurements 
In case of SAE or early withdrawal, a blood draw for phage recovery will be collected at or 
near the time the subject reports the SAE, or at the time of withdrawal, if deemed required by 
the Investigator.  
12.4.1.1 
SAD Measurements 
In the SAD portion of the study blood and sputum samples will be obtained from each 
subject for phage recovery analyses. Blood samples will be collected prior to study drug 
administration, at the time points specified in the Schedule of Assessments appendix 
(approximately 5 mL of blood for each sampling time). 
12.4.1.2 
MAD Measurements 
In the MAD portion of the study, blood and sputum samples will be obtained from each 
subject for phage recovery analyses. Blood samples will be collected prior to first study drug 
administration, at the time points specified in the Schedule of Assessments appendix 
(approximately 5 mL of blood for each sampling time). 
12.4.1.3 
Urine Samples 
Urine for phage recovery will be collected prior to first study drug administration, at the time 
points specified in the Schedule of Assessments appendix. 
12.4.2 
Phage Recovery Analysis Methods 
To examine the phage recovery profile of inhaled administrations at the different dose levels 
of AP-PA02, the following parameters will be calculated if sufficient data are available for 
each dose: 
- 
Cmax: The maximum blood concentration will be taken directly from the data. 
- 
tmax: Time to Cmax will be taken directly from the data. 

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- 
t½: The terminal elimination half-life will be estimated by non-linear regression 
analysis of the terminal elimination slope, if feasible. 
- 
AUC0-t: Area under the curve to the final sample with a concentration greater than 
lower limit of quantification (LLQ) will be calculated using the linear trapezoidal 
method. 
- 
AUC0-∞: Area under the curve to infinity will be calculated based on the last observed 
concentration Clast(obs) and the terminal phase rate constant (λz) using formula: 
AUC0-∞=AUClast+Clast(obs)/λz, if feasible. 
- 
CL/F: Blood clearance will be estimated using the formula: CL = Dose/AUC0-∞. 
 
Achievement of steady state of the drug will be determined from trough levels. 
Blood concentration below LLQ prior to dose for the assay will be set to zero for the phage 
titer analysis. For other cases concentrations below LLQ will be set for non-informative 
missing. Exact procedure for imputation of data will be described in the SAP. 
All samples obtained from all cohorts will be analyzed to avoid bias in data presentation. 
Drug concentrations will be summarized by nominal time point if 3 or more values are 
available. Descriptive statistics for phage titer parameters will be performed if the number of 
values to summarize is ≥ 3. 
Geometric means and coefficients of variation will be tabulated for Cmax, AUC0-t, AUC0-∞ 
and Cl for each dose group if possible. Tmax will be summarized by median, minimum and 
maximum. Mean, standard deviation, minimum and maximum will be provided for T½. Exact 
details for statistical analysis of phage concentrations and derived phage titer parameters will 
be presented in the SAP. 
In the case there is not sufficient data available to perform non-parametric analyses of 
exposure, a model-based approach may be applied. In such case, the method of exposure 
quantification will be described in a modeling analysis plan separate from the SAP. 
Correlation between concentrations in different matrices (blood, urine, sputum) and response 
(safety, efficacy) may be explored. 
12.5 
Efficacy Analyses 
The clinical efficacy endpoints for the study will be summarized for subjects included in the 
specific efficacy evaluable population for the parameter, by study part and dose group.  
Change in sputum density of P. aeruginosa from Baseline through approximately 14 days 
after the last study drug dose for the MAD will be summarized as a secondary endpoint. 
Exploratory efficacy endpoints will include: 

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• Change in P. aeruginosa isolates’ sensitivity to AP-PA02 and/or its individual 
components from Screening to approximately 14 days after the last study drug dose 
• Change in Cystic Fibrosis Questionnaire-Revised (CFQ-R) from Day 1 pre-dose through 
end of study 
• Changes in the Cystic Fibrosis Respiratory Symptom Diary (CFRSD) and Chronic 
Respiratory Infection Symptom Score (CRISS) from baseline through the end of the 
study 
 
Observation value and change from baseline value will be summarized using descriptive 
statistics in exploratory endpoints and will be tabulated by study part and dose group.  
Further to the above, change in FEV1 from baseline through end of study will also be 
summarized descriptively by study part and dose group; however as the FEV1 endpoints form 
part of the safety and tolerability criteria, to avoid duplication it will be presented as Safety 
analysis, under the Safety population. See Section 12.3.6 for further details. 
 
12.6 
Interim Analysis 
Safety will be assessed prior to each dose escalation by the SMC, as described in Section 9.1. 
No formal interim analyses for efficacy or futility are planned.  
An interim analysis for phage titer may be performed. Further details regarding the handling 
of any interim phage titer data and analyses will be described in the SAP. Only personnel 
involved in phage titer analyses will be granted access to the unblinded data before database 
lock. No formal interim report will be generated. 
12.7 
Subgroup Analyses 
No subgroup analyses are planned. 

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13 
QUALITY CONTROL AND QUALITY ASSURANCE 
13.1 
Changes to the Protocol 
Sponsor will inform the Investigator in writing of any amendment to the protocol. The 
Investigator must submit the protocol modifications and any informed consent modifications 
to the IRB/IEC and applicable country authorities, and approval must be obtained before the 
modifications are implemented (unless a life-threatening situation). The Investigator must 
send a copy of the approval letter from the IRB/IEC to the designated contract research 
organization (CRO) for Sponsor review. 
Both the Sponsor and the Investigator reserve the right to terminate the study according to 
the study contract. The Investigator should notify the IRB/IEC and applicable country 
authorities in writing of the trial’s completion or early termination and send a copy of the 
notification to the Sponsor. 
13.2 
Data Collection and Study Monitoring 
An electronic CRF (eCRF) will be used for this study. Study site personnel will be trained 
and authorized to use the system in compliance with CFR 21CFR Part 11, ICH GCP and 
local regulations, before recording data on eCRFs. All corrections to eCRFs will be made by 
authorized users, and the changes will be automatically logged in the audit trail of the system 
(time and date stamps and the user entering or updating data). 
eCRFs should be completed for every subject screened or enrolled in the study. Each subject 
will be identified by a unique subject identifier (site number and subject number). At the 
study’s conclusion, a PDF file will be created for each site containing their subjects’ data 
submitted on eCRFs. In the event of an audit or regulatory authority inspection, copies of the 
eCRFs will be printed. 
The Investigator will ensure that the eCRFs are accurate, complete, and completed in a 
timely fashion. The Investigator will ensure that source documents that are required to verify 
the validity and completeness of data transcribed on the eCRFs are never obliterated or 
destroyed. Separate source records are required to support all eCRF entries. The eCRF is not 
to be used to document data without prior written or electronic records. 
To ensure the quality of clinical data across all subjects and sites, a clinical data management 
review will be performed on subject data. During this review, subject data will be checked 
for consistency, omissions, and any apparent discrepancies. In addition, the data will be 
reviewed for adherence to the protocol and GCP. To resolve any questions arising from the 
clinical data management review process, data queries will be sent to the site. Corrections or 
updates to the data resulting from queries should be made on the eCRF. All changes will be 
automatically documented in the software’s audit trail, including the reason for change. 
The Investigator will electronically sign and date the indicated places on the eCRF. These 
signatures will indicate that the Investigator inspected or reviewed the data on the eCRF and 
agrees with the content. 

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A Sponsor representative will contact the Investigator(s) at periodic intervals by telephone or 
visit for the purpose of inspecting the facilities and assessing the progress of the study. CRFs, 
eCRFs, and subject records will be reviewed via central, remote, or on-site monitoring visits 
at regular intervals throughout the study to verify adherence to the protocol; completeness, 
accuracy, and consistency of the data; and adherence to local regulations on the conduct of 
clinical research. The monitor should have access to subject medical records and other study-
related records needed to verify the entries on the CRFs and eCRF while on-site, or via 
secure web portal. 
The Investigator agrees to cooperate with the monitor to ensure that any problems detected in 
the course of these monitoring visits, including delays in completing CRFs/eCRF, are 
resolved. 
Inspection of site facilities (e.g. pharmacy, drug storage areas, laboratories) and review of 
study-related records will occur to evaluate the trial conduct and compliance with the 
protocol, ICH GCP, and applicable regulatory requirements. Study drug dispensing and 
accountability will also be assessed. 

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14 
ETHICAL AND REGULATORY OBLIGATIONS 
14.1 
Ethical Considerations 
The Investigator agrees to conduct this study in accordance with the ICH principles of GCP 
and with the Declaration of Helsinki (October 2013). The Investigator will conduct all 
aspects of this study in accordance with all national, state and local laws of the applicable 
regulatory agencies. 
14.2 
Informed Consent 
Before the start of required study procedures, the Investigator or his/her associate must obtain 
informed consent from each study participant (or the subject’s legal representative) in 
accordance with ICH GCP, the U.S. federal regulations (21 CFR Part 50) and corresponding 
country authority requirements. Separate informed consent may be required for CFTR 
genotyping, CFTR gene sequencing, and/or biomarker testing. The subject or his/her legal 
representative must sign the current version of the written, IRB/IEC-approved informed 
consent form in the presence of a witness and be given a copy. The Investigator will ensure 
that a copy of the signed consent is kept with the subject’s records. 
In accordance with ICH GCP and federal regulations (21 CFR 312.66), an IRB/IEC that 
complies with regulations in 21 CFR Part 56 must review and approve this protocol and the 
informed consent form prior to initiation of the study. The Investigator will submit a list of 
the names, occupations, and affiliations of the members of the IRB/IEC and documentation 
that the IRB/IEC is duly constituted or a General Assurance Number. No supplies will be 
shipped until the IRB/IEC and applicable country authorities have given written approval of 
the protocol and informed consent and the Sponsor has received copies of these approvals.  
The Investigator must submit and, where necessary, obtain approval from the IRB/IEC and 
applicable country authorities for all subsequent protocol amendments and changes to the 
informed consent document. The Investigator should notify the IRB/IEC of deviations from 
the protocol or SAEs occurring at the site. SUSARs and other AE reports will be reported to 
the ECs and applicable country authorities by the Sponsor, in accordance with local 
procedures. 
The Investigator will be responsible for obtaining annual IRB/IEC renewal throughout the 
duration of the study. Copies of the Investigator’s reports and the IRB/IEC continuance of 
approval must be sent to the Sponsor. 
Each U.S. IRB or corresponding regulatory authority participating in this clinical study is 
required to be registered with the U.S. Department of Health and Human Services (HHS) or 
corresponding agency respectively.  
14.3 
Pre-Study Documentation Requirements 
The Investigator is responsible for forwarding the following documents to the CRO for 
Sponsor review before the initial shipment of study drug to the site. 

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• Signed and dated protocol signature page (Investigator’s Agreement) 
• Signed and dated Investigator’s Brochure Acknowledgement of Receipt form 
• Copy of the IRB/IEC –approved informed consent form 
• Copy of the IRB/IEC approval of the protocol 
• Copy of applicable country authority approvals of the protocol 
• Up-to-date curricula vitae of Investigator and all co/sub-investigators listed on Form 
FDA 1572 
• The IRB/EC composition and/or written statement that the IRB/IEC is in compliance 
with regulations 
• Local laboratory normal ranges and documentation of laboratory certification (or 
equivalent) 
• Signed study contract 
• Completed FDA Form 1572 or Investigator Agreement 
• Financial Disclosure Forms for the Investigator and all Sub-Investigators listed on the 
FDA Form 1572 
 
14.4 
Financial Disclosure 
Investigators and sub-investigators will provide the Sponsor with sufficient, accurate 
financial information as requested to allow the Sponsor to submit complete and accurate 
financial certification or disclosure statements to the appropriate regulatory authorities. 
Investigators are responsible for providing information on financial interests during the 
course of the study and for one year after completion of the study. 
14.5 
Subject Confidentiality 
The Investigator must ensure that the subject’s confidentiality is maintained. On the CRFs or 
other documents submitted to the Sponsor, subjects should be identified by their date of birth 
and subject number only. For countries where local regulatory guidelines prohibit capture of 
full date of birth, partial date will be recorded in line with local regulations. Documents that 
are not for submission to the Sponsor (e.g. signed informed consent forms), should be kept in 
strict confidence by the Investigator.  
In compliance with federal and local regulations, it is required that the Investigator and 
institution permit authorized representatives of the Sponsor, the Food and Drug 
Administration, other regulatory authorities, and the IRB/IEC direct access to review the 
subject’s original medical records for verification of study-related procedures and data. 
Direct access includes examining, analyzing, verifying, and reproducing any or all records 

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and reports that are important to the evaluation of this study. The Investigator is obligated to 
inform and obtain the consent of the subject to permit named representatives to have access 
to the study-related records without violating the confidentiality of the subject. 
14.6 
Dissemination of Clinical Study Data  
The Sponsor is responsible for posting appropriate study information on applicable websites 
including the US National Institutes of Health’s website www.clinicaltrials.gov. Information 
included in clinical study registries may include participating investigators’ names and 
contact information. 

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15 
STUDY ADMINISTRATION 
15.1 
Good Clinical Practice and Regulatory Requirements 
This study will be conducted in accordance with good clinical practices as described in the 
ICH E6(R2) GCP, adopted 9 November 2016, and in accordance with CFR Parts 50, 56, 312, 
and 314. The ICH guideline may be obtained at the ICH web site: 
https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf 
15.2 
Investigator’s Brochure 
Before the study begins, the Investigator will receive the AP-PA02 Investigator’s Brochure 
describing all known contraindications, warnings, precautions, and adverse reactions 
associated with the administration of the study drug. If such information is revised while the 
study is in progress, the brochure will be amended or revised, and the Sponsor will provide 
the most current version to the Investigator. 
15.3 
Protocol Amendments and Study Termination 
Protocol amendments must be made only with the prior approval of Sponsor. Sponsor will 
inform the Investigator in writing of any amendment to the protocol. The Investigator must 
submit the protocol modifications and any informed consent modifications to the IRB/IEC, 
and approval must be obtained before the modifications are implemented. The Investigator 
must send a copy of the approval letter from the IRB/IEC to the CRO for Sponsor to review. 
Both the Sponsor and the Investigator reserve the right to terminate the study according to 
the study contract. The Investigator should notify the IRB/IEC in writing of the trial’s 
completion or early termination and send a copy of the notification to the Sponsor. 
15.4 
Study Documentation and Storage 
The Sponsor will provide the Investigator with records of drug shipments, CRFs/eCRFs, and 
other forms as necessary. The Investigator and study staff are responsible for maintaining a 
comprehensive and centralized filing system of all study-related documentation, suitable for 
inspection at any time by representatives from the Sponsor and/or applicable regulatory 
authorities. Elements should include: 
• Subject files containing informed consents and supporting copies of source 
documentation. Any paper CRFs will also be contained in such a file. 
• Study files containing the protocol with all amendments, Investigator’s Brochure, copies 
of prestudy documentation, and all correspondence to and from the IRB/IEC, applicable 
country authorities, and the Sponsor 
• Records of drug disposition and all drug-related correspondence. 
 

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In addition, all original source documents supporting entries in the CRFs/eCRFs must be 
maintained and be readily available for inspection. Upon the request of the Sponsor, 
designees, or the regulatory authorities, the Investigator will make any and all study records 
available for inspection, including subject dairies and source documents. This information 
will be treated as confidential. 
No study document is to be destroyed without prior written agreement between Sponsor and 
the Investigator. Should the Investigator wish to assign the study records to another party or 
move them to another location, he/she must notify the Sponsor in writing of the new 
responsible person and/or the new location. 
15.5 
Use of Information 
All personal information pertaining to the subjects in this study and in any subsequent reports 
will be kept confidential. Subjects will be identified only by their month and year of birth and 
a unique, anonymized subject number. It is the responsibility of the Investigator to keep a 
subject listing for cross-referencing and subject contact information in case of an emergency. 
The Investigator understands that the information developed in the clinical study will be used 
by the Sponsor in connection with the development of the study drug. This information may 
be disclosed to other clinical Investigators, to the U.S. FDA, and to other government 
agencies. 
15.6 
End of Trial and Final Report 
The Investigator or associate must notify the IRB/IEC when the study is closed and must 
provide a final report to the IRB/IEC within 90 days of the last subject’s completion of the 
study. If not initially provided by the Sponsor, a copy of this final report must also be 
provided to Sponsor or its representative.  
15.7 
Financing and Insurance 
Financing and Insurance are addressed separately in the Clinical Trial Agreement. 
15.8 
Publication Policy 
The publications policy is also provided in the Clinical Trial Agreement. The data from this 
study will be available to the Investigators for publication upon the completion of the study. 
The Sponsor agrees to have the results published, whether positive or negative. A publication 
committee will be formed composed of the Investigators. The Sponsor will review any 
manuscripts to ensure that proprietary information has the appropriate patent protection prior 
to journal submission. 
 

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16 
REFERENCES 
Abdelkader K, Gerstmans H, Saafan A, Dishisha T, Briers Y. The Preclinical and Clinical 
Progress of Bacteriophages and Their Lytic Enzymes: The Parts are Easier than the Whole. 
Viruses. 2019;11(2). 
Barbu EM, Cady KC, Hubby B. Phage Therapy in the Era of Synthetic Biology. Cold Spring 
Harb Perspect Biol. 2016;8(10). 
Bertozzi Silva J, Storms Z, Sauvageau D. Host receptors for bacteriophage adsorption. FEMS 
Microbiol Lett. 2016;363(4). 
Bouet JY, Campo NJ, Krisch HM, Louarn JM. The effects on Escherichia coli of expression 
of the cloned bacteriophage T4 nucleoid disruption (ndd) gene. Mol Microbiol. 
1996;20(3):519-528. 
Bragg R, van der Westhuizen W, Lee JY, Coetsee E, Boucher C. Bacteriophages as potential 
treatment option for antibiotic resistant bacteria. Adv Exp Med Biol. 2014;807:97-110. 
Cahill J, Young R. Phage Lysis: Multiple Genes for Multiple Barriers. Adv Virus Res. 
2019;103:33-70. 
Carrigy NB, Chang RY, Leung SSY, et al. Anti-Tuberculosis Bacteriophage D29 Delivery 
with a Vibrating Mesh Nebulizer, Jet Nebulizer, and Soft Mist Inhaler. Pharm Res. 
2017;34(10):2084-2096. 
Chan BK, Turner PE, Kim S, Mojibian HR, Elefteriades JA, Narayan D. Phage treatment of 
an aortic graft infected with. Evol Med Public Health. 2018;2018(1):60-66. 
Cieplak T, Soffer N, Sulakvelidze A, Nielsen DS. A bacteriophage cocktail targeting 
Escherichia coli reduces E. coli in simulated gut conditions, while preserving a non-targeted 
representative commensal normal microbiota. Gut Microbes. 2018;9(5):391-399. 
Clokie MR, Millard AD, Letarov AV, Heaphy S. Phages in nature. Bacteriophage. 
2011;1(1):31-45. 
Conway SP. Evidence for using nebulised antibiotics in cystic fibrosis. Arch Dis Child. 
1999;80(4):307-309. 
Courtney JM, Bradley J, Mccaughan J, et al. Predictors of mortality in adults with cystic 
fibrosis. Pediatr Pulmonol. 2007;42(6):525-532. 
Cystic Fibrosis Foundation. Cystic Fibrosis Foundation Patient Registry 2018 Annual Data 
Report. Bethesda (MD): Cystic Fibrosis Foundation; 2019. 
Dedrick RM, Guerrero-Bustamante CA, Garlena RA, et al. Engineered bacteriophages for 
treatment of a patient with a disseminated drug-resistant Mycobacterium abscessus. Nat Med. 
2019;25(5):730-733. 

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Version Number: 6.0 
Protocol Number: AP-PA02-101 
 
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Page 90 of 115 
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Denou E, Bruttin A, Barretto C, Ngom-Bru C, Brüssow H, Zuber S. T4 phages against 
Escherichia coli diarrhea: potential and problems. Virology. 2009;388(1):21-30. 
d'Herelle F. An address on bacteriophagy and recovery from infectious diseases. Can Med 
Assoc J. 1931;24:619-628. 
Dissanayake U, Ukhanova M, Moye ZD, Sulakvelidze A, Mai V. Bacteriophages Reduce 
Pathogenic. Front Microbiol. 2019;10:1984. 
Graham B, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, et al. 
Standardization of spirometry 2019 update. Am J Respir Crit Care Med 2019; 200(8):e70–
e88. 
Goss CH, Edwards TC, Ramsey BW, Aitken ML, Patrick DL. Patient-reported respiratory 
symptoms in cystic fibrosis. J Cyst Fibros 2009; 8: 245-252. 
Hisert KB, Heltshe SL, Pope C, et al. Restoring cystic fibrosis transmembrane conductance 
regulator function reduces airway bacteria and inflammation in people with cystic fibrosis 
and chronic lung infections. Am J Respir Crit Care Med. 2017; 195(12):1617-1628. 
Kerem E, Viviani L, Zolin A, et al. Factors associated with FEV1 decline in cystic fibrosis: 
analysis of the ECFS patient registry. Eur Respir J. 2014;43(1):125-133. 
Kortright KE, Chan BK, Koff JL, Turner PE. Phage Therapy: A Renewed Approach to 
Combat Antibiotic-Resistant Bacteria. Cell Host Microbe. 2019 Feb 13;25(2):219-232. 
Kutateladze M and Adamia R. Trends in Biotechnology. 2010;28(12):591-595. 
Law N, Logan C, Yung G, et al. Successful adjunctive use of bacteriophage therapy for 
treatment of multidrug-resistant Pseudomonas aeruginosa infection in a cystic fibrosis 
patient. Infection. 2019;47(4):665-668. 
Maddocks S, Fabijan AP, Ho J, et al. Bacteriophage Therapy of Ventilator-associated 
Pneumonia and Empyema Caused by. Am J Respir Crit Care Med. 2019;200(9):1179-1181. 
Mall MA, Hartl D. CFTR: cystic fibrosis and beyond. Eur Respir J. 2014;44(4):1042-1054. 
Mayer-Hamblett N, Kloster M, Rosenfeld M, et al. Impact of Sustained Eradication of New 
Pseudomonas aeruginosa Infection on Long-term Outcomes in Cystic Fibrosis. Clin Infect 
Dis. 2015;61(5):707-715. 
Miller MR, Crapo RO, Hankinson J, Brusasco V, Burgos F, Casaburi R, et al. General 
Considerations for lung function testing. In: Brusasco V, Crapo R, Viegi G, editors. 
ATS/ERS Task Force: Standardisation of lung function testing. Eur Respir J 2005; 26: 153–
161. 

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Version Number: 6.0 
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Mogayzel PJ, Naureckas ET, Robinson KA, et al. Cystic fibrosis pulmonary guidelines. 
Chronic medications for maintenance of lung health. Am J Respir Crit Care Med. 
2013;187(7):680-689. 
Nichols DP, Durmowicz AG, Field A, Flume PA, VanDevanter DR, Mayer-Hamblett N. 
Developing Inhaled Antibiotics in Cystic Fibrosis: Current Challenges and Opportunities. 
Ann Am Thorac Soc. 2019;16(5):534-539. 
Parasion S, Kwiatek M, Gryko R, Mizak L, Malm A. Bacteriophages as an alternative 
strategy for fighting biofilm development. Pol J Microbiol. 2014;63(2):137-145. 
Parkins MD, Rendall JC, Elborn JS. Incidence and risk factors for pulmonary exacerbation 
treatment failures in patients with cystic fibrosis chronically infected with Pseudomonas 
aeruginosa. Chest. 2012;141(2):485-493. 
Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, et al. Interpretative 
strategies for lung function tests. In: Brusasco V, Crapo R, Viegi G, editors. ATS/ERS Task 
Force: Standardisation of lung function testing. Eur Respir J 2005; 26: 948–968. 
Pettit RS, Fellner C. CFTR Modulators for the Treatment of Cystic Fibrosis. P T. 
2014;39(7):500-511. 
Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, et al. Multi-ethnic reference 
values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur 
Respir J 2012; 40: 1324–1343. 
Quittner AL, Buu A, Messer MA, Modi AC, Watrous M. Development and validation of the 
cystic fibrosis questionnaire (CFQ) in the United States: A health-related quality-of-life measure 
for cystic fibrosis. Chest 2005, 128(4): 2347-2354. 
Ramsey BW, Dorkin HL, Eisenberg JD, et al. Efficacy of aerosolized tobramycin in patients 
with cystic fibrosis. N Engl J Med. 1993;328(24):1740-1746. 
Sawicki GS, Signorovitch JE, Zhang J, et al. Reduced mortality in cystic fibrosis patients 
treated with tobramycin inhalation solution. Pediatr Pulmonol. 2012;47(1):44-52. 
Schooley RT, Biswas B, Gill JJ, et al. Development and Use of Personalized Bacteriophage-
Based Therapeutic Cocktails To Treat a Patient with a Disseminated Resistant Acinetobacter 
baumannii Infection. Antimicrob Agents Chemother. 2017;61(10). 
Smyth AR, Bell SC, Bojcin S, et al. European Cystic Fibrosis Society Standards of Care: 
Best Practice guidelines. J Cyst Fibros. 2014;13 Suppl 1:S23-42. 
Taccetti G, Campana S, Festini F, Mascherini M, Döring G. Early eradication therapy against 
Pseudomonas aeruginosa in cystic fibrosis patients. Eur Respir J. 2005;26(3):458-461. 
Twort F. Further investigations on the nature of ultra-microscopic viruses and their 
cultivation. J Hygeine. 1936;36:204-235. 

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US Department of Health and Human Services. Common Terminology Criteria for Adverse 
Events (CTCAE) Version 5.0. Washington DC: HHS; 2017 Nov. 
US Department of Health and Human Services; Food and Drug Administration; Center for 
Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research 
(CBER).E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for 
Industry. Silver Spring (MD): HHS, FDA, CDER, CBER; 2018 March.  
Van Tassell ML, Angela Daum M, Kim JS, Miller MJ. Creative lysins: Listeria and the 
engineering of antimicrobial enzymes. Curr Opin Biotechnol. 2016;37:88-96. 
Vandenberk B, Vandael E, Robyns T, Vanenberghe J, Garweg C, Foulon V, Ector J, Willems 
R. J Am Heart Assoc. 2016;5:e003264 doi: 10.1161/JAHA.116.003264. 
Wanger J, Clausen JL, Coates A, Pederson OF, Brusasco V, Burgos F, et al. Standardisation 
of the measurement of lung volumes. In: Brusasco V, Crapo R, Viegi G, editors. ATS/ERS 
Task Force: Standardisation of lung function testing. Eur Respir J 2005; 26: 511–522. 
Weigel C, Seitz H. Bacteriophage replication modules. FEMS Microbiol Rev. 
2006;30(3):321-381. 
Young R. Phage lysis: three steps, three choices, one outcome. J Microbiol. 2014;52(3):243-
258. 
 

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17 
APPENDICES 
Appendix 1 
Schedule of Assessments 
 
Table A: Schedule of Procedures Part 1 SAD Cohorts 1 and 2 
 
Table B: Timing of Sample Collection and Procedures on Day 1 for SAD Cohort 
 
Table C: Schedule of Procedures Part 2 MAD Cohort 3 (5 Days of Dosing) 
 
Table D: Timing of Sample Collection and Procedures on Day 1 for MAD Cohort 3 
 
Table E: Timing of Sample Collection and Procedures on Dosing Days 2 through 
Day 5 for MAD Cohort 3 
 
Table F: Schedule of Procedures Part 2 MAD Cohort 4 (10 Days of Dosing) 
 
Table G: Timing of Sample Collection and Procedures on Day 1 for MAD Cohort 4 
 
Table H: Timing of Sample Collection and Procedures on Dosing Days 2-4 and 8-10 
for MAD Cohort 4 
 
Table I: Timing of Sample Collection and Procedures on Dosing Days 5-7 for MAD 
Cohort 4 
Appendix 2 
CFQ-R, Adult Version (English) 
Appendix 3 
CFRSD-CRISS Diary 
 

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APPENDIX 1 
SCHEDULE OF ASSESSMENTS 
 Table A: Schedule of Procedures Part 1 SAD Cohorts 1 and 2 
Study Visit 
Scr 
BL 
11 
2 
32 
4 
5 
6  
EOS 
Nominal Study Day: 
–35 to –2 
-7 to -1 
1 
2 
3 
8 
15 
29 
Visit Window (±days) 
 
 
- 
- 
+ 3 
±3 
±3 
±3 
Informed Consent Form  
X 
 
 
 
 
 
 
 
Demographics / Medical History 
X 
 
 
 
 
 
 
 
Eligibility Criteria 
X 
X 
X 
 
 
 
 
 
Administer CFQ-R 
 
 
X 
 
 
 
X 
X 
Randomization 
 
X 
 
 
 
 
 
 
Study Drug Administration  
 
 
X 
 
 
 
 
 
Concomitant Medications Review 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Events Assessment 
 
X 
X 
X 
X 
X 
X 
X 
Physical Examination3 
Full 
Full 
SD 
SD 
SD 
SD 
Full 
SD 
Height and Weight 
H/W 
W 
 
 
 
 
W 
W 
Vital Sign Measurements & Oximetry 
(Temp, BP, RR, HR, SpO2)4 
X 
X 
X 
X 
X 
X 
X 
X 
Spirometry (FEV1, FVC, FEF25-75)5 
X 
X 
X1 
X 
X 
X 
X 
X 
12-lead ECG 
X 
 
X1 
 
 
 
 
 
CFTR Genotyping or Sweat Chloride6 
X  
 
 
 
 
 
 
 
Pregnancy Test for females of childbearing potential 
X 
X 
 
 
 
 
 
X 
Daily Symptom Diary (CFRSD) 
 
dispense 
review 
review 
review 
review 
review 
collect 
 
1 Close safety monitoring will be performed on Day 1 pre and post dose at the following timepoints (refer to Table B regarding safety monitoring timepoints and 
sample collection on Day 1): Vital signs and oximetry will be measured at 10, 30 and 60 minutes, and at 2, 4, and 7 hours post dose; 12-lead ECG at 60 
minutes post dose; spirometry at 30 minutes, 60 minutes and 7 hours post dose. 
2 Study Visit 3 = 48-144 hours post first dose 
3 Physical Exam: Full exams performed at Screening, Baseline (BL) and Day 15. Symptom-directed (SD) exams performed at all other visits. 
4 Vital signs: Oral Body Temperature (Temp), Blood Pressure (BP), Respiratory Rate (RR), Heart Rate (HR), Oxygen saturation by digital oximetry (SpO2) 
5 Spirometry to be performed prior to sputum induction at Screening, BL, and Visits 4 and 5 
6 If no historical CFTR genotyping or sweat chloride result available 

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 Table A: Schedule of Procedures Part 1 SAD Cohorts 1 and 2 
Study Visit 
Scr 
BL 
11 
2 
32 
4 
5 
6  
EOS 
Nominal Study Day: 
–35 to –2 
-7 to -1 
1 
2 
3 
8 
15 
29 
Visit Window (±days) 
 
 
- 
- 
+ 3 
±3 
±3 
±3 
Safety Labs Sample Collection7: 
 
 
 
 
 
 
 
 
 
Blood for Hematology/Chemistries 
X 
X 
 
X 
X 
X 
X 
 
 
Blood for Coagulation 
X 
 
 
 
 
 
 
 
 
Urine for Urinalysis 
X 
X 
 
X 
 
 
X 
 
Sputum for Microbiology: 
 
 
 
 
 
 
 
 
 
Induced Sputum Sample Required8 
* 
* 
* 
* 
* 
 
* 
 
 
Quantitative Culture of P. aeruginosa 
X 
X 
 
X 
X 
 
X 
 
 
Antipseudomonal Antibiotic Sensitivity of Pa 
Isolates 
X 
X 
 
 
 
 
X 
 
 
Phage Sensitivity of Pa Isolates 
X 
 
 
 
 
 
X 
 
 
Expectorated Sputum Sample9 
 
 
* 
* 
* 
* 
 
 
 
Sputum for Quantitative Culture of P. aeruginosa 
 
 
X10 
X 
X 
X 
 
 
Phage Titer/ADA Sampling11: 
 
 
 
 
 
 
 
 
 
Blood for phage titer 
 
X 
X 
X 
 
 
 
 
 
Sputum for phage titer12 
 
X 
X 
X 
X 
X 
X 
 
 
Serum for AP-PA02 ADA & SARS-CoV2 
 
X 
 
 
 
 
X 
X 
 
Urine samples for phage clearance 
 
X 
 
X 
 
 
X 
 
 
7 Samples for clinical lab testing to be analyzed at the site local laboratory 
8 Sputum induction to be performed LAST at Screening, BL, Visits 2, 3 and 5 
9 Expectorated sputum samples to be collected by the subject at home prior to the study visit are requested in addition to the samples collected in the clinic, for 
subjects who are able to expectorate. 
10 For subjects who are able to expectorate, sample to be obtained pre-dose on Day 1. Sample may be collected by the subject at home prior to the study visit or 
collected in the clinic. 
11 See Appendix Table B for various timepoints for sample collection on Day 1 
12 Performed on induced and expectorated sputum sample (if available) (performed at central laboratory). Samples for phage titer to be transported in separate 
collection vessels for each time point and collection method. 

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Table B: Timing of Sample Collection and Procedures on Day 1 for SAD Cohorts 
Test/Procedure 
Pre-
Dose 
Dose 
Admin 
 Nominal Time Post Dose  
 
 
Time 0 
10 min 
15 min 
30 min 
45 min 
60 min 
2 hr 
4 hr 
7 hr 
Study Drug Administration 
 
X 
 
 
 
 
 
 
 
 
Spirometry 
X 
 
 
 
X 
 
X13 
 
 
X 
Vital Signs & Oximetry 
X 
 
X 
 
X 
 
X 
X 
X 
X 
12-lead ECG 
X 
 
 
 
 
 
X 
 
 
 
Blood & Urine for Safety Labs14  
X 
 
 
 
 
 
 
 
 
 
Sputum for Microbiology: 
 
 
 
 
 
 
 
 
 
 
 Expectorated Sputum for Quantitative Culture of P. 
aeruginosa 
X15 
 
 
 
 
 
 
 
 
 
Phage Titer/ADA Sampling 
 
 
 
 
 
 
 
 
 
 
 
Blood for Phage Titer 
 
 
 
X 
 
X 
 
X 
 
X 
 
Induced Sputum for Phage Titer 
 
 
 
 
 
 
 
X16 
 
 
 
Expectorated Sputum for Phage Titer17 
X 
 
X18 
 
X19 
 
 
 
13 Spirometry to be measured after vital signs/oximetry and 12-lead ECG assessments 
14 Samples for clinical lab testing obtained pre-dose on Day 1, if abnormal and clinically significant at Baseline (BL) and results reviewed by Investigator prior to 
administration of study drug; To be analyzed at the site local laboratory 
15 For subjects who are able to expectorate, sample to be obtained pre-dose on Day 1. Sample may be collected by the subject at home on Day 1 prior to the study 
visit or collected in the clinic.  
16 Induced sputum to be collected after vital signs/oximetry measurements and blood collection at the 2 hour time point 
17 Expectorated sputum for phage titer to be obtained as able post-dose on Day 1, performed at central laboratory (above are desired nominal timeframes when 
sputum samples are to be collected. Actual collection times to be recorded in eCRF). 
18 If able to expectorate; optimal sample collection timeframe up to 1 hour post dose 
19 If able to expectorate; optimal sample collection timeframe between 4 and up to approximately 7 hours post dose 

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Schedule of Procedures Part 2 MAD Cohort 3 (5 Days of Dosing) 
Table C: Schedule of Procedures Part 2 MAD Cohort 3 (5 Days of Dosing) 
Study Visit 
Scr 
BL 
1 
2 
3 
4 
5 
EOT 
6 
7 
8 
9 
EOS 
Nominal Study Day 
–35 to –2 
-7 to -1 
1 
2 
3 
4 
5 
6 
12 
19 
33 
Visit Window (±days) 
 
 
- 
- 
- 
- 
- 
+ 3 
± 3 
± 3 
± 3 
Informed Consent Form  
X 
 
 
 
 
 
 
 
 
 
 
Demographics / Medical History 
X 
 
 
 
 
 
 
 
 
 
 
Eligibility Criteria 
X 
X 
X 
 
 
 
 
 
 
 
 
Administer CFQ-R  
 
 
X 
 
 
 
 
 
X 
X 
X 
Pregnancy test for females of childbearing 
potential 
X 
X 
 
 
 
 
 
 
 
 
X 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
Study Drug Administration20  
 
 
X 
X 
X 
X 
X 
 
 
 
 
Concomitant Medications Review 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Events Assessment21 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Physical Examination22 
Full 
Full 
SD 
SD 
SD 
SD 
SD 
SD 
SD 
SD 
Full 
Height and Weight 
H/W 
W 
 
 
 
 
 
 
 
 
W 
Vital Sign measurements & oximetry  
(Temp, BP, RR, HR, SpO2)23 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Spirometry (FEV1, FVC, FEF25-75)24 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
12-Lead ECG 
X 
 
X25 
 
 
 
 
 
 
 
X 
CFTR Genotyping or Sweat Chloride26 
X 
 
 
 
 
 
 
 
 
 
 
Daily Symptom Diary (CFRSD) 
 
dispense 
review 
review 
review 
review 
review 
review 
review 
review 
collect 
 
20 Study drug to be administered twice per day, at least 6 hours apart.  
21 Close safety monitoring will be performed on Dosing Days 1-5 pre and post dose (refer to Tables D and E regarding safety monitoring timepoints and sample 
collection on dosing days). 
22 Physical Exam: Full exams performed at Screening, Baseline (BL), and EOS. Symptom-directed (SD) exams performed at all other visits. 
23 Vital signs: Oral Body Temperature (Temp), Blood Pressure (BP), Respiratory Rate (RR), Heart Rate (HR), Oxygen saturation by digital oximetry (SpO2) 
24 Spirometry to be performed prior to sputum induction at designated visits; Spirometry on dosing days to performed as detailed on Tables D and E 
25 Day 1 12-lead ECG prior to drug administration and 1 hour post dose 
26 If no historical CFTR genotyping or sweat chloride value available 

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Table C: Schedule of Procedures Part 2 MAD Cohort 3 (5 Days of Dosing) 
Study Visit 
Scr 
BL 
1 
2 
3 
4 
5 
EOT 
6 
7 
8 
9 
EOS 
Nominal Study Day 
–35 to –2 
-7 to -1 
1 
2 
3 
4 
5 
6 
12 
19 
33 
Visit Window (±days) 
 
 
- 
- 
- 
- 
- 
+ 3 
± 3 
± 3 
± 3 
Safety Labs Sample Collection27: 
 
 
 
 
 
 
 
 
 
 
 
 
Blood for Hematology/Chemistries 
X 
X 
 
X 
 
 
X 
 
X 
X 
 
 
Blood for Coagulation 
X 
 
 
 
 
 
 
 
 
 
 
 
Urine for Urinalysis 
X 
X 
 
 
 
 
 
X 
 
X 
 
Sputum for Microbiology: 
 
 
 
 
 
 
 
 
 
 
 
 
Induced Sputum Sample Required 28 
* 
* 
* 
* 
* 
* 
* 
* 
* 
* 
* 
 
Quantitative Culture of P. aeruginosa 
X 
X 
 
 
X 
X 
X 
X 
X 
X 
X 
Antipseudomonal Antibiotic Sensitivity 
of Pa Isolates 
X 
X 
 
 
 
 
 
 
 
X 
 
 
Phage Sensitivity of Pa Isolates 
X 
 
 
 
 
 
 
 
 
X 
 
 
Expectorated Sputum Sample29 
 
 
* 
* 
* 
* 
* 
 
 
 
* 
Quantitative Culture of P. aeruginosa 
 
 
X30 
 
X 
X 
X 
 
 
 
 
Phage Titer31, 32 / ADA Sampling: 
 
 
 
 
 
 
 
 
 
 
 
 
Blood for Phage Titer 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Sputum for Phage Titer33 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 Serum for AP-PA02 ADA & SARS-
CoV2 
 
X 
 
 
 
 
 
 
 
X 
X 
 
Urine Samples for Phage Clearance 
 
X 
 
 
 
 
 
X 
 
X 
 
 
27 Samples for clinical lab testing obtained pre-dose on designated dosing days; Safety lab results from the prior visit to be reviewed as available by Investigator 
prior to administering the next dose of study drug; To be analyzed at the site local laboratory. 
28 Sputum induction to be performed LAST at Screening, BL, Visits 1, 5, and 6-9 (non-dosing days); Visits 2-4 to be performed pre-first dose of the day.  
29 Expectorated sputum samples to be collected by the subject at home prior to the study visits indicated are requested in addition to the sample collected in the 
clinic, for subjects who are able to expectorate. 
30 For subjects who are able to expectorate, sample to be obtained pre-dose on Day 1. Sample may be collected by the subject at home on Day 1 prior to the study 
visit or collected in the clinic. 
31 If phage titer signal detected from samples obtained at End of Study Visit, subjects may be requested to provide additional samples until titer is no longer 
detectable  
32 See Appendix Table D for various timepoints for sample collection on Day 1. Samples for phage titers to be transported in separate collection vessels for each 
time point and collection method. 
33 Pre-dose on dosing days 2-4  

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Table D: Timing of Sample Collection and Procedures on Day 1 for MAD Cohort 3 
Test/Procedure 
Pre-Dose 
Nominal Times Post First Dose 
 
 
Time 
0 
10 
min 
15 
min 
30 
min 
45 
min 
60 
min 
2  
hr 
5 
hr 
6 
hr 
7  
hr 
Study Drug Administration 
 
X 
 
 
 
 
 
 
 
X 
 
Spirometry 
X 
 
 
 
X 
 
 
X 
 
 
X 
Vital Signs & Oximetry34 
X 
 
X 
 
 
 
X 
 
 
X 
X 
12-lead ECG 
X 
 
 
 
 
 
X 
 
 
 
 
Blood & Urine for Safety Labs35  
X 
 
 
 
 
 
 
 
 
 
 
Sputum for Microbiology: 
 
 
 
 
 
 
 
 
 
 
 
 Expectorated Sputum for Quantitative Culture of 
P. aeruginosa 
X36 
 
 
 
 
 
 
 
 
 
 
Phage Titer/ADA Sampling 
 
 
 
 
 
 
 
 
 
 
 
 
Blood for Phage Titer 
 
 
 
X 
 
X 
 
X 
X 
 
X 
       Induced Sputum for Phage Titer 
 
 
 
 
 
 
 
 
 
 
X37 
 
Expectorated Sputum for Phage Titer38 
 
 
X39 
X40 
X41 
 
 
 
34 Vital signs and oximetry to be measured pre-dose, and at the other designated time points post-first dose of the day 
35 Samples for clinical lab testing obtained pre-first dose on Day 1 if abnormal and clinically significant at Baseline (BL), and results reviewed by Investigator 
prior to administration of study drug; To be analyzed at the site local laboratory. 
36 For subjects who are able to expectorate, sample to be obtained pre-dose on Day 1. Sample may be collected by the subject at home in the morning just prior to 
the study visit or collected in the clinic. 
37 Sputum induction to be performed LAST at the timepoint indicated 
38 Expectorated sputum for phage titer to be obtained as able post-dose on Day 1, performed at central laboratory (above are desired nominal timeframes when 
sputum samples are to be collected. Actual collection times to be recorded in eCRF.) 
39 If able to expectorate; optimal sample collection timeframe up to 1 hour post Dose 1 
40 If able to expectorate; optimal sample collection timeframe between 2 and 4 hours post Dose 1 (single spot sample, not cumulative during this time period) 
41 If able to expectorate; optimal sample collection timeframe within 1 hour prior to Dose 2 (single spot sample, do not combine with 2-4 hour sample) 

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Table E: Timing of Sample Collection and Procedures on Dosing Days 2 through Day 5 for MAD Cohort 3 
Test/Procedure 
Pre-First 
Dose 
Nominal Times Post First Dose 
 
 
Time 0 
10 min 
15 min 
30 min 
45 min 
60 min 
2 hr 
5 hr 
6 hr 
7 hr 
Study Drug Administration 
 
X 
 
 
 
 
 
 
 
X 
 
Spirometry 
X 
 
 
 
X 
 
 
 
 
 
X 
Vital Signs & Oximetry42 
X 
 
X 
 
 
 
X 
 
 
X 
X 
Blood for Safety Labs43  
X 
 
 
 
 
 
 
 
 
 
 
Phage Titer 
 
 
 
 
 
 
 
 
 
 
 
 
Blood for Phage Titer 
X 
 
 
X44 
 
X44 
 
X44 
X44 
 
X44 
 
Expectorated Sputum for Phage Titer 
X45 
 
 
 
 
 
 
X46 
X47 
 
 
 
Induced Sputum for Phage Titer 
X48 
 
 
 
 
 
 
 
 
 
X49 
 
42 Vital signs and oximetry to be measured prior to each dose on Days 2 through 5, and at the other designated time points post-first dose of the day  
43 Samples for clinical lab testing obtained pre-first dose on Days 2 and 5 only; Safety labs results from the prior visit to be reviewed as available by Investigator 
prior to administration of study drug; To be analyzed at the site local laboratory. 
44 Blood for phage titer to be obtained on Day 5 only. 
45 Expectorated sputum for phage titer to be obtained as able pre-first dose on Days 2 through 5. Sample to be collected by the subject at home in the morning 
just prior to the study visit or in the clinic (if the subject is able to expectorate). 
46 If able to expectorate; optimal sample collection timeframe up to 2 hours post Dose 1 of the day (single spot sample do not combine with 2–4-hour sample). 
47 If able to expectorate; optimal sample collection timeframe between 2 and 4 hours post Dose 1 of the day (single spot sample do not combine during this 
period). 
48 Induced sputum for phage titer to be obtained pre-first dose on Days 2, 3 and 4. 
49 Induced sputum for phage titer to be obtained last on Day 5 only. 

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Schedule of Procedures Part 2 MAD Cohort 4 (10 Days of Dosing) 
Table F: Schedule of Procedures Part 2 MAD Cohort 4 (10 Days of Dosing) 
Study Visit 
Scr 
BL 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
EOT 
11 
12 
13 
14 
EOS 
Nominal Study Day 
–35 to –2 
-7 to -1 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
17 
24 
38 
Visit Window (±days) 
 
 
- 
- 
- 
- 
- 
 
 
 
 
 
 
± 3 
± 3 
± 3 
Informed Consent Form  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Demo / Medical History 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Eligibility Criteria 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Administer CFQ-R  
 
 
X 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
Pregnancy test for females of 
childbearing potential 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Randomization 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study Drug Admin50  
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
Concomitant Meds Review 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Adverse Events Assessment51 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Physical Examination52 
Full 
Full 
SD 
SD 
SD 
SD 
SD 
SD 
SD 
SD 
SD 
SD 
SD 
SD 
SD 
FULL 
Height and Weight 
H/W 
W 
 
 
 
 
 
 
 
 
 
 
 
 
 
W 
Vital Signs & Oximetry 53 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Spirometry (FEV1, FVC, 
FEF25-75)54 
X 
X 
X 
X 
X 
X 
 
 
 
X 
X 
X 
X 
X 
X 
X 
12-Lead ECG 
X 
 
X55 
 
 
 
 
 
 
 
 
 
 
 
 
X 
CFTR Genotyping or Sweat 
Chloride56 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Daily Symptom Diary 
(CFRSD)57 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X  
 
50 Study drug to be administered twice per day, at least 6 hours apart.  
51 Close safety monitoring will be performed on Dosing Days 1-10 pre and post dose (refer to Tables G, H and I regarding safety monitoring timepoints and 
sample collection on dosing days). 
52 Physical Exam: Full exams performed at Screening, Baseline (BL), and EOS. Symptom-directed (SD) exams performed at all other visits. 
53 Vital signs: Oral Body Temperature (Temp), Blood Pressure (BP), Respiratory Rate (RR), Heart Rate (HR), Oxygen saturation by digital oximetry (SpO2) 
54 Spirometry to be performed prior to sputum induction at designated visits; Spirometry on dosing days to performed as detailed on Tables G and H 
55 Day 1 12-lead ECG prior to drug administration and 1 hour post dose 
56 If no historical CFTR genotyping or sweat chloride value available 
57 Dispense at BL, collect and review at each visit 

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Table F: Schedule of Procedures Part 2 MAD Cohort 4 (10 Days of Dosing) 
Study Visit 
Scr 
BL 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
EOT 
11 
12 
13 
14 
EOS 
Nominal Study Day 
–35 to –2 
-7 to -1 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
17 
24 
38 
Visit Window (±days) 
 
 
- 
- 
- 
- 
- 
 
 
 
 
 
 
± 3 
± 3 
± 3 
Safety Labs Collection58: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Blood for Hem/Chem 
X 
X 
 
X 
 
 
 
 
 
 
 
X 
 
X 
X 
 
Blood for Coag 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Urine for Urinalysis 
X 
X 
 
 
 
 
 
 
 
 
 
X 
 
 
X 
 
Sputum for Microbiology: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Induced Sputum Required 59 
* 
* 
* 
* 
* 
* 
 
 
 
* 
* 
* 
* 
* 
* 
* 
Quant Culture of Pa  
X 
X 
 
 
X 
X 
 
 
 
X 
X 
X 
X 
X 
X 
X 
Anti Pa Abx Sensitivity of 
Pa Isolates 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Phage Sensitivity of Pa 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Expectorated Sputum60 
 
 
* 
* 
* 
* 
 
 
 
* 
* 
* 
 
 
 
 
Quant Culture of Pa 
 
 
X61 
X 
X 
X 
 
 
 
X 
X 
X 
 
 
 
 
Phage Titer62, 63 / ADA: 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Blood for Phage Titer 
 
X 
X 
X 
X 
X 
 
 
 
X 
X 
X 
X 
X 
X 
X 
Sputum for Phage Titer64 
 
X 
X 
X 
X 
X 
 
 
 
X 
X 
X 
X 
X 
X 
X 
Serum for AP-PA02 ADA & 
SARS-CoV2 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
Urine Samples for Phage 
Clearance 
 
X 
 
 
 
 
 
 
 
 
 
 
X 
 
X 
 
 
58 Samples for clinical lab testing obtained pre-dose on designated dosing days; Safety lab results from the prior visit to be reviewed as available by Investigator 
prior to administering the next dose of study drug; To be analyzed at the site local laboratory. 
59 Sputum induction to be performed LAST at Screening, BL, Visits 1, 10, and 11-14 (non-dosing days); Sputum induction to be performed pre-first dose of the 
day at Visits 2-4, 8-9.  
60 Expectorated sputum samples to be collected by the subject at home prior to the study visits indicated are requested in addition to the sample collected in the 
clinic, for subjects who are able to expectorate. 
61 For subjects who are able to expectorate, sample to be obtained pre-dose on Day 1. Sample may be collected by the subject at home on Day 1 prior to the study 
visit or collected in the clinic. 
62 If phage titer signal detected from samples obtained at End of Study Visit, subjects may be requested to provide additional samples until titer is no longer 
detectable.  
63 See Appendix Tables G and H for various timepoints for sample collection on dosing days. Samples for phage titers to be transported in separate collection 
vessels for each time point and collection method. 
64 Pre-dose on dosing days 2-4, 8-9 

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Table G: Timing of Sample Collection and Procedures on Day 1 for MAD Cohort 4  
Test/Procedure 
Pre-Dose 
Nominal Times Post First Dose 
 
 
Time 0 
10 min 
15 min 
30 min 
45 min 
60 min 
2 hr 
5 hr 
6 hr 
7 hr 
Study Drug Administration 
 
X 
 
 
 
 
 
 
 
X 
 
Spirometry 
X 
 
 
 
X 
 
 
X 
 
 
X 
Vital Signs & Oximetry65 
X 
 
X 
 
 
 
X 
 
 
X 
X 
12-lead ECG 
X 
 
 
 
 
 
X 
 
 
 
 
Blood & Urine for Safety Labs66  
X 
 
 
 
 
 
 
 
 
 
 
Sputum for Microbiology: 
 
 
 
 
 
 
 
 
 
 
 
 Expectorated Sputum for Quant Culture of Pa 
X67 
 
 
 
 
 
 
 
 
 
 
Phage Titer/ADA Sampling 
 
 
 
 
 
 
 
 
 
 
 
 
Blood for Phage Titer 
 
 
 
X 
 
X 
 
X 
X 
 
X 
       Induced Sputum for Phage Titer 
 
 
 
 
 
 
 
 
 
 
X68 
 
Expectorated Sputum for Phage Titer69 
 
 
X70 
X71 
X72 
 
 
 
 
 
 
65 Vital signs and oximetry to be measured pre-dose at the designated time points post-first dose of the day 
66 Samples for clinical lab testing obtained pre-first dose on Day 1 if abnormal and clinically significant at Baseline (BL) and results reviewed by Investigator 
prior to administration of study drug; To be analyzed at the site local laboratory. 
67 For subjects who are able to expectorate, sample to be obtained pre-dose on Day 1. Sample may be collected by the subject at home prior to the study visit or 
collected in the clinic. 
68 Sputum induction to be performed LAST at the timepoint indicated 
69 For subjects who are able to expectorate, expectorated sputum for phage titer to be obtained as able post-dose on Day 1, performed at central laboratory (above 
are desired nominal timeframes when sputum samples are to be collected. Actual collection times to be recorded in eCRF.) 
70 If able to expectorate; optimal sample collection timeframe up to 1 hour post Dose 1 
71 If able to expectorate; optimal sample collection timeframe between 2 and 4 hours post Dose 1 (single spot sample, not cumulative during this time period) 
72 If able to expectorate; optimal sample collection timeframe within 1 hour prior to Dose 2 (single spot sample, do not combine with 2-4 hour sample) 

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Table H: Timing of Sample Collection and Procedures on Dosing Days 2-4 and 8-10 for MAD Cohort 4 
Test/Procedure 
Pre- First Dose 
Nominal Times Post First Dose 
 
 
Time 0 
10 min 
15 min 
30 min 
45 min 
60 min 
2 hr 
5 hr 
6 hr 
7 hr 
Study Drug Administration 
 
X 
 
 
 
 
 
 
 
X 
 
Spirometry 
X 
 
 
 
X 
 
 
 
 
 
X 
Vital Signs & Oximetry73 
X 
 
 
 
 
 
X 
 
 
X 
X 
Blood for Safety Labs74  
X 
 
 
 
 
 
 
 
 
 
 
Phage Titer 
 
 
 
 
 
 
 
 
 
 
 
 
Blood for Phage Titer 
X 
 
 
X75 
 
X75 
 
X75 
 
X75 
X75 
 
Expectorated Sputum for Phage Titer 
X76 
 
 
 
 
 
 
X77 
X78 
 
 
 
Induced Sputum for Phage Titer 
X79 
 
 
 
 
 
 
 
 
 
X80 
 
Table I: Timing of Sample Collection and Procedures on Dosing Days 5-7 for MAD Cohort 4 
Test/Procedure 
Pre- First Dose 
Nominal Times Post First Dose 
 
 
Time 0 
10 min 
15 min 
30 min 
45 min 
60 min 
2 hr 
5 hr 
6 hr 
7 hr 
Study Drug Administration 
 
X 
 
 
 
 
 
 
 
X 
 
Vital Signs & Oximetry81 
X 
 
 
 
 
 
X 
 
 
X 
X 
 
 
73 Vital signs and oximetry to be measured prior to each dose on Days 2-4 and 8-10, and at the designated time points post-first dose of the day.  
74 Samples for clinical lab testing obtained pre-first dose on Days 2 and 10 only; Safety labs results from the prior visit to be reviewed as available by 
Investigator prior to administration of study drug; To be analyzed at the site local laboratory. 
75 Blood for phage titer to be obtained on Day 10 only. 
76 Expectorated sputum for phage titer to be obtained as able pre-first dose on Days 2-4 and 8-10. Sample to be collected by the subject at home the morning just 
prior to the study visit (if the subject is able to expectorate). 
77 If able to expectorate; optimal sample collection timeframe up to 2 hours post-first dose of the day (single spot sample do not combine with 2–4-hour sample). 
78 If able to expectorate; optimal sample collection timeframe between 2 and 4 hours post-first dose of the day (single spot sample, not cumulative during this 
time period). 
79 Induced sputum for phage titer to be obtained pre-first dose on Days 2, 3, 4, 8, and 9. 
80 Induced sputum for phage titer to be obtained last on Day 10 only. 
81 Vital signs and oximetry to be measured pre each dose, and 60 minutes post each dose on Days 5-7.  
I 
I 
I 
I 

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APPENDIX 2 
ADULT CFQ-R (ENGLISH)  
 
Adolescents and Adults (Patients 14 Years Old and Older) 
CYSTIC FIBROSIS QUESTIONNAIRE· REVISED 
Understanding the impact of your illness and treatments on your everyday life can help your healthcare team 
keep track of your health and adjust your treatments. For this reason, this questionnaire was specifically 
developed for people who have cystic fibrosis. Thank you for your willingness to complete this form. 
Instructions: The following questions are about the current state of your health, as you perceive it. This 
information will allow us to better understand how you feel in your everyday life. 
Please answer all the questions. There are no right or wrong answers! If you are not sure how to 
answer, choose the response that seems closest to your situation. 
Section I. Demographics I 
--------------- Please fill-in the information or check the box indicating your answer. 
A. What is your date of birth? 
Datell!I! 
Mo 
Day 
Year 
B. What is your ~nder? 
D l\llale 
U Female 
C. During the past two weeks, have you been on vacation or 
out of school or work for reasons NOT related to your 
health? 
D Yes 
□No 
D. What is your current marital status? 
D Single/never married 
D Married 
D Widowed 
D Divorced 
D Separated 
D Remarried 
D With a partner 
E. Which of the following best describes your racial 
background? 
D Caucasian 
D African American 
D Hispanic 
D Asian/Oriental or Pacific Islander 
D Native American or Native Alaskan 
D Other (please describe) _________ _ 
D Prefer not to answer this question 
CYltlc 
Fibrosis 
F. What is the highest grade of school you have completed? 
D Some high school or less 
□ High school diploma/GED 
D Vocational school 
D Some college 
D College degree 
D Professional or graduate degree 
G. Which of the following best describes your current work 
or school status? 
D Attending school outside the home 
D Taking educational courses at home 
D Seeking work 
D Working full or part time (either outside the home or 
at a home-based business) 
D Full time homemaker 
D Not attending school or working due to my health 
D Not working for other reasons 
Foundation ©2000, Quittner, Modi, Watrous and Messer. Revised 2002. CFQ-R Teen/Adult, English Version 2.0 
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Version Date: 13 August 2021 
 
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Adolescents and Adults (Patients 14 Years O ld and Older) 
CYSTIC FIBROSIS QUESTIONNAIRE · REVISED 
Section II. Quality of Life I 
.______________ Please check the box i11dicati11g your answer. 
A lot of 
Some 
A little 
During the past two weeks, to what extent have you had difficulty: 
difficulty 
difficulty 
difficulty 
1. Performing vigorous activities such as running or playing sports 
□ 
□ 
□ 
2. Walking as fast as others 
□ 
□ 
□ 
3. Carrying or lifting heavy things such as books, groceries, or school bags .... 
□ 
□ 
□ 
4. Climbing one flight of stairs .. 
□ 
□ 
□ 
5. Clim bing stairs as fast as others 
□ 
□ 
□ 
D 11ri11g the past two weeks, indicate how often: 
Always 
Often 
Somet·lmes 
6. You felt well 
□ 
□ 
□ 
7. You felt worried 
□ 
□ 
□ 
8. You felt use less 
□ 
□ 
□ 
9. You felt tired ........... .... . 
□ 
□ 
□ 
10. You felt energetic .. 
□ 
□ 
□ 
11. You felt exhausted 
□ 
□ 
□ 
12. You felt sad 
□ 
□ 
□ 
Please circle the 1111mber i11dicati11g yo11r a11swer. Please choose 011/y 011e a11swer for each q11estion. 
Thinking about the state of your health over the last two weeks: 
13. To what extent do you have difficulty walking? 
I. You can walk a long time without getting tired 
2. 
You can walk a long time but you get tired 
3. 
You cannot walk a long tin1e because you get tired quickly 
4. 
You avoid walking whenever possible because it's too tiring for you 
14. How do you feel about eating? 
I . 
Just thinking about food makes you feel sick 
2. 
You never enjoy eating 
3. 
You are sometimes able to enjoy eating 
4. 
You are always able to enjoy eating 
15. To what extent do your treatments make your daily life more difficult? 
I. Not at all 
2. 
A little 
3. 
Moderately 
4. 
A lot 
r.T.J'~~ • 
.. 
Foundadon ©2000, Quittner, Mcxli, Watrous and Messer. Revised 2002. CFQ-R Teen/Adult, English Version 2.0 
No 
difficulty 
□ 
□ 
□ 
□ 
□ 
Never 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
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Adolescents and Adults (Patients 14 Years O ld and Older) 
CYSTIC FIBROSIS QUESTIONNAIRE· REVISED 
16. How much time do you currently spend each day on your treatments? 
I. A lot 
2. 
Some 
3. 
A little 
4. 
Not very much 
17. How difficult is it for you to do your treatments (including medications) each day? 
I. Notatall 
2. 
A little 
3. 
Moderately 
4. 
Very 
18. How do you think your health is now? 
I. Excellent 
2. 
Good 
3. 
Fair 
4. 
Poor 
Please select a box indicating your answer. 
Thinking about your health during the past two weeks, indicate the 
extent to which each sentence is true or false for you. 
19. I have trouble recovering after physical effort. .. 
20. I have to limit vigorous activities such as running or playing sports .. 
21. I have to force myself to eat 
22. I have to stay at home more than I want to 
23. I feel comfortable discussing my illness with others .. 
24. I think I am too thin 
25. I think I look different from others my age ... 
26. I feel bad about my physical appearance 
27. People are afraid that I may be contagious 
28. I get together with my friends a lot 
29. I think my coughing bothers others 
30. I feel comfortable going out at night 
31. I often feel lonely 
32. I feel healthy .. 
33. It is difficult to make plans for the future (for example, going to college, getting 
married, advancing in a job, etc.) ... 
34. I lead a normal life 
Very 
Somewhat 
Somewhat 
true 
true 
false 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
r.T.J'~~ • 
.. 
Foundadon ©2000, Quittner, Mcxli, Watrous and Messer. Revised 2002. CFQ-R Teen/Adult, English Version 2.0 
Very 
false 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
Page 3 

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Adolescents and Adults (Patients 14 Years Old and Older) 
CYSTIC FIBROSIS QUESTIONNAIRE - REVISED 
Section III. School, Work, or Daily Activities 
Questions 35 througlz 38 are about sclzool, work, or other daily tasks. 
35. To what extent did you have trouble keeping up with your schoolwork, professional work, or other daily activities during the past 
two weeks? 
1. 
You have had no trouble keeping up 
2. 
You have managed to keep up but it's been difficult 
3. 
You have been behind 
4. 
You have not been able to do these activities al all 
36. How often were you absent from school, work, or unable to complete daily activities during the last two weeks because of your 
illness or treatments? 
D Always 
D Often 
D Sometimes 
D Never 
37. How often does CF get in the way of meeting your school, work, or personal goals 
D Always 
D Often 
D Sometimes 
D Never 
38. How often does CF interfere with getting out of the house to run errands such as shopping or going to the bank? 
D Always 
□ Often 
D Sometimes 
D Never 
Section IV. Symptom Difficulties I 
._ __________________ Please select a box indicating your answer. 
Indicate how you have been feeling during the past two weeks. 
A great deal 
Somewhat 
A little 
39. Have you had trouble gaining weight? 
.................. . 
□ 
□ 
□ 
40. Have you been congested? ...................... . 
□ 
□ 
□ 
41. Have you been coughing during the day? ................................................ . 
□ 
□ 
□ 
42. Have you had to cough up mucus? ........................................................... . 
□ 
□ 
□ 
Not at all 
□ 
□ 
□ 
□ 
Goto 
43. Has your mucus been mostly: D Clear D Clear lo yellow 
How often during the past hvo weeks: 
1 Question 44 1 
D Yellowish-green D Green with traces of blood D Don't know 
Always 
Often 
44. Have you been wheezing? ... 
□ 
□ 
45. Have you had trouble breatl1ing? .......... ................................................... . 
□ 
□ 
46. Have you woken up during the night because you were coughing?. 
□ 
□ 
47. Have you had problems with gas? .. ..................................... . 
□ 
□ 
48. Have you had diarrhea? ............ .............................................................. . 
□ 
□ 
49. Have you had abdominal pain? ................. . 
□ 
□ 
50. Have you had eating problems? .......... . 
□ 
□ 
Please be sure you lzave answered all tlze questions. 
THANK YOU FOR YOUR COOPERATION! 
Cvstlc 
R&ro.11 
Sometimes 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
Foundation ©2000, Qu~lner, Modi, Watrous and Messer. Revised 2002. CFQ-R Teen/Adult, English Version 2.0 
Never 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
Page 4 

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Version Number: 6.0 
Protocol Number: AP-PA02-101 
 
Version Date: 13 August 2021 
 
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Adolescents and Adults (Patients 14 Years Old and Older) 
CYSTIC FIBROSIS QUESTIONNAIRE - REVISED 
Section III. School, Work, or Daily Activities 
Questions 35 through 38 are about school, work, or other daily tasks. 
35. To what extent did you have trouble keeping up with your schoolwork, professional work, or other daily activities during the past 
two weeks? 
1. 
You have had no trouble keeping up 
2. 
You have managed to keep up but it's been difficult 
3. 
You have been behind 
4. 
You have not been able to do these activities at all 
36. How often were you absent from school, work, or unable to complete daily activities during tl1e last two weeks because of your 
illness or treatments? 
D Always 
D Often 
D Sometimes 
D Never 
37. How often does CF get in the way of meeting your school, work, or personal goals 
D Always 
D Often 
D Sometimes 
D Never 
38. How often does CF interfere witl1 getting out of the house to run errands such as shopping or going to the bank? 
D Always 
□ Often 
D Sometimes 
D Never 
Section IV. Symptom Difficulties I 
__________________ Please select a box indicating your answer. 
Indicate how you have been feeling during the past two weeks. 
A great deal 
Somewhat 
39. Have you had trouble gaining weight? ........................... . 
□ 
□ 
40. Have you been congested? .................... . 
□ 
□ 
41. Have you been coughing during tlte day? ............................ . 
□ 
□ 
42. Have you had to cough up mucus? ........................................................... . 
□ 
□ 
A little 
□ 
□ 
□ 
□ 
Not at all 
□ 
□ 
□ 
□ 
Go to 
43. Has your mucus been mostly: D Clear D Clear to yellow 
How often during the past two wee/,s: 
1 Question 44 
D Yellowish-green D Green with traces of blood D Don't know 
Always 
Often 
Sometimes 
44. Have you been wheezing? .................... .......................... . 
□ 
□ 
□ 
45. Have you had trouble breathing? ............................................................. . 
□ 
□ 
□ 
46. Have you woken up during the night because you were coughing? 
□ 
□ 
□ 
47. Have you had problems with gas? ................................................... . 
□ 
□ 
□ 
48. Have you had diarrhea? ....... ................................ .......................... . 
□ 
□ 
□ 
49. Have you had abdominal pain? ...... . 
□ 
□ 
□ 
50. Have you had eating problems? ................................................................ . 
□ 
□ 
□ 
Please be sure you have answered all the questions. 
THANK YOU FOR YOUR COOPERA TION! 
~~~-
.. 
Foundation ©2000, Qu~tner, Modi, Watrous and Messer. Revised 2002. CFQ-R Teen/Adult. English Version 2.0 
Never 
□ 
□ 
□ 
□ 
□ 
□ 
□ 
Page4 

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APPENDIX 3 
CFRSD-CRISS  
 
 
 
Cystic Fibrosis Respiratory 
Symptom Diary - (CFRSD@) 
Self-Report - Version 2.0 
Daily Recall 
University Of Washington 
Seattle Quality of Life Group and Department of Medicine 
© University of Washington 
Do not reproduce or circulate without permission of the authors. 
This work has been supported with a grant from the Cystic Fibrosis 
Foundation 

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Version Date: 13 August 2021 
 
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Date 
Participant's Initials 
DD 
MMM 
yyyy 
FIRST MIDDLE LAST 
Cystic Fibrosis: Your Daily Experience 
Instructions: 
Participant ID# 
► Complete this diary between 5:00 P.M. and when you go to bed each evening. 
► Think carefully about your experience with cystic fibrosis, specifically during 
the last 24 hours, before responding to each question. The "last 24 hours" is the 
amount of time that has passed since the same time the previous day. 
► Please complete all of the questions in one sitting if possible. 
What is today's date? (write-in your answer): 
What is the current time? (write-in your answer, 
and circle "AM" (before noon) or "PM" (after 
noon): 
Page 1 
August 14, 2012; Version 2.0 
~ University of Washington 
M ONTH 
o'clock 
----
Do not reproduce or circulate without permission of the authors. 
, --- 20 -
-
DAY 
YEAR 
AM 
PM 

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Date 
DD 
MMM 
yyyy 
During the last 24 hours ... 
I. How difficult was it to breathe? 
(CheckQ!!§) 
During the last 24 hours ... 
2. How feverish did you feel (have 
a temperature)? (Check QJliU 
During the last 24 hours ... 
3. How tired did you feel? 
(Check Q!!§) 
During the last 24 hours ... 
4. How bad were your chills or 
sweats? (Check Q!!§) 
Page2 
August 14, 201 2; Version 2.0 
© University of Washington 
Participant's Initials 
Participant ID# 
FJRST MIDDLE LAST 
Not difficult .............................................. D 
A little difficult ........................................ D 
Somewhat difficult ................................... D 
A good deal difficult ................................ D 
A great deal difficult ................................ D 
Not feverish .............................................. D 
A little feverish ........................................ D 
Somewhat feverish ................................... D 
A good deal feverish ................................ D 
A great deal feverish ................................ D 
Nottired ................................................... D 
A little tired .............................................. □ 
Somewhat tired ........................................ D 
A good deal tired ...................................... D 
A great deal tired ...................................... D 
No chills or sweats ................................... D 
Slightly Bad ............................................. □ 
Moderately Bad ........................................ D 
VeryBad .......... ........................................ D 
fa-tremely Bad ......................................... D 
Please continue to the next page. 
Do not reproduce or circulate without permission of the authors. 

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Page 113 of 115 
Proprietary and Confidential 
 
 
 
 
 
Date 
DD 
MMM 
yyyy 
During the last 24 hours ... 
5. How bad was your cough? 
(Check QI!§) 
During the last 24 hours ... 
6. How much mucus did you 
cough up? (Check QJW 
Dming the last 24 hours ... 
7. How much tightness in the chest 
did you have? (Check QJW 
During the last 24 hours ... 
8. 
How bad was your wheezing? 
(CheckQJW 
Page 3 
August 14, 2012; Version 2.0 
© University of Washington 
Participant's Initials 
Participant ID# 
FIRST MIDDLE LAST 
No cough .................................................. □ 
Slightly Bad .............. ... ............................ □ 
Moderately Bad ........................................ D 
Very Bad .................................................. □ 
Extremely Bad ......................................... D 
Nomucus ................................................. D 
A little mucus ............ ............................... D 
Some mucus .............. ............ ................... D 
A good deal of mucus ........... ................... D 
A great deal of mucus ........... ................... D 
No tightness .............. ............ ................... D 
A little tightness .................... ................... D 
Some tightness ......................................... D 
A good deal of tightness .......................... D 
A great deal of tightness ....... ................... D 
No wheezing ............................................ D 
Slightly Bad .............. ............................... □ 
Moderately Bad ......... ............................... D 
Very Bad ............................... ................... □ 
Extremely Bad ...................... ................... D 
Please continue to the next page. 
Do not reproduce or circulate without permission of the authors. 

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Date 
DD 
MMM 
yyyy 
During the last 24 hours ... 
9. How difficult was it to sleep? 
(Check Q!2§) 
During the last 24 hours ... 
10. How worried were you about 
your cystic fibrosis? 
(Check Q!2§) 
During the last 24 hours ... 
11. How cranky did you feel? 
(Check Q!2§) 
During the last 24 hours ... 
12. How sad or depressed did you 
feel? (Check Q!2§) 
Page 4 
August 14, 2012; Version 2.0 
«:J University of Washington 
Participant's Initials 
Participant ID# 
FIRST MIDDLE LAST 
Not difficult .............................................. D 
A little difficult ........................................ □ 
Somewhat difficult ................................... D 
A good deal difficult ................................ D 
A great deal difficult ................................ D 
Not worried .............................................. D 
A little worried ......................................... D 
Somewhat worried ................................... D 
A good deal worried ................................. D 
A great deal worried ................................. D 
Not cranky ................................................ D 
A little cranky .......................................... D 
Somewhat cranky ......... ............................ D 
A good deal cranky .................................. D 
A great deal cranky .................................. D 
Not sad or depressed ................................ D 
A little sad or depressed ........................... D 
Somewhat sad or depressed ..................... D 
A good deal sad or depressed ................... D 
A great deal sad or depressed ................... D 
Please continue to the next page. 
Do not reproduce or circulate without permission of the authors. 

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Date 
DD 
MMM 
yyyy 
During the last 24 hours ... 
13. How frustrated did you feel? 
(Check Q!2§) 
During the last 24 hours ... 
14. How much time did you spend 
sitting or lying down? 
(Check Q!2§) 
Dming the last 24 hours ... 
15. Did you reduce your usual 
activities? (Check Q!2§) 
During the last 24 hours ... 
16. Did you miss work or school? 
(Check Q!2§) 
Page 5 
August 14, 2012; Version 2.0 
«:J University of Washington 
Participant's Initials 
Participant ID# 
FIRST MIDDLE LAST 
Not frustrated ........................................... D 
A little frustrated ...................................... D 
Somewhat frustrated ................................ D 
A good deal frustrated .............................. D 
A great deal frustrated .............................. D 
Hardly any of the time ............................. D 
Some of the time ...................................... D 
Most of the time ....................................... D 
All of the time .......................................... D 
Yes ........................................................... D 
No ............................................................. □ 
Yes ........................................................... D 
No ............................................................. □ 
Does not apply, I did not have 
work or school in the last 24 hours .......... D 
Do not reproduce or circulate without permission of the authors.