A Phase 1, Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Intravenous and Oral Doses of Omadacycline in Pediatric Subjects With Suspected or Confirmed Bacterial Infections
Phase: PHASE1
Conditions: Bacterial Infections
Sponsor: Paratek Pharmaceuticals Inc

Clinical Trial Protocol:  PTK0796-PEDPK-20110
Study Title: 
A Phase 1, Open-Label, Multi-Center Study to Evaluate the Safety, 
Tolerability and Pharmacokinetics of Single Intravenous and Oral 
Doses of Omadacycline in Pediatric Subjects with Suspected or 
Confirmed Bacterial Infections 
Study Number: 
PTK0796-PEDPK-20110 
Study Phase: 
1 
Product Name: 
Omadacycline (PTK 0796) 
IND Number: 
75,928 
73,431 
Indication: 
Bacterial Infection 
Investigators: 
Multi-center 
Sponsor: 
Paratek Pharmaceuticals, Inc. 
75 Arlington Street 
Suite 500  
Boston, MA 02116 
1000 First Ave 
Suite 200 
King of Prussia, PA 19406 
Sponsor 
Contact: 
Tel: +1 617-275-0040 
Global Medical 
Monitor: 
 MD 
Protocol Version 5.0: 
14-Sep-2023
Confidentiality Statement 
The concepts and information contained in this document or generated during the study are 
considered proprietary and may not be disclosed in whole or in part without the expressed, 
written consent of Paratek Pharma, LLC. 
The study was in accordance with the International Council on Harmonisation Harmonized 
Tripartite Guidelines for Good Clinical Practice. 

Omadacycline  
Paratek Pharmaceuticals, Inc. 
PTK0796-PEDPK-20110 Version 5.0 FINAL; -14-Sep-2023 
IND No. 75,928 IND No. 73,431 
 
Confidential and Proprietary 
 
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SYNOPSIS  
Sponsor: 
Paratek Pharmaceuticals, Inc.  
Name of Finished Product: 
Intravenous Omadacycline 100 mg (in 100 mL normal saline solutions) infused over 
30 minutes  
Oral Omadacycline tablet, 300 mg (150 mg tablet x 2) 
Name of Active Ingredient: 
Omadacycline  
Study Title:  
A Phase 1, Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability and 
Pharmacokinetics of Single Intravenous and Oral Doses of Omadacycline in Pediatric 
Subjects with Suspected or Confirmed Bacterial Infections 
Study Number: 
PTK0796-PEDPK-20110 
Study Phase:  1 
Study Rationale: 
As omadacycline is active against the causative organisms in disease indications such as 
acute bacterial skin and skin structure infections (ABSSSI) and community-acquired 
bacterial pneumonia (CABP), it is reasonable to assume that pediatric exposures 
comparable to adults will result in similar efficacy outcomes.  As a class, tetracycline 
antibiotics do not substantially differ in pharmacokinetics (PK) between adults and 
children/adolescents. 
This study is being conducted in children and adolescents already hospitalized and already 
receiving antibacterial treatment.  As such, exposure to a single dose of omadacycline is a 
reasonable added therapy.  Study related blood draws can be performed through indwelling 
catheters already in place.  The study assessments following a single dose of omadacycline 
will be sufficient to characterize the PK of omadacycline and model exposure with 
multiple doses. 
Primary Objective:  
To characterize the PK of single intravenous (iv) and oral doses of omadacycline in 
children and adolescents 8 to < 18 years of age with suspected or confirmed bacterial 
infections. 
 
 

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Secondary Objective: 
To evaluate the safety and tolerability of single iv and oral doses of omadacycline in 
children and adolescents 8 to < 18 years of age with suspected or confirmed bacterial 
infections. 
Study Design: 
This is a Phase 1, open-label, multi-center study in children and adolescent subjects (males 
and females, 8 to < 18 years of age) with suspected or confirmed bacterial infections who 
are receiving concomitant systemic antibacterial therapy.  This study will consist of 2 age 
cohorts: 
• Cohort 1 (adolescents):  12 to < 18 years of age 
• Cohort 2 (children):  8 to < 12 years of age 
The study will consist of a Screening period of up to 48 hours prior to dosing, a single dose 
of study drug on Day 1, and a Study Completion Visit between Days 4-7.   
Subjects will undergo screening evaluations to determine eligibility within 48 hours prior 
to dosing.  Approximately 40 subjects (20 per age cohort) will be enrolled to obtain at least 
24 PK evaluable subjects (with a minimum of 6 subjects per treatment, per age cohort). 
On Day 1, based on Principal Investigator (PI) discretion, subjects will receive either a 
single dose of 100 mg iv omadacycline (in 100 mL normal saline solution) infused over 
30 minutes at room temperature, or they will receive a single dose of 300 mg oral 
omadacycline tablet (150 mg tablet x 2).  Oral study drug will be administered in the 
morning with no food or drink except for water at least 6 hours prior to dosing.  Subjects 
will have no food or drink except water for at least 2 hours after dosing and no dairy 
products, antacids, or other aluminum- or calcium-containing products (e.g., vitamins, 
supplements) for 4 hours after dosing. 
A total of 7 blood samples for PK analysis for oral omadacycline and 8 blood samples for 
iv omadacycline will be collected at specified time points from prior to the time of dosing 
to 48 hours following dosing.  Safety assessments will include monitoring of adverse 
events (AEs), clinical laboratory test results, vital sign measurements, and physical 
examination findings.   
Rationale for Omadacycline Dose Regimen Selection: 
The dosing regimen of omadacycline selected for this study is based on the nonclinical and 
clinical experience to date, including in vitro antibacterial activity, PK characteristics and 
modeling, clinical efficacy in prior studies, the overall safety and tolerability profile, and 
the Food and Drug Administration (FDA) approved dosing regimen for CABP and 
ABSSSI.  Based on interim PK and safety analyses, the dose could be modified during the 
study. 
This study will involve a single dose of either 100 mg iv or 300 mg oral omadacycline in a 
pediatric population in order to establish pediatric dosing as compared to adult subjects.  

Omadacycline  
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PTK0796-PEDPK-20110 Version 5.0 FINAL; -14-Sep-2023 
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Confidential and Proprietary 
 
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Approximate Number of Subjects/Sites:  
Up to 40 subjects (20 per age cohort) will be enrolled at approximately 15 sites in the 
United States (US) to obtain at least 24 PK evaluable subjects (with a minimum of 6 per 
treatment, per age cohort).  
Approximate Duration of the Study: 
The clinical phase of the study is expected to be complete in approximately 12 months.  
The total duration of subject participation in the study, including screening, is 
approximately 9 days.    
Main Criteria for Inclusion: 
Subjects must meet all of the following criteria at Screening and/or Pre-dose to be eligible 
to participate in the study: 
1. Written and signed parental/legal authorized representative (LAR) informed 
consent must be obtained before any protocol specific assessment is performed. 
Pediatric assent should be obtained in accordance with local hospital and IRB 
policies.   
2. Male and female subjects between 8 and < 18 years of age, inclusive at time of 
consent/assent. 
3. Hospitalized, in stable condition, likely to survive the current illness, and receiving 
or planned to receive standard of care systemic antibacterial therapy, other than 
omadacycline, for a suspected or confirmed bacterial infection.   
4. Expected to remain hospitalized for at least 2 days following administration of the 
study drug.  
5. Sufficient intravascular access (peripheral or central) for study drug administration 
(iv treatment only) and blood draws.  
6. For subjects who will receive oral study drug only, ability to swallow oral study 
drug 2 tablets). 
7. Weight within the 5th and 95th percentile for age and sex. 
8. Females of reproductive potential (post-menarche or has reached Tanner Stage 3 
breast development) must have a negative urine or serum pregnancy test and agree 
to use a highly effective form of birth control (e.g., abstinence, oral contraceptive, 
intrauterine device, or barrier contraception [e.g., condom]) from Screening 
through the study completion visit.  Males (if sexually active) must agree to use a 
highly effective method of birth control with female partner(s). 
9. Subject and parent/caregiver is willing and able to adhere with the requirements 
and restrictions of the study. 
Main Criteria for Exclusion: 
Subjects meeting any of the following criteria at Screening and/or Pre-dose will be 
excluded from participation in the study: 

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1. Use of other investigational drugs within 5 half-lives or 30 days prior to Pre-dose, 
whichever is longer. 
2. Evidence or history of a clinically significant medical condition or planned medical 
intervention that may, in the opinion of the investigator, pose a significant safety 
risk, impair study participation, or impact the subject’s ability to undergo the 
required study procedures. (Note: Subjects must, in the opinion of the investigator, 
be physically and mentally competent to participate.) 
3. Inability to tolerate oral medication (e.g., nausea, vomiting, diarrhea, or any other 
condition that might impair ingestion or absorption of oral medication – oral 
treatment only). 
4.  Inability to fast for 6 hours prior to dosing and/or 2 hours after dosing (oral 
treatment only). 
5. Pregnant or nursing (breastfeeding) in post-menarche females. 
6. History of hypersensitivity or allergic reaction (e.g., anaphylaxis, urticaria, other 
significant reaction) to any tetracycline (e.g., minocycline, doxycycline, or 
tigecycline). 
7. Any surgical or medical condition that, in the opinion of the investigator, might 
significantly alter the absorption, distribution, metabolism, or excretion of drugs. 
8. Family members of the Investigator or a study center employee. 
Test Article, Dose, and Mode of Administration:  
• 100 mg iv omadacycline (in 100 mL normal saline solution) infused over 
30 minutes OR 
• 300 mg oral omadacycline tablet (150 mg tablet x 2)  
Duration of Treatment:  
Subjects will receive a single dose of either iv or oral omadacycline.  
Pharmacokinetic Assessments 
Blood samples for PK assessments of omadacycline will be collected from all subjects at 
the following time points:   
Oral Treatment  
• At least 15 minutes prior to administration of oral omadacycline 300 mg and at 1 
hour (±5 min), 2 hours (±5 min), 3 hours (±5 min), 8 hours (±1 hr.), 24 hours (±1 
hr.) and 48 hours (±1 hr.) after dosing  
Intravenous Treatment  
• At least 15 minutes prior to infusion of IV omadacycline 100 mg, at 10 minutes (±5 
minutes), 0.5-hour (±5 minutes), 1-hour (±5 minutes), 2 hours (±5 minutes), 8 
hours (±1 hr.), 24 hours and 48 hours (±1 hr.) after the end of the IV infusion  
The following plasma PK parameters will be determined: 

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PTK0796-PEDPK-20110 Version 5.0 FINAL; -14-Sep-2023 
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• 
Area under the plasma concentration versus time curve (AUC) from time 0 to 
48hours after dosing (AUC0-48) 
• 
AUC from time 0 to the last quantifiable concentration (AUClast) 
• 
AUC from time 0 extrapolated to infinity (AUC0-inf) 
• 
Maximum observed plasma concentration (Cmax) 
• 
Time to reach maximum observed plasma concentration (Tmax) 
• 
Elimination half-life associated with the terminal slope of the semilogarithmic 
concentration-time curve (T1/2) 
• 
Apparent volume of distribution (Vd) after iv administration only 
• 
Systemic clearance (CL) after iv administration only 
Additional exploratory PK calculations may be performed and will be described in the 
statistical analysis plan. 
Safety Assessments: 
Safety and tolerability will be assessed by monitoring the following: 
• AEs and serious adverse events (SAEs); 
• Physical examinations; 
• Vital signs (body weight, body temperature, blood pressure, heart rate); 
• Clinical laboratory tests (hematology, serum chemistry) 
Statistical Methods: 
Sample Size Determination:  
The sample size selected is based on an estimation approach rather than a formal 
hypothesis testing approach.  An estimation approach with 20 subjects in each age cohort 
(10 subjects per treatment, per age cohort) will be enrolled.  A total of 40 subjects will be 
enrolled so that at least 24 subjects are evaluable for PK parameter estimation (with a 
minimum of 6 subjects per treatment, per age cohort). 
Analysis Populations:  
Safety Population:  The safety population will consist of all assigned subjects who 
received any study drug. 
PK Evaluable Population:  The PK population will include subjects who receive study 
drug and have at least 1 evaluable PK parameter.  If any subject has an emesis within 2.5x 
median Tmax after dosing, the subject may be excluded from PK population. 
Pharmacokinetics Analysis:   
Concentration and time deviation data will be presented in data listings.  Plasma 
concentration data will be summarized by scheduled time point for each treatment using 
descriptive statistics (number of subjects, mean, standard deviation [SD], coefficient of 
variation [CV], median, minimum, and maximum).  Mean and individual plasma 

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PTK0796-PEDPK-20110 Version 5.0 FINAL; -14-Sep-2023 
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concentration versus time profiles will be presented in figures on both linear and 
semilogarithmic scales. 
Noncompartmental PK parameters will be determined from plasma concentration and 
actual time data using Phoenix® WinNonlin® (Certara, Princeton, New Jersey) Version 8.0 
or higher or a WinNonlin validated Statistical Analysis System (SAS) program.  
For the PK analysis, below the limit of quantification (BLQ) values before the first 
quantifiable concentration will be treated as zero.  Below the limit of quantification values 
after the first quantifiable concentration will be set as missing.  Missing concentrations 
will be treated as missing.  If consecutive BLQ concentrations are followed by quantifiable 
concentrations in the terminal phase, those concentrations after BLQ concentrations will be 
treated as missing. 
For concentration summary statistics, BLQ values before the first quantifiable 
concentration will be treated as zero.  Below the limit of quantification values after the first 
quantifiable concentration will be set as missing.  Missing concentrations will be treated as 
missing. 
The individual PK parameters of omadacycline will be presented in data listings.  
Descriptive statistics (number of subjects, mean, SD, CV, median, minimum, and 
maximum) will be calculated for the PK parameter estimates for each period (e.g., AUC0-
48, AUClast, AUC0-inf, Cmax, Tmax, CL (iv arm only), Vd (iv arm only) and T1/2, from plasma 
concentrations).  Geometric means will be included for AUC0-48, AUC0-inf, and Cmax. 
Safety Assessments:   
The safety data will be summarized by treatment where applicable.  The incidence of 
treatment-emergent AEs will be presented by treatment, system organ class, and preferred 
term according to the Medical Dictionary for Regulatory Activities (MedDRA), 
relationship to the study drug, and severity.  Any SAEs and AEs leading to discontinuation 
of study drug will also be presented in a data listing. 
Clinical laboratory test results, vital sign measurements, and physical examination findings 
will be presented in data listings.  Actual results and changes from Baseline for vital sign 
measurements and clinical laboratory test results will be summarized by treatment and 
time point. 
Prior and concomitant medications and therapies will be coded using the latest version of 
the World Health Organization Drug Dictionary and will be presented in a data listing. 
Handling of Missing Data: 
Concentrations that are BLQ before the first quantifiable concentration will be treated as 
zero for descriptive statistics.  Below the limit of quantification values after the first 
quantifiable concentration will be set as missing and excluded for summary statistics.  
Mean BLQ concentrations will be presented as BLQ, and the SD and CV will be reported 
as not applicable, if all individual values are BLQ. 

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PTK0796-PEDPK-20110 Version 5.0 FINAL; -14-Sep-2023 
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Interim Analysis: 
Interim PK and safety analyses will be conducted as data become available to allow for 
dosing modifications and/or sample size adaptation.  
Review of Safety Data: 
Due to the open-label design, safety review and analysis of PK samples will be performed 
on an ongoing basis by the sponsor.  The sponsor study team, including physician and 
pharmacokineticist, will be part of the review.  Safety review will occur at the completion 
of each subject individually and collectively (all subjects) to identify trends, quality 
concerns and any safety issues.  Reviews will include PK analyses, treatment-emergent 
adverse events, SAEs, clinical laboratory results, vital sign measurements and Physical 
Examination findings.  PK data will also be reviewed at periodic intervals and compared to 
the established PK profile in adults.   
 
Based on the reviews, the study may continue as planned, the protocol may be amended to 
include additional safety evaluations or to adjust the dosing, or the study may be paused or 
stopped. 
 
 

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PTK0796-PEDPK-20110 Version 5.0 FINAL; -14-Sep-2023 
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TABLE OF CONTENTS 
SYNOPSIS .................................................................................................................................2 
TABLE OF CONTENTS ...........................................................................................................9 
LIST OF APPENDICES ..........................................................................................................11 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS ..........................................12 
1 
DISCLOSURE STATEMENT ........................................................................................14 
2 
CONTACTS ....................................................................................................................15 
 
Emergency Contacts ..............................................................................................15 
 
Additional Contacts ...............................................................................................15 
3 
INTRODUCTION ...........................................................................................................16 
4 
STUDY OBJECTIVES ....................................................................................................16 
 
Primary Objective ..................................................................................................16 
 
Secondary Objective ..............................................................................................16 
5 
INVESTIGATIONAL PLAN ..........................................................................................17 
 
Overall Study Description......................................................................................17 
 
Rationale for Study Design ....................................................................................18 
 
Approximate Duration of Subject Participation ....................................................18 
 
Approximate Duration of Study .............................................................................18 
 
Approximate Number of Subjects .........................................................................18 
6 
STUDY POPULATION SELECTION ...........................................................................19 
 
Study Population ....................................................................................................19 
 
Inclusion and Exclusion Criteria ............................................................................19 
 
Screen Failures .......................................................................................................20 
7 
STUDY TREATMENT(S) ..............................................................................................21 
 
Treatments Administered .......................................................................................21 
 
Identity of the Investigational Product:  Omadacycline ........................................21 
 
Dose Selection Rationale .......................................................................................22 
 
Description of Treatments......................................................................................22 
 
Test Article Administration ...................................................................................22 
7.5.1 
Administration of Oral and IV Treatment ...................................................22 
 
Dose Adjustments and Interruptions of Test Article .............................................23 
7.6.1 
Subject Numbering ......................................................................................23 
 
Dispensing Test Article..........................................................................................23 
 
Prior and Concomitant Therapy .............................................................................23 
 
Prohibited Therapy.................................................................................................23 
 
Permitted Treatments .............................................................................................23 
 
Treatment Compliance ...........................................................................................24 
 
Packaging and Labeling .........................................................................................24 

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Storage and Accountability ....................................................................................24 
 
Investigational Product Retention at Study Site ....................................................24 
8 
STUDY PROCEDURES .................................................................................................25 
 
Informed Consent and Pediatric Assent .................................................................25 
 
Subject Demographics/Other Baseline Characteristics .........................................25 
 
Medical History .....................................................................................................25 
 
Physical Examination.............................................................................................25 
 
Vital Signs ..............................................................................................................26 
 
Height, Weight, and BMI.......................................................................................26 
 
Clinical Laboratory Tests .......................................................................................26 
8.7.1 
Hematology and Serum Chemistry ..............................................................26 
8.7.2 
Pregnancy Assessment .................................................................................27 
 
Pharmacokinetic Assessments ...............................................................................27 
8.8.1 
PK Blood Collection and Processing ...........................................................28 
 
Adverse Events ......................................................................................................28 
 
Serious Adverse Events .........................................................................................28 
 
Other Reportable Information ................................................................................29 
 
Overdose ................................................................................................................30 
 
Medication Errors ..................................................................................................30 
 
Recording and Reporting .......................................................................................30 
8.14.1 
Serious Adverse Event Reporting ................................................................31 
8.14.2 
Assessment of Relatedness ..........................................................................31 
8.14.3 
Assessment of Severity ................................................................................31 
8.14.4 
Laboratory Findings .....................................................................................32 
8.14.5 
Pregnancies ..................................................................................................32 
 
Concomitant Medication Assessments ..................................................................32 
 
Subject Discontinuation or Withdrawal .................................................................33 
8.16.1 
Replacements ...............................................................................................33 
9 
STUDY ACTIVITIES .....................................................................................................34 
 
Screening Phase .....................................................................................................34 
 
Treatment Phase .....................................................................................................34 
 
Study Completion Visit Procedures .......................................................................34 
10 STUDY SUSPENSION, TERMINATION, AND COMPLETION ................................35 
 
Study Completion and Post-Study Test Article .....................................................35 
 
Study Suspension or Termination ..........................................................................35 
11 QUALITY CONTROL AND ASSURANCE .................................................................36 
12 PLANNED STATISTICAL METHODS ........................................................................37 
 
General Considerations ..........................................................................................37 

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Determination of Sample Size ...............................................................................37 
 
Analysis Populations ..............................................................................................37 
 
Interim Analysis .....................................................................................................37 
 
Review of Safety Data ...........................................................................................37 
 
Demographics and Baseline Characteristics ..........................................................38 
 
Primary Endpoints .................................................................................................38 
12.7.1 
Pharmacokinetic Endpoint ...........................................................................38 
 
Secondary Endpoints .............................................................................................39 
12.8.1 
Safety Endpoints ..........................................................................................39 
 
Data Handling Conventions ...................................................................................40 
 Multiple Comparisons and Multiplicity .................................................................40 
 General Data Summaries .......................................................................................40 
13 ADMINISTRATIVE CONSIDERATIONS ....................................................................41 
 
Investigators and Study Administrative Structure .................................................41 
 
Institutional Review Board or Independent Ethics Committee Approval .............41 
 
Ethical Conduct of the Study .................................................................................41 
 
Patient Information and Consent ...........................................................................41 
 
Direct Access, Data Handling, and Record Keeping .............................................41 
13.5.1 
Investigator ..................................................................................................41 
13.5.2 
Sponsor ........................................................................................................42 
 
Protocol Adherence ................................................................................................42 
13.6.1 
Violations/Deviations ..................................................................................42 
13.6.2 
Protocol Amendments ..................................................................................42 
 
Subject Injury .........................................................................................................42 
 
Pre-Study Documentation ......................................................................................43 
 
Retention of Data ...................................................................................................43 
 Publication and Disclosure Policy .........................................................................44 
14 REFERENCE LIST .........................................................................................................45 
Appendix 1. 
Schedule of Assessments ...................................................................46 
Appendix 2. 
Sponsor Signature ..............................................................................51 
Appendix 3. 
Investigator’s Signature .....................................................................52 
 
LIST OF APPENDICES  
Appendix 1. 
Schedule of Assessments .............................................................................46 
Appendix 2. 
Sponsor Signature ........................................................................................51 
Appendix 3. 
Investigator’s Signature ...............................................................................52 
 

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LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS  
ABSSSI 
acute bacterial skin and skin structure infections 
AE 
Adverse Event 
ALT 
alanine aminotransferase  
AST 
aspartate aminotransferase  
AUC 
area under the plasma concentration versus time curve 
AUC0-48 
AUC from time 0 to 48 hours after dosing 
AUC0-inf 
AUC from time 0 extrapolated to infinity 
AUClast 
AUC from time 0 to the last quantifiable concentration 
BLQ 
below the limit of quantification 
BP 
blood pressure 
CABP 
community-acquired bacterial pneumonia 
CFR 
Code of Federal Regulations 
CL 
clearance (Pharmacokinetics) 
Cmax 
maximum observed plasma concentration 
CRF 
case report form 
CSA 
clinical study agreement 
CSR 
Clinical Study Report 
CV 
coefficient of variation 
DMC 
Data Monitoring Committee 
EC 
Ethics Committee 
eCRF 
electronic case report form 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
ICF 
Informed Consent Form 
ICH 
International Council on Harmonization 
IEC 
Independent Ethics Committee 
IND 
Investigational New Drug 

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IRB 
Institutional Review Board 
iv 
Intravenous 
LAR 
legal authorized representative 
MedDRA 
Medical Dictionary for Regulatory Activities 
PI 
Principal Investigator 
PK 
Pharmacokinetics 
po 
per oral 
REB 
Research Ethics Board 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SARS-CoV-2 
severe acute respiratory syndrome coronavirus 2 
SAS 
SD 
statistical analysis system 
standard deviation 
Tmax 
time to reach maximum observed plasma concentration 
T1/2 
terminal-phase elimination half-life 
US 
United States 
Vd 
volume of distribution 
WBC 
white blood cell (Count) 

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1 
DISCLOSURE STATEMENT  
Restricted Distribution of Documents 
This document contains information that is confidential and proprietary to the sponsor.  This 
information is being provided to you solely for the purpose of evaluating and/or conducting a 
clinical study for the sponsor.  You may disclose the contents of this document only to study 
personnel under your supervision, Institutional Review Boards (IRBs)/Independent Ethics 
Committees (IECs)/Research Ethics Boards (REBs), or duly authorized representatives of 
regulatory agencies for this purpose under the condition that they maintain confidentiality.  
The contents of this document may not be used in any other clinical study, disclosed to any 
other person or entity, and/or published without the prior written permission of the sponsor.  
The foregoing shall not apply to disclosure required by any regulations; however, you will 
give prompt notice to the sponsor of any such disclosure.  All other nonpublic information 
provided by the sponsor and any information that may be added to this document also is 
confidential and proprietary to the sponsor and must be kept in confidence in the same 
manner as the contents of this document. 

Omadacycline  
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2 
CONTACTS  
 
Emergency Contacts  
Name/Title: 
 
 
 
 
 
 
, MD 
Global Medical Monitor 
Phone (during business hours): 
 
Phone (after business hours):  
 
E-mail (not for emergencies):  
 
 
 
 
Additional Contacts  
SAE contact information: 
E-Mail: 
 
 
 
 
 
 
 
 
 

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3 
INTRODUCTION  
Omadacycline is an aminomethylcycline, a tetracycline class antibiotic, for intravenous (iv) 
or oral (po) administration.  Intravenous NUZYRA® (omadacycline) and oral NUZYRA® 
tablets have been approved by the United States (US) Food and Drug Administration (FDA) 
for the treatment of adult patients with community-acquired bacterial pneumonia (CABP) 
and acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible 
microorganisms. 
As omadacycline is active against the causative organisms in potential disease indications 
such as ABSSSI and CABP, it is reasonable to assume that pediatric exposures comparable 
to adults will result in similar efficacy outcomes.  Therefore, it is necessary to determine the 
doses required to achieve these exposures.  As a class, tetracycline antibiotics do not 
substantially differ in pharmacokinetics (PK) between adults and children/adolescents. 
This study is intended to evaluate the safety, tolerability, and characterize the PK of an 
intravenous and oral formulation of omadacycline in order to establish pediatric dosing as 
compared to adult subjects.   
Please refer to the current version of the Investigator's Brochure1 or the NUZYRA® 
(omadacycline) US Package Insert for additional information on omadacycline. 
4 
STUDY OBJECTIVES  
 
Primary Objective  
The primary objective of this study is:  
• To characterize the PK of single intravenous and oral doses of omadacycline in children 
and adolescents 8 to < 18 years of age with suspected or confirmed bacterial infections. 
 
Secondary Objective  
The secondary objective of this study is: 
• To evaluate the safety and tolerability of single intravenous and oral doses of 
omadacycline in children and adolescents 8 to < 18 years of age with suspected or 
confirmed bacterial infections. 

Omadacycline  
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5 
INVESTIGATIONAL PLAN  
 
Overall Study Description  
This is a Phase 1, open-label, multi-center study in children and adolescent subjects (males 
and females, 8 to < 18 years of age) with suspected or confirmed bacterial infections who are 
receiving concomitant systemic antibacterial therapy.  This study will consist of 2 age 
cohorts: 
• Cohort 1 (adolescents):  12 to < 18 years of age 
• Cohort 2 (children):  8 to < 12 years of age 
The study will consist of a Screening period of up to 48 hours prior to dosing, a single dose 
of study drug on Day 1 and a Study Completion Visit between Days 4 to 7. 
Subjects will undergo screening evaluations to determine eligibility within 48 hours prior to 
dosing.  Approximately 40 subjects (20 per age cohort) will be enrolled. 
On Day 1, per Principal Investigator (PI) discretion, subjects will receive a single dose of 
either intravenous or oral omadacycline.  For those receiving intravenous omadacycline, a 
100 mg IV dose (in 100 mL normal saline solution) infused over 30 minutes at room 
temperature will be administered.  For those receiving oral omadacycline, a single dose of 
300 mg oral omadacycline tablet (150 mg tablet x 2) will be administered. 
Oral study drug will be administered in the morning in a fasted state with no food or drink 
except for water at least 6 hours prior to dosing.  Fasting is defined as no food, antacids, or 
multivitamins containing multivalent cations (e.g., aluminum, magnesium, calcium, bismuth, 
iron, or zinc) or drink except water for at least 6 hours before dosing.  Subjects will have no 
food or drink except water for at least 2 hours after dosing and no dairy products, antacids, or 
other aluminum- or calcium-containing products (e.g., vitamins, supplements) for 4 hours 
after dosing. 
A total of 7 blood samples for PK analysis for oral omadacycline and 8 blood samples for iv 
omadacycline will be collected at specified time points prior to dosing and through 48 hours 
after dosing.  Safety assessments will include monitoring of adverse events (AEs), clinical 
laboratory test results, vital sign measurements, and physical examination findings. 
Subjects will complete a Study Completion visit 4 to 7 days after dose completion.  This visit 
may be performed via telehealth with subject’s parent/legal authorized representative (LAR) 
to review ongoing medications and adverse events if the subject has already been discharged 
from the hospital before Day 4.  
Refer to the Schedule of Events (Appendix 1) for the summary of subject visits and 
assessments through study completion.  
The planned length of subject participation in the study is up to 9 days.   

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Rationale for Study Design  
As omadacycline is active against the causative organisms in disease indications such as 
ABSSSI and CABP, it is reasonable to assume that pediatric exposures comparable to adults 
will result in similar efficacy outcomes.  As a class, tetracycline antibiotics do not 
substantially differ in PK between adults and children/adolescents. 
This study is being conducted in children already hospitalized and already receiving 
antibacterial treatment.  As such, exposure to a single dose of omadacycline is a reasonable 
added therapy.  Study related blood draws can be performed through indwelling catheters 
already in place.  The study assessments following a single dose of omadacycline will be 
sufficient to characterize the PK of omadacycline and model exposure with multiple doses. 
 
Approximate Duration of Subject Participation  
Subjects will participate in the study for up to 9 days.   
 
Approximate Duration of Study  
The study is expected to be complete in approximately 12 months.  
 
Approximate Number of Subjects  
Up to 40 subjects will be enrolled at approximately 15 sites in the US to obtain at least 24 PK 
evaluable subjects with a minimum of 6 subjects per treatment, per age cohort.   

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6 
STUDY POPULATION SELECTION  
Each subject and his/her parent/LAR must participate in the informed consent process and 
sign and date an IRB/IEC/REB approved pediatric assent and informed consent form (ICF) 
before any procedures specified in this protocol are performed. 
 
Study Population  
Hospitalized children and adolescents between the ages of 8 and < 18 with suspected or 
confirmed bacterial infections who are receiving concomitant systemic antibacterial therapy 
will participate in this study.  Up to 40 subjects will be enrolled at approximately 15 sites in 
the US to obtain at least 24 PK evaluable subjects with a minimum of 6 subjects per 
treatment, per age cohort.   
 
Inclusion and Exclusion Criteria  
Each subject must meet all of the following criteria at Screening and/or Pre-dose to be 
eligible to participate in the study: 
Main Criteria for Inclusion: 
1. Written and signed parental/LAR informed consent must be obtained before any 
protocol specific assessment is performed. Pediatric assent should be obtained in 
accordance with local hospital and IRB policies.    
2. Male and female subjects between 8 and < 18 years of age, inclusive at time of 
consent/assent. 
3. Hospitalized, in stable condition, likely to survive the current illness, and receiving or 
planned to receive standard of care systemic antibacterial therapy, other than 
omadacycline, for a suspected or confirmed bacterial infection.   
4. Expected to remain hospitalized for at least 2 days following administration of the 
study drug.  
5. Sufficient intravascular access (peripheral or central) for study drug administration 
(iv treatment only) and blood draws.  
6. For subjects who will receive oral study drug only, ability to swallow oral study drug 
(2 tablets). 
7. Weight within the 5th and 95th percentile for age and sex. 
8. Females of reproductive potential (post-menarche or has reached Tanner Stage 3 
breast development) must have a negative urine or serum pregnancy test and agree to 
use a highly effective form of birth control (e.g., abstinence, oral contraceptive, 
intrauterine device, or barrier contraception [e.g., condom]) from Screening through 
the study completion visit.  Males (if sexually active) must agree to use a highly 
effective method of birth control with female partner(s). 
9. Subject and parent/caregiver is willing and able to adhere with the requirements and 
restrictions of the study. 

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Main Criteria for Exclusion: 
Subjects meeting any of the following criteria at Screening and/or Pre-dose will be excluded 
from participation in the study: 
1. Use of other investigational drugs within 5 half-lives or 30 days prior to Pre-dose, 
whichever is longer. 
2. Evidence or history of a clinically significant medical condition or planned medical 
intervention that may, in the opinion of the investigator, pose a significant safety risk, 
impair study participation, or impact the subject’s ability to undergo the required 
study procedures. (Note: Subjects must, in the opinion of the investigator, be 
physically and mentally competent to participate.) 
3. Inability to tolerate oral medication (e.g., nausea, vomiting, diarrhea, or any other 
condition that might impair ingestion or absorption of oral medication – oral 
treatment only). 
4. Inability to fast for 6 hours prior to dosing and/or 2 hours after dosing (oral treatment 
only). 
5. Pregnant or nursing (breastfeeding) in post-menarche females. 
6. History of hypersensitivity or allergic reaction (e.g., anaphylaxis, urticaria, other 
significant reaction) to any tetracycline (e.g., minocycline, doxycycline, or 
tigecycline). 
7. Any surgical or medical condition that, in the opinion of the investigator, might 
significantly alter the absorption, distribution, metabolism, or excretion of drugs. 
8. Family members of the Investigator or a study center employee. 
 
Screen Failures  
Subjects who sign the ICF but withdraw or are withdrawn from the study before treatment 
are defined as screen failures.  All screen failures should be recorded on the subject master 
list.  Limited information including reason for screen failure will be recorded on the 
electronic case report form (eCRF) for screen failures.  Screen failure subjects may be 
re-screened at the discretion of the investigator and in consultation with the medical monitor 
as needed.  Any subject who discontinues participation or is withdrawn before receiving a 
treatment assignment, and who is re-screened at a later time will be assigned a new subject 
number and recorded as re-screened. 

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7 
STUDY TREATMENT(S)  
 
Treatments Administered  
Test articles will be supplied by Paratek Pharmaceuticals, Inc. (the sponsor).  Test articles 
will be labeled according to regulations. 
The test articles should be administered only to subjects who have provided pediatric assent 
(as appropriate per local regulations) and informed consent signed by his/her parent/LAR and 
who meet all of the inclusion criteria and none of the exclusion criteria.  Once the test article 
has been assigned to a subject, it must not be reassigned to another subject. 
Following a Screening period of up to 48 hours, eligible subjects will be assigned a dosing 
regimen of omadacycline per PI discretion.  
 
Identity of the Investigational Product:  Omadacycline  
Oral Formulation (Omadacycline) 
Administration 
Please reference Section 7.5 
Intravenous Formulation (Omadacycline) 
Administration 
Please reference Section 7.5 
 

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Dose Selection Rationale  
The dosing regimen of omadacycline selected for this study is based on the nonclinical and 
clinical experience to date, including in vitro antibacterial activity, PK characteristics and 
modeling, clinical efficacy in prior studies, the overall safety and tolerability profile, and the 
FDA approved dosing regimen for CABP and ABSSSI.  Based on interim PK and safety 
analyses, the dose could be modified during the study. 
This study will involve a single dose of either 100 mg IV or 300 mg oral omadacycline in a 
pediatric population in order to establish pediatric dosing as compared to adult subjects.  
 
Description of Treatments  
Subjects will be assigned to a single dose of either 100 mg intravenous omadacycline (in 
100 mL normal saline solution) infused over 30 minutes or 300 mg oral omadacycline (150 
mg tablet x 2). 
Eligible subjects will fall into one of the following treatment groups: 
Test Article Administration 
Adolescents 12 to < 18 years 
of age 
Children 8 to < 12 
years of age 
IV Omadacycline 
10 pts 
10 pts 
Oral Omadacycline 
10 pts 
10 pts 
 
Test Article Administration  
7.5.1 
Administration of Oral and IV Treatment  
Subjects will receive a single dose of either IV or oral test article on Day 1.  
Oral Omadacycline 
All doses of oral test article should be taken with water.    
All oral doses should be taken in a fasted state.  Fasting is defined as no food, antacids, or 
multivitamins containing multivalent cations (e.g., aluminum, magnesium, calcium, bismuth, 
iron, or zinc) or drink except water for at least 6 hours before dosing.  After dosing, no food 
is permitted for 2 hours and no dairy products, antacids, or multivitamins containing 
multivalent cations (e.g., aluminum, magnesium, calcium, bismuth, iron, or zinc) for 4 hours. 
IV Omadacycline 
Infusion of IV test article in 100 mL normal saline solution will be administered continuously 
over approximately 30 minutes.  Infusion start and stop times are to be recorded in the source 
documents and on the eCRF.   

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Dose Adjustments and Interruptions of Test Article  
No dose adjustments or planned interruptions of test article will be permitted during this 
study. 
7.6.1 
Subject Numbering  
Upon signing the informed consent and pediatric assent, the subject will be assigned a unique 
subject number.  Subjects who have been pre-screened, but who do not sign a pediatric 
assent/ICF will not be assigned a subject number.  A subject who discontinues participation 
or is withdrawn before receiving a treatment assignment, and who is re-screened at a later 
time will be assigned a new subject number and recorded as re-screened.  Re-screening is at 
the discretion of the investigator and in consultation with the medical monitor.  The 
investigator will maintain a subject master list to document every subject who has signed a 
pediatric assent and ICF.  A copy of this list should be retained in the investigator’s study 
files.  
 
Dispensing Test Article  
Each study site will be supplied by the sponsor with the investigational product.   
 
Prior and Concomitant Therapy  
Treatments that have been administered within the 72 hours prior to the date of informed 
consent and pediatric assent, or during the Screening phase, will be recorded in the eCRF.  
The investigator is to instruct the subject and his/her parent/LAR to notify the study site 
about any new medications he/she takes after the administration of the test article.  All 
medications and significant non-drug therapies (including physical therapy and blood 
transfusions) administered after the subject receives treatment with test article must be listed 
in the eCRF (see Section 8.15).   
 
Prohibited Therapy  
All investigational medications or devices used during the 30 days prior to Screening are 
prohibited.   
The following therapies are excluded: 
• Antacids and multivitamins containing multivalent cations (e.g., aluminum, 
magnesium, calcium, bismuth, iron, or zinc) for 6 hours before and within 4 hours 
after oral doses.  
 Permitted Treatments  
All other treatments not specified as prohibited are permitted during the study.  Treatment for 
infection under study is at the discretion of the investigator or the subject’s health care 
provider and will be considered as a concomitant medication. 

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Subjects or caregivers should be encouraged to contact site personnel before starting any new 
treatment. 
For all treatments received by the subject during the study, relevant information must be 
recorded on the subject’s eCRF. 
 Treatment Compliance  
Compliance and any unresolved discrepancies will be documented in the source document 
and on the drug inventory record.  The test article eCRF should reflect the reconciled dosing 
information provided by the subject charts.   
 Packaging and Labeling  
The investigational test article, omadacycline, will be packaged by the sponsor and supplied 
to the investigator.  
 Storage and Accountability  
Test article must be received at the study site by a designated person, handled and stored 
safely and properly, and kept in a secured location to which only the investigator and 
designated staff have access.  Upon receipt, the test article should be stored according to the 
instructions specified on the drug labels.  Storage conditions must be adequately monitored, 
and appropriate temperature logs maintained as source data. 
The designated study personnel must maintain an accurate record of the shipment and 
dispensing of test articles in the study-specific medication accountability ledger.  
 Investigational Product Retention at Study Site  
At the conclusion of the study, and as appropriate during the course of the study, with 
instruction from the sponsor, the designated study personnel will destroy test article on site as 
permitted by local site operating procedures, or return all unused test articles, packaging, and 
drug labels.  Destruction/return of all test article will be documented and maintained in the 
site files.   

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8 
STUDY PROCEDURES  
Written, signed, and dated informed consent will be obtained by subject’s parent/LAR before 
any study-related procedures have been performed.  Pediatric assent is also required as 
appropriate per local regulations.  Upon signing of the informed consent and pediatric assent, 
the subject will then be assigned a study subject number.  Adverse events (AEs) must be 
recorded from the time the ICF/pediatric assent is signed.  The investigator will maintain a 
subject master list to document every subject who has signed an ICF/pediatric assent.  A 
copy of this list should be retained in the investigator’s study files. 
 
Informed Consent and Pediatric Assent  
The investigator will provide for the protection of the subjects by following all applicable 
regulations.  These regulations are available upon request from the sponsor.  The ICF and 
pediatric assent must be reviewed by the sponsor and approved by the IRB/IEC/REB. 
Before any procedures specified in the protocol are performed, a subject and his/her 
parent/LAR must: 
• Be informed of all pertinent aspects of the study and all elements of informed consent 
and pediatric assent (when applicable)  
• Be given time to ask questions and time to consider the decision to participate 
• Voluntarily agree to participate in the study 
• Sign and date an IRB/IEC/REB approved ICF and pediatric assent (when applicable) 
 
Subject Demographics/Other Baseline Characteristics  
Subject demographic and Baseline characteristic data to be collected at screening on all 
subjects include  date of birth, gender, and race/ethnicity.   
 
Medical History  
The investigator will perform a comprehensive history at the Screening visit.  Significant 
medical history (at any time) and any medical history within the past 6 months including 
ongoing medical conditions at the time of signing of the ICF/assent will be recorded.   
Where possible, diagnoses are to be recorded.  Any event or change in the subject’s condition 
or health status occurring after signing the ICF will be reported as an AE. 
 
Physical Examination  
At Screening, a full physical examination will include the examination of general 
appearance, skin, neck, eyes, ears, nose, throat, lungs, heart, abdomen, lymph nodes, 
extremities, and brief neurological exam.   
Information for all physical examinations must be included in the source documentation at 
the study site.  Significant and relevant findings that are present prior to the start of test 

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article must be included in the subject’s eCRF.  Relevant findings that are present prior to the 
start of test article must be included in the relevant medical history/current medical 
conditions screen on the subject’s eCRF.  Significant findings made after the start of test 
article which meet the definition of an AE must be recorded on the AE screen of the subject’s 
eCRF. 
 
Vital Signs  
Vital signs (blood pressure [BP], heart rate [HR], and body temperature) will be measured at 
the timepoints indicated in the Schedule of Events (Appendix 1).  
The subject’s BP and heart rate at all time points should be captured after at least 5 minutes 
(+ 5 minutes) of rest while in a supine position.  
Systolic and diastolic BP will be measured using an automated calibrated device, with an 
appropriately sized cuff.  Heart rate will be measured using an automated calibrated device, 
when available.  If not available, heart rate will be measured manually.  
Temperature will be obtained using an electronic (rapid reading) device whenever possible.  
Temperature can be measured using the method preferred by the study site (e.g., oral, rectal, 
tympanic membrane, axillary).  Both the temperature and method of measurement will be 
captured in the eCRF. 
 
Height, Weight, and BMI  
Both height and body weight will be obtained with shoes off.  
 
Clinical Laboratory Tests  
All laboratory testing will be performed by the local laboratory at each site.  All hematology 
and serum chemistry parameters and blood tests outlined in Table 1 and Table 2 are required 
to be collected to determine study eligibility. Laboratory tests collected as part of standard of 
care within 24 hours of consent/assent may be used for determining eligibility and do not 
need to be repeated provided that all protocol required parameters have been collected.  
If any of the required parameters are not collected as part of standard of care testing, 
laboratory samples must be drawn and results obtained for missing parameters in order to 
determine subject eligibility.  
The relevant local laboratory results from Screening will be used to assess eligibility as per 
the inclusion/exclusion criteria. 
8.7.1 
Hematology and Serum Chemistry  
Blood testing will include the hematology and serum chemistry parameters as shown in 
Table 1 and Table 2, respectively.  These results for the study timepoints indicated in 
Appendix 1 will be recorded in the eCRF.   

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Table 1 
Hematology    
Hematocrit  
Hemoglobin 
Mean cell volume 
WBC count  
Platelet count  
White blood cell differential (as % cell counts) 
 
Neutrophils  
 
Lymphocytes  
 
Monocytes  
 
Eosinophils  
 
Basophils  
WBC = white blood cell 
 
Table 2 
Serum Chemistry    
Blood glucose  
Urea  
Creatinine 
Sodium 
Potassium 
Chloride 
Bicarbonate 
ALT 
AST 
AP 
Total bilirubin  
Total protein  
Albumin  
 
CK 
Calcium  
Phosphate  
Cholesterol  
Uric Acid 
GGT 
Amylase 
Lipase 
ALT = alanine aminotransferase, AP = alkaline phosphatase, AST = aspartate aminotransferase, 
CK = creatine phosphokinase, GGT = gamma-glutamyl transpeptidase 
 
8.7.2 
SARS-CoV-2 Sample  
Testing for SARS-CoV-2 will be performed in accordance with site’s standard of care and 
local policy.  
 
8.7.3 
Pregnancy Assessment  
Females of reproductive potential (post-menarchal or has reached Tanner Stage 3 breast 
development) will have a local laboratory urine or serum pregnancy test at Screening.  
Results are required for eligibility, retained in source documents,  and will be entered in the 
eCRF.  If a positive urine or serum pregnancy test result is obtained during Screening, the 
subject is not to be enrolled.   
 
Pharmacokinetic Assessments  
Instructions will be provided to sites with detailed information on sample collection, 
handling, and shipment requirements.  All samples will be given a unique identifier.  The 
exact clock time of dosing, date and time of last food intake, as well as actual sample 
collection date and time will be entered on the eCRF.  A total of 7 blood samples for 
pharmacokinetic analysis of oral omadacycline and 8 blood samples for iv omadacycline will 
be collected at specified time points prior to dosing and throughout the 48 hours from time of 
dosing.   

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8.8.1 
PK Blood Collection and Processing  
Blood Collection (plasma): 
Blood samples will be collected and analyzed for omadacycline concentration at the following 
times: 
Oral Treatment  
• At least 15 minutes prior to administration of oral omadacycline 300 mg and at 1-
hour (±5 minutes), 2 hours (±5 minutes), 3 hours (±5 minutes), 8 hours (±1 hr.), 24 
hours (±1 hr.) and 48 hours (±1 hr.) after dosing  
Intravenous Treatment  
• At least 15 minutes prior to infusion of IV omadacycline 100 mg, at 10 minutes (±5 
minutes) , 0.5-hour (±5 minutes), 1-hour (±5 minutes), 2 hours (±5 minutes), 8 hours 
(±1 hr.), 24 hours (±1 hr.)  and 48 hours (±1 hr.) after the end of the IV infusion Storing 
and Shipping of PK Samples 
After all PK samples from a single subject have been collected and frozen at -20°C or colder, 
the primary samples from each time point can be batched together and carefully packaged 
and shipped frozen at -20°C or colder to the central laboratory designated by the sponsor.  
Samples are to be shipped with sufficient dry ice to remain frozen during overnight transit.   
 
Adverse Events  
An AE is any untoward, undesired, or unplanned event in the form of signs, symptoms, 
disease, or laboratory or physiologic observations occurring in a person given a test article or 
in a clinical study.  The event does not need to be causally related to the test article or clinical 
study.  An AE includes, but is not limited to, the following: 
• Any clinically significant worsening of a preexisting condition. 
• An AE occurring from overdose of a test article, whether accidental or intentional.  
Overdose is a dose greater than that specified in the protocol. 
• An AE occurring from abuse (e.g., use for nonclinical reasons) of a test article. 
• An AE that has been associated with the discontinuation of the use of a test article. 
 Serious Adverse Events  
A serious adverse event (SAE) is an AE that: 
• Results in death 
• Is life-threatening (see below) 
• Requires hospitalization or prolongation of an existing hospitalization (see below) 
• Results in a persistent or significant disability or incapacity (see below) 
• Results in a congenital anomaly or birth defect 

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• Additionally, important medical events that may not result in death, be life-threatening, 
or require hospitalization may be considered SAEs when, based on appropriate medical 
judgment, they may jeopardize the subject and may require medical or surgical 
intervention to prevent any 1 of the outcomes listed above in this definition.  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 hospitalization, or 
development of drug dependency or drug abuse. 
Life-threatening refers to immediate risk of death as the event occurred per the reporter.  A 
life-threatening experience does not include an experience, had it occurred in a more severe 
form, might have caused death, but as it actually occurred, did not create an immediate risk 
of death.  For example, hepatitis that resolved without evidence of hepatic failure would not 
be considered life-threatening, even though hepatitis of a more severe nature can be fatal.  
Similarly, an allergic reaction resulting in angioedema of the face would not be 
life-threatening, even though angioedema of the larynx, allergic bronchospasm, or 
anaphylaxis can be fatal. 
Hospitalization is official admission to a hospital.  Hospitalization or prolongation of a 
hospitalization constitutes criteria for an AE to be serious; however, it is not in itself 
considered an SAE.  In absence of an AE, a hospitalization or prolongation of a 
hospitalization should not be reported as an SAE by the participating investigator.  This is the 
case in the following situations: 
• The hospitalization or prolongation of hospitalization is needed for a procedure required 
by the protocol. 
• The hospitalization or prolongation of hospitalization is part of a routine procedure 
followed by the center (e.g., stent removal after surgery).  This should be recorded in the 
study file. 
• A hospitalization for a preexisting condition that has not worsened.  
Disability is defined as a substantial disruption in a person’s ability to conduct normal life 
functions. 
If there is any doubt about whether the information constitutes an SAE, the information is 
treated as an SAE. 
 Other Reportable Information  
Certain information, although not considered an SAE, must be recorded, reported, and 
followed up as indicated for an SAE.  This includes: 
• Pregnancy exposure to a test article:    Information about pregnancy exposure includes 
the entire course of pregnancy and delivery, and perinatal and neonatal outcomes, even if 
there are no abnormal findings.  Both maternal and paternal exposures are considered 
other reportable information.  For exposure involving the female partner of a male 
subject, the necessary information must be collected from the subject, while respecting 
the confidentiality of the partner. 

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• Lactation exposure to a test article with or without an AE. 
• Overdose of a test article as specified in this protocol with or without an AE. 
• Inadvertent or accidental exposure to a test article with or without an AE. 
 Overdose  
Any administration of omadacycline of greater than 100 mg intravenously or 300 mg orally 
within a 24-hour period will be an overdose, regardless of whether the overdose is intentional 
or accidental, it is a reportable event and the sponsor must be notified within 1 business day.  
The site personnel will retain this confirmation report.  
The physician managing the overdose may order any test he/she thinks is necessary to 
manage the subject properly. 
 Medication Errors  
Medication errors are the result of administration or consumption of the wrong product, by 
the wrong subject, at the wrong time, and/or by the wrong administration route, due to human 
error.   
Medication errors include, but are not limited to, the following: 
• The administration and/or consumption of test article that has not been assigned to the 
subject 
• Administration of expired test article 
All AEs and SAEs must be handled as specified in this protocol whether or not they are 
associated with a medication error.  A medication error associated with an SAE (including 
overdose, inadvertent exposure, and/or accidental exposure) will be reported with the SAE on 
the SAE Report Form.  All other medication errors will be reported by e-mailing the Other 
Reportable Events Report Form as indicated in the Emergency Contacts (see Section 2). 
 Recording and Reporting  
A subject’s AEs and SAEs will be recorded and reported from the signing of the ICF/assent 
to the time of the Study Completion visit.  The investigator must instruct the subject and 
his/her parent/LAR to report AEs and SAEs during this time period.  Reports of death within 
30 days after the last contact with the subject will be reported to the sponsor and additional 
information relative to the cause of death will be sought and documented.   
All AEs and SAEs must be recorded on source documents.  All AEs and SAEs for subjects 
who receive a treatment assignment will be recorded in the eCRFs. 
The investigator must follow-up as medically necessary on all AEs and SAEs until the events 
have subsided, the condition has returned to Baseline, or in case of permanent impairment, 
until the condition stabilizes. 

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Adverse events should be based on the signs or symptoms detected during the physical 
examination and on clinical evaluation of the subject.  In addition to the information obtained 
from those sources, the subject should be asked the following nonspecific question:  "How 
have you been feeling since your last visit?"  Whenever possible, AEs should be reported as a 
diagnosis rather than individual signs and symptoms.  If a definitive diagnosis is not possible, 
the individual signs and symptoms should be recorded using standard medical terminology. 
If an AE requires a surgical or diagnostic procedure, the illness leading to the procedure 
should be recorded as the AE, not the procedure itself. 
Death should be recorded in the eCRF as an outcome of an AE.  Any unanticipated risks to 
the subjects must be reported promptly to the IRB/IEC/REB.  
8.14.1 
Serious Adverse Event Reporting  
All SAEs and follow-up information must be reported within 1 business day or 24 hours as 
required by local regulations by emailing a completed SAE Report to the email address 
below.  
Serious Adverse Event (SAE) contact information: 
E-Mail: 
 
8.14.2 
Assessment of Relatedness  
The investigator will assess causality (i.e., whether there is a reasonable possibility that test 
article caused the event) for all AEs and SAEs.  The relationship will be characterized using 
the following classification: 
• Not related:  This relationship suggests that there is no association between test article 
and the reported event.  The event can be explained by other factors such as an 
underlying medical condition, concomitant therapy, or accident, and no plausible 
temporal or biologic relationship exists between test article and the event. 
• Related:  This relationship suggests that a definite causal relationship exists between test 
article administration and the AE, or there is a reasonable possibility that the event was 
caused by the study medication, and other conditions (concurrent illness, 
progression/expression of disease state, or concurrent medication reaction) do not appear 
to explain the event. 
Adverse events and SAEs also will be assessed for their potential relationship to the protocol.  
A protocol-related AE is one that is not related to the test article but is considered by the 
investigator or the medical monitor (or designee) to be related to the research conditions, i.e., 
related to the fact that a subject is participating in the study.  For example, a protocol-related 
AE may be an untoward event related to a medical procedure required by the protocol. 
8.14.3 
Assessment of Severity  
The severity (or intensity) of an AE will be classified using the following criteria: 

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• Mild:  These events are usually transient, require minimal or no treatment, and do not 
interfere with the subject’s daily activities. 
• Moderate:  These events result in a low level of inconvenience or concern with the 
therapeutic measures.  Moderate events may cause some interference with normal 
functioning but pose no significant or permanent risk of harm. 
• Severe:  These events interrupt a subject’s usual daily activity and may require systemic 
drug therapy or other treatment.  Severe events are usually incapacitating. 
Changes in the severity of an AE should be documented as a new event to allow an 
assessment of the duration of the event at each level of intensity to be performed. 
8.14.4 
Laboratory Findings  
Protocol-defined safety laboratory test results will be analyzed as part of specific laboratory 
safety analyses.  Additional laboratory test results at other time points may be available to the 
investigator as part of standard clinical practice.  Throughout the study, laboratory-related 
abnormalities should be recorded as AEs only if considered clinically significant, outside the 
range of expected values given the subject’s Baseline assessments and clinical course, and 
not known to be part of another AE diagnosis. 
8.14.5 
Pregnancies  
To ensure subject safety, each pregnancy in a subject on test article must be reported to the 
sponsor within 1 business day of learning of its occurrence.  Test article should be 
discontinued immediately, and the pregnancy should be followed up to determine outcome, 
including spontaneous or voluntary termination, details of the birth, and the presence or 
absence of any birth defects, congenital abnormalities, or maternal and/or newborn 
complications. 
Pregnancy should be recorded on a Clinical Trial Pregnancy Form and reported by the 
investigator to the sponsor.  Pregnancy follow-up should be recorded on the same form and 
should include an assessment of the possible relationship to the test article of any pregnancy 
outcome.  Any SAE experienced during pregnancy must be reported on the SAE Report 
Form. 
 Concomitant Medication Assessments  
The investigator should instruct the subject and his/her parent/LAR to notify the study site 
about any new medications they take after the start of the test article.   
All prescription medications, over-the-counter drugs, and recreational drugs taken within the 
timeframe defined in the entry criteria prior to the start of the study and during the study, 
must be recorded on the Concomitant Medications/Non-Drug Therapies page of the eCRF.  
Medication entries should be specific to trade name, the single dose and unit, the frequency 
and route of administration, the start and discontinuation dates, and the reason for therapy. 

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 Subject Discontinuation or Withdrawal  
Reasons why a subject may discontinue or be withdrawn from the study include, but are not 
limited to, AE, lost to follow-up, withdrawal by subject, physician decision, death, and other 
(specify reason e.g., subject non-compliance or study termination by the sponsor).  Subjects 
may voluntarily withdraw from the study for any reason at any time.  Subjects are considered 
withdrawn from the study if they state an intention to withdraw, or fail to return for visits, or 
become lost to follow-up for any other reason.  If premature withdrawal from the study 
occurs for any reason, the investigator should determine the primary reason for a subject’s 
premature withdrawal from the study and record this information on the eCRF.  
For subjects who are lost to follow-up, the investigator should show "due diligence" by 
documenting in the source documents steps taken to contact the subject, e.g., dates of 
telephone calls, registered letters, etc. 
8.16.1 
Replacements  
Any subject who is withdrawn or discontinued from the study may be replaced at the 
discretion of the sponsor to meet the target of at least 24 subjects with complete PK 
sampling. 

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9 
STUDY ACTIVITIES  
The full assessment schedule is presented in the Schedule of Events (see Appendix 1).  
Subjects should be seen for all assessments and visits on the designated time and day.   
 
Screening Phase  
The Screening visit should be completed within a 48-hour period prior to enrollment and 
dosing.  The Screening procedures will be used to establish subject eligibility and Baseline 
characteristics for each subject.  Following the signing of an ICF/pediatric assent, the site 
staff will collect/perform the assessments detailed in Appendix 1. 
 
Treatment Phase  
The open label treatment period is a single dose administered on one day.   
 
Study Completion Visit Procedures  
The Study Completion evaluation should be conducted 4 to 7 days after dosing.  This visit 
may be performed via telehealth with subject’s parent/LAR to review ongoing medications 
and adverse events if the subject is discharged from the hospital before Day 4.  

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10 STUDY SUSPENSION, TERMINATION, AND COMPLETION  
 Study Completion and Post-Study Test Article  
A subject will have successfully completed the study after the planned test article regimen 
has been administered, and all assessments and visits have been performed up through the 
Study Completion Visit.  The study will be completed when the last subject has either 
discontinued or completed the Study Completion Visit.   
No long-term follow-up of subjects is planned, with the exception of pregnancies, as 
described in Section 8.14.5, and SAEs described in Section 8.10. 
Sites will be notified by the Sponsor to stop enrollment when the desired number of treated 
subjects have been enrolled.  Subjects already consented, but not yet assigned will be allowed 
to continue Screening procedures. 
Upon study completion, the investigator will provide the sponsor, IRB/IEC/REB, and 
regulatory agency with final reports and summaries as required by regulations.  The 
investigator must submit a written report to the sponsor and the IRB/IEC/REB within 
3 months after the completion or termination of the study. 
 Study Suspension or Termination  
The sponsor may suspend or terminate the study at any time for any reason.  Should this be 
necessary, subjects should be seen as soon as possible and treated as described in 
Sections 9.3 and 8.16.  The investigator may be informed of additional procedures to be 
followed in order to ensure that adequate consideration is given to the protection of the 
subject’s interests.  The investigator will be responsible for informing IRBs and/or Ethics 
Committees (ECs) of the early termination of the study. 
If the investigator suspends or prematurely terminates their participation in the study, the 
investigator will promptly inform the sponsor and the IRB/IEC/REB and provide them with a 
detailed written explanation.  Subjects should be seen as soon as possible and treated as 
described in Sections 8.16 and 9.3 for prematurely withdrawn subjects.  The investigator will 
also return all test articles, containers, and other study materials to the sponsor. 

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11 QUALITY CONTROL AND ASSURANCE  
The sponsor performs quality control and assurance checks on all clinical studies that it 
sponsors.  Before enrolling any subjects in this study, sponsor personnel and the investigator 
review the protocol, the Investigator’s Brochure, the  eCRFs and instructions for their 
completion, the procedure for obtaining informed consent/assent, and the procedure for 
reporting AEs and SAEs.  A qualified representative of the sponsor monitors the conduct of 
the study by visiting the site and by contacting the site by telephone and e-mail.  During these 
site visits, information recorded in the eCRFs is verified against source documents. 

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12 PLANNED STATISTICAL METHODS  
 General Considerations  
This section describes the statistical analysis as foreseen at the time of planning the study.  
Changes, additions, and further details about the analyses will be described in the statistical 
analysis plan (SAP).  After finalization of the SAP, any additional analyses or changes to 
analyses that may be required will be fully disclosed in the Clinical Study Report (CSR). 
Analyses will be performed after the database lock at which all eCRFs are completed, 
entered and source data verified; all safety laboratory results have been reported; all AEs 
fully characterized (e.g., relationship to test article determined) and coded; characterization 
of protocol deviations as major/minor completed, and all queries have been resolved.    
Exploratory analyses may also be performed.  Listings of individual subject’s data will be 
produced. 
 Determination of Sample Size  
The sample size selected is based on an estimation approach rather than a formal hypothesis 
testing approach.  An estimation approach with 20 subjects in each age cohort (10 subjects 
per treatment, per age cohort) will be enrolled.  A total of 40 subjects will be enrolled so that 
at least 24 subjects are evaluable for PK parameter estimation (with a minimum of 6 subjects 
per treatment, per age cohort). 
 Analysis Populations  
Safety Population:  The safety population will consist of all assigned subjects who received 
study drug. 
PK Evaluable Population:  The PK population will include subjects who receive study drug 
and have at least 1 evaluable PK parameter.  If any subject has an emesis within 2.5x median 
Tmax after dosing, the subject may be excluded from PK population. 
 Interim Analysis  
Interim PK and safety analyses will be conducted as data become available to allow for 
dosing modifications and/or sample size adaptation.  
 Review of Safety Data  
Due to the open-label design, safety review and analysis of PK samples will be performed on 
an ongoing basis by the sponsor. The sponsor study team, including physician and 
pharmacokineticist, will be part of the review. Safety review will occur at the completion of 
each subject individually and collectively (all subjects) to identify trends, quality concerns 
and any safety issues. Reviews will include PK analyses, treatment-emergent adverse events, 
SAEs, clinical laboratory results, vital sign measurements and Physical Examination 

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findings. PK data will also be reviewed at periodic intervals and compared to the established 
PK profile in adults.   
 
Based on the reviews, the study may continue as planned, the protocol may be amended to 
include additional safety evaluations or to adjust the dosing, or the study may be paused or 
stopped. 
 
 Demographics and Baseline Characteristics  
Demographics (including age, gender, and race/ethnicity) and baseline characteristics will be 
summarized.  Descriptive statistics of the duration of test article treatment will be provided.  
The number and percentage of subjects who prematurely discontinued test article and the 
reason for discontinuation and the number and percentage of subjects prematurely 
discontinuing the study and the primary reason for discontinuation will be presented. 
 Primary Endpoints  
12.7.1 
Pharmacokinetic Endpoint  
Concentration and time deviation data will be presented in data listings.  Plasma 
concentration data will be summarized by scheduled time point for each treatment using 
descriptive statistics (number of subjects, mean, standard deviation [SD], coefficient of 
variation [CV], median, minimum, and maximum).  Mean and individual plasma 
concentration versus time profiles will be presented in figures on both linear and 
semilogarithmic scales. 
Noncompartmental PK parameters will be determined from plasma concentration and actual 
time data using Phoenix® WinNonlin® (Certara, Princeton, New Jersey) Version 8.0 or 
higher or a WinNonlin validated statistical analysis system (SAS) program.  
The following plasma PK parameters will be determined: 
• 
Area under the plasma concentration versus time curve (AUC) from time 0 to 
48hours after dosing (AUC0-48) 
• 
AUC from time 0 to the last quantifiable concentration (AUClast) 
• 
AUC from time 0 extrapolated to infinity (AUC0-inf) 
• 
Maximum observed plasma concentration (Cmax) 
• 
Time to reach maximum observed plasma concentration (Tmax) 
• 
Elimination half-life associated with the terminal slope of the semilogarithmic 
concentration-time curve (T1/2) 
• 
Apparent volume of distribution (Vd) after iv administration only 
• 
Systemic clearance (CL) after iv administration only 

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Additional exploratory PK calculations may be performed and will be described in the 
statistical analysis plan. 
For the PK analysis, below the limit of quantification (BLQ) values before the first 
quantifiable concentration will be treated as zero.  Below the limit of quantification values 
after the first quantifiable concentration will be set as missing.  Missing concentrations will 
be treated as missing.  If consecutive BLQ concentrations are followed by quantifiable 
concentrations in the terminal phase, those concentrations after BLQ concentrations will be 
treated as missing. 
For concentration summary statistics, BLQ values before the first quantifiable concentration 
will be treated as zero.  Below the limit of quantification values after the first quantifiable 
concentration will be set as missing.  Missing concentrations will be treated as missing. 
The individual PK parameters of omadacycline will be presented in data listings.  Descriptive 
statistics (number of subjects, mean, SD, CV, median, minimum, and maximum) will be 
calculated for the PK parameter estimates for each period (e.g., AUC from time 0 to 48 hours 
after dosing [AUC0-48], AUC from time 0 to the last quantifiable concentration [AUClast], 
AUC from time 0 extrapolated to infinity [AUC0-inf], maximum observed plasma 
concentration [Cmax], time to reach maximum observed plasma concentration [Tmax], 
clearance [CL] (iv arm only), apparent volume of distribution [Vd] (iv arm only) and T1/2, 
from plasma concentrations).  Geometric means will be included for AUC0-48, AUC0-inf, and 
Cmax. 
Any additional exploratory PK calculations will be further described in the SAP. 
 Secondary Endpoints  
12.8.1 
Safety Endpoints  
The safety data will be summarized by treatment where applicable.  The incidence of 
treatment-emergent AEs will be presented by treatment, system organ class, and preferred 
term according to the Medical Dictionary for Regulatory Activities (MedDRA), relationship 
to the study drug, and severity.  Any SAEs and AEs leading to discontinuation of study drug 
will also be presented in a data listing. 
Clinical laboratory test results, vital sign measurements, and physical examination findings 
will be presented in data listings.  Actual results and changes from Baseline for vital sign 
measurements and clinical laboratory test results will be summarized by treatment and time 
point. 
Prior and concomitant medications and therapies will be coded using the latest version of the 
World Health Organization Drug Dictionary and will be presented in a data listing. 

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 Data Handling Conventions  
Concentrations that are BLQ before the first quantifiable concentration will be treated as zero 
for descriptive statistics.  Below the limit of quantification values after the first quantifiable 
concentration will be set as missing and excluded for summary statistics.  Mean BLQ 
concentrations will be presented as BLQ, and the SD and CV will be reported as not 
applicable, if all individual values are BLQ. If consecutive BLQ concentrations are followed 
by quantifiable concentrations in the terminal phase, those concentrations after BLQ 
concentrations will be treated as missing. 
 Multiple Comparisons and Multiplicity  
No formal comparisons are planned. 
 General Data Summaries  
For continuous variables, descriptive statistics (number [n], mean, SD, median, minimum, 
and maximum) will be provided.  
For categorical variables, patient counts, and percentages will be provided.  Categories for 
missing data will be presented if necessary. 

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13 ADMINISTRATIVE CONSIDERATIONS  
 Investigators and Study Administrative Structure  
See Section 13.5.1 for Investigator responsibilities for data handling, access and record 
keeping. 
 Institutional Review Board or Independent Ethics Committee Approval  
The protocol and the proposed ICF and pediatric assent must be reviewed and approved by a 
properly constituted IRB/IEC/REB before study start.  A signed and dated statement that the 
protocol, ICF and pediatric assent have been approved by the IRB/IEC/REB must be given to 
the sponsor before study initiation.  Prior to study start, the investigator is required to sign a 
protocol signature page confirming his/her agreement to conduct the study in accordance 
with these documents and all of the instructions and procedures found in this protocol and to 
give access to all relevant data and records to the sponsor, monitors, auditors, designated 
agents of the sponsor, IRBs/IECs/REBs, and regulatory authorities as required.  If an 
inspection of the clinical site is requested by a regulatory authority, the investigator must 
inform the sponsor immediately that this request has been made.   
 Ethical Conduct of the Study  
This clinical study was designed and shall be implemented and reported in accordance with 
the International Council on Harmonization (ICH) Harmonized Tripartite Guidelines for 
Good Clinical Practice (GCP), with applicable local regulations (including European 
Directive 2001/20/EC, US 21 Code of Federal Regulations (CFR), and Japanese Ministry of 
Health, Labor, and Welfare), and with the ethical principles laid down in the Declaration of 
Helsinki. 
 Patient Information and Consent  
The investigator will provide for the protection of the subjects by following all applicable 
regulations.  These regulations are available upon request from the sponsor.  The ICF and 
pediatric assent must be reviewed by the sponsor and approved by the IRB/IEC/REB. See 
Section 8.1 for further detail on Patient Information and Consent requirements. 
 Direct Access, Data Handling, and Record Keeping  
13.5.1 
Investigator  
The investigator will permit study-related monitoring, audits, IRB/IEC/REB review, and 
regulatory inspections by providing direct access to source data and documents. 
All information will be recorded on source documents.  All required data will be recorded in 
the eCRFs. 

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If an investigator retires, relocates, or otherwise withdraws from conducting the study, the 
investigator must notify the sponsor to agree upon an acceptable storage solution.  
Regulatory agencies will be notified with the appropriate documentation. 
An updated form 1572 will be filed with the sponsor for any changes in the study personnel 
reported in the current form 1572. 
13.5.2 
Sponsor  
The data is entered into an electronic database via eCRFs.  The Sponsor Medical Monitor 
reviews the data for safety information.  The data is reviewed for completeness and logical 
consistency.  Automated validation checks identify missing data, out-of-range data, and other 
data inconsistencies.  Requests for data clarification are forwarded to the investigative site for 
resolution. 
 Protocol Adherence  
13.6.1 
Violations/Deviations  
Investigators will agree to apply due diligence to avoid protocol deviations.  Under no 
circumstances should the investigator contact the sponsor or its agents to request approval of 
a prospective protocol deviation, as no authorized deviations are permitted.  If the 
investigator feels a protocol deviation would improve the conduct of the study this must be 
considered a protocol amendment, and unless such an amendment is agreed upon by the 
sponsor and approved by the IRB/IEC/REB, it cannot be implemented.  All significant 
protocol deviations will be recorded and reported in the CSR. 
13.6.2 
Protocol Amendments  
Any change or addition to the protocol can only be made in a written protocol amendment 
that must be approved by the sponsor, Health Authorities where required, and the 
IRB/IEC/REB.  Only amendments that are required for subject safety may be implemented 
prior to IRB/IEC/REB approval.  Notwithstanding the need for approval of formal protocol 
amendments, the investigator is expected to take any immediate action required for the safety 
of any subject included in this study, even if this action represents a deviation from the 
protocol.  In such cases, the sponsor should be notified of this action and the IRB/IEC/REB 
at the study site should be informed within 10 working days. 
 Subject Injury  
In general, subject to specific provisions in the clinical study agreement (CSA), if a subject is 
injured as a direct result of a test article, the sponsor will pay for reasonable and necessary 
medical treatment for the injury, to the extent that such expenses are not covered by the 
subject’s medical insurance, a government program, or other responsible third party.  If laws 
or regulations of the locality in which the study is taking place require additional payment of 
expenses, the sponsor shall comply with such laws or regulations.  Where applicable, the 
sponsor has taken specific national insurance. 

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 Pre-Study Documentation  
The investigator must provide the sponsor with the following documents before enrolling any 
subjects: 
• Completed and signed form 1572 or equivalent 
• All applicable country-specific regulatory forms 
• Current signed and dated curricula vitae for the investigator, sub-investigators, and other 
individuals having significant investigator responsibility who are listed on the 
form 1572 or equivalent, or the clinical study information form 
• Copy of the IRB/IEC/REB approval letter for the protocol and informed consent and 
pediatric assent.  All advertising, recruitment, and other written information provided to 
the subject must be approved by the IRB/IEC/REB.  Written assurance of continuing 
approval (at least annually) as well as a copy of the annual progress report submitted to 
the IRB/IEC/REB must also be provided to the sponsor.   
• Copy of the IRB/IEC/REB-approved informed consent and pediatric assent documents to 
be used 
• Where applicable, a list of the IRB/IEC/REB members and their qualifications, and a 
description of the committee’s working procedure 
• Copy of the protocol sign-off page signed by the investigator 
• Fully executed CSA 
• Where applicable, a financial disclosure form 
• A written document containing the name, location, certification number, and date of 
certification of the laboratories to be used for laboratory assays and those of other 
facilities conducting tests.  This document should be returned along with the statement of 
investigator form.  The sponsor must be notified if the laboratory is changed or if any 
additional laboratory is to be used.  
• List of normal laboratory values and units of measure for all laboratory tests required by 
the protocol.  This is required for each laboratory to be used during the study.  The 
sponsor must be notified if normal values or units of measurement change. 
 Retention of Data  
The investigator shall retain and preserve 1 copy of all data generated in the course of the 
study, specifically including but not limited to those defined by GCP as essential, for the 
longer of: (a) 2 years after the last marketing authorization for the investigational test article 
has been approved or the sponsor has discontinued its research with respect to such 
investigational test article or (b) such longer period as required by applicable global 
regulatory requirements.  At the end of such period, the investigator shall notify the sponsor 
in writing of its intent to destroy all such material.  The sponsor shall have 30 days to 
respond to the investigator’s notice, and the sponsor shall have a further opportunity to retain 
such materials at the sponsor’s expense. 

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 Publication and Disclosure Policy  
The sponsor assures that the key design elements of this protocol will be posted in a publicly 
accessible database such as clinicaltrials.gov.  In addition, upon study completion and 
finalization of the study report, the results of this study will be either submitted for 
publication and/or posted in a publicly accessible database of clinical study results. 
Upon completion of the study, the investigator may publish the results in recognized 
(refereed) scientific journals subject to the provisions of the CSA.  Unless otherwise 
specified in the CSA, the following process shall occur: 
The institution and PI shall not publish or present data from an individual study center until 
the complete multi-center study has been presented in full or for 2 years after the termination 
of the multi-center study, whichever occurs first.  Subsequent publications must refer to the 
multi-center findings.  Thereafter, if the PI expects to participate in the publication of data 
generated from this site, the institution and PI shall submit reports, abstracts, manuscripts, 
and/or other presentation materials to the sponsor for review before submission for 
publication or presentation.  The sponsor shall have 60 days to respond with any requested 
revisions, including, without limitation, the deletion of confidential information.  The PI shall 
act in good faith upon requested revisions, except that the PI shall delete any confidential 
information from such proposed publication.  The PI shall delay submission of such 
publication or presentation materials for up to an additional 90 days in order to have a patent 
application(s) filed. 

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14 REFERENCE LIST  
 
1 Investigator’s Brochure 

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Appendix 1. Schedule of Assessments  
 
 
Schedule of Assessments – Intravenous Treatment Arm 
Study Phase 
Screeninga 
 
 
IV Treatment Period  
 
Study 
Completionb 
Study Day 
D –2 to D–
1 
D1 
D2 
D3 
D4-D7 
 
 
 
 
Post Dose Timepoint 
 
Study Timepoint 
–48 hrs. 
Pre-
dosec 
Infusion 
10 
Min.  
0.5 
Hr.  
1 Hr.  
2 Hrs. 
8 Hrs. 
24 Hrs. 
48 Hrs. 
 
Informed consent 
Xd 
 
 
 
 
 
 
 
 
 
 
Assent (as 
required/permitted) 
Xd 
 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion 
criteria 
X 
X 
 
 
 
 
 
 
 
 
 
Medical history/current 
medical conditions 
X 
 
 
 
 
 
 
 
 
 
 
Demography 
X 
 
 
 
 
 
 
 
 
 
 
Physical examinatione 
X 
 
 
 
 
 
 
 
X 
 
 
Height & Weight 
Xf 
 
 
 
 
 
 
 
 
 
 
Serum or urine 
pregnancy testg 
X 
 
 
 
 
 
 
 
 
 
 
Vital signs (BP & HR)h 
X 
X 
 
 
 
X 
 
X 
X 
 
 
Temperature 
X 
X 
 
 
 
 
 
 
X 
 
 
Hematology 
Xi 
 
 
 
 
 
 
 
X 
 
 
Serum chemistry 
Xi 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Schedule of Assessments – Intravenous Treatment Arm 
Study Phase 
Screeninga 
 
 
IV Treatment Period  
 
Study 
Completionb 
Study Day 
D –2 to D–
1 
D1 
D2 
D3 
D4-D7 
 
 
 
 
Post Dose Timepoint 
 
Study Timepoint 
–48 hrs. 
Pre-
dosec 
Infusion 
10 
Min.  
0.5 
Hr.  
1 Hr.  
2 Hrs. 
8 Hrs. 
24 Hrs. 
48 Hrs. 
 
Study drug 
administrationj 
 
 
X 
 
 
 
 
 
 
 
 
PK blood collection 
 
X 
 
X 
X 
X 
X 
X 
X 
X 
 
Adverse eventsk 
< ----------------------------------------------------------------------- X ------------------------------------------------------------------------ > 
Prior/concomitant 
medicationsl 
< ----------------------------------------------------------------------- X ------------------------------------------------------------------------ > 
 
 
BMI = body mass index, BP = blood pressure, D = study day, HR = heart rate, ICF = informed consent form, PK = 
pharmacokinetic 
a 
Screening period of up to 48 hours is permitted. 
b 
Study completion visit may be performed via telehealth with subject’s parent/LAR to review ongoing medications and 
adverse events if the subject is discharged from the hospital before Day 4.  
c 
Pre-dose window is defined as after consent and at least 15 minutes prior to study drug administration. 
d      Written and signed ICF/assent as applicable must be obtained before any protocol-specific assessment is performed. 
e 
Full physical examination to be performed at Screening and 24 hours post-dose.  Symptom-driven physical exams may be 
performed at other timepoints as necessary. 
f 
Both height and weight to be obtained with shoes off. 
g 
For post-menarchal females of childbearing potential or females who have reached Tanner Stage 3 of breast development 
only. 
h 
Blood pressure and heart rate to be performed after at least 5 minutes of rest while in supine position. 
i 
Blood samples for hematology and chemistry will be assessed by site’s local laboratory.  If standard of care laboratory 
assessments were performed within 24 hours prior to consent/assent, these results may be used for purposes of 
determining eligibility provided they meet protocol requirements for all screening labs. Refer to Section 8.7. 

Omadacycline 
Paratek Pharmaceuticals, Inc. 
PTK0796-PEDPK-20110 Version .0 FINAL; -14-Sep-2023 
 
IND No. 75,928 IND No. 73,431 
 
Confidential and Proprietary 
 
Page 48 of 52 
 
 
Schedule of Assessments – Intravenous Treatment Arm 
Study Phase 
Screeninga 
 
 
IV Treatment Period  
 
Study 
Completionb 
Study Day 
D –2 to D–
1 
D1 
D2 
D3 
D4-D7 
 
 
 
 
Post Dose Timepoint 
 
Study Timepoint 
–48 hrs. 
Pre-
dosec 
Infusion 
10 
Min.  
0.5 
Hr.  
1 Hr.  
2 Hrs. 
8 Hrs. 
24 Hrs. 
48 Hrs. 
 
j 
IV study drug infusion should be administered at room temperature continuously over 30 minutes. 
k 
Adverse events will be assessed from the time of signing the consent/assent until the study completion visit. 
l 
All medications taken within 72 hours prior to signing of consent/assent will be collected, in addition to all medications 
taken during the study. 

Omadacycline  
Paratek Pharmaceuticals, Inc. 
PTK0796-PEDPK-20110 Version 5.0 FINAL; -14-Sep-2023 
 
 
 
 
IND No. 75,928 IND No. 73,431 
 
Confidential and Proprietary 
 
Page 49 of 52 
 
Schedule of Assessments – Oral Treatment Arm 
Study Phase 
Screeninga 
 
Oral Treatment Period 
 
Study 
Completionb 
Study Day 
D –2 to D–1 
D1 
D2 
D3 
D4-D7 
 
 
 
Post Dose Timepoint 
 
Study Hour 
–48 hrs. 
Pre-
dosec 
0  
1 Hr. 
2 Hrs. 
3 Hrs. 
8 Hrs. 
24 Hrs. 
48 Hrs. 
 
Informed consent 
Xd 
 
 
 
 
 
 
 
 
 
Assent (as 
required/permitted) 
Xd 
 
 
 
 
 
 
 
 
 
Inclusion/exclusion criteria 
X 
X 
 
 
 
 
 
 
 
 
Medical history/current 
medical conditions 
X 
 
 
 
 
 
 
 
 
 
Demography 
X 
 
 
 
 
 
 
 
 
 
Physical examinatione 
X 
 
 
 
 
 
 
X 
 
 
Height & Weight 
Xf 
 
 
 
 
 
 
 
 
 
Serum or urine pregnancy 
testg 
X 
 
 
 
 
 
 
 
 
 
Vital signs (BP & HR)h 
X 
X 
 
 
X 
 
X 
X 
 
 
Temperature 
X 
X 
 
 
 
 
 
X 
 
 
Hematology 
Xi 
 
 
 
 
 
 
X 
 
 
Serum chemistry 
Xi 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Study drug administrationj 
 
 
X 
 
 
 
 
 
 
 
PK blood collection 
 
X 
 
X 
X 
X 
X 
X 
X 
 
Adverse eventsk 
< -----------------------------------------------------------------X ----------------------------------------------------------------------------------- > 
Prior/concomitant 
medicationsl 
< ---------------------------------------------------------------- X ---------------------------------------------------------------------------------- > 

Omadacycline  
Paratek Pharmaceuticals, Inc. 
PTK0796-PEDPK-20110 Version 5.0 FINAL; -14-Sep-2023 
 
 
 
 
IND No. 75,928 IND No. 73,431 
 
Confidential and Proprietary 
 
Page 50 of 52 
 
Schedule of Assessments – Oral Treatment Arm 
Study Phase 
Screeninga 
 
Oral Treatment Period 
 
Study 
Completionb 
Study Day 
D –2 to D–1 
D1 
D2 
D3 
D4-D7 
 
 
 
Post Dose Timepoint 
 
Study Hour 
–48 hrs. 
Pre-
dosec 
0  
1 Hr. 
2 Hrs. 
3 Hrs. 
8 Hrs. 
24 Hrs. 
48 Hrs. 
 
 
BMI = body mass index, BP = blood pressure, D = study day, HR = heart rate, ICF = informed consent form, PK = pharmacokinetic 
a 
Screening period of up to 48 hours is permitted. 
b 
Study completion visit may be performed via telehealth with subject’s parent/LAR to review ongoing medications and adverse events if 
the subject is discharged from the hospital before Day 4.  
c 
Pre-dose window is defined as after consent and at least 15 minutes prior to study drug administration. 
d 
Written and signed ICF/assent as applicable must be obtained before any protocol-specific assessment is performed. 
e 
Full physical examination to be performed at Screening and 24 hours post-dose.  Symptom-driven physical exams may be performed at 
other timepoints as necessary. 
f 
Both height and weight to be obtained with shoes off.   
g 
For post-menarchal females of childbearing potential only. 
h 
Blood pressure to be performed in supine position. 
i 
Blood samples for hematology and chemistry will be assessed by site’s local laboratory.  If standard of care laboratory assessments 
were performed within 24 hours prior to consent/assent, these results may be used for purposes of determining provided they meet 
protocol requirements for all screening labs. Refer to Section 8.7. 
j 
Oral study drug will be administered to subjects in the morning with no food or drink except water for at least 6 hours prior to dosing.  
After oral dosing, subjects will have no food or drink except water for at least 2 hours and no dairy products, antacids, or multivitamins 
for 4 hours.  
k 
Adverse events will be assessed from the time of signing the consent/assent until the study completion visit. 
l 
All medications taken within 72 hours prior to signing of consent/assent will be collected, in addition to all medications taken during 
the study. 
 

Omadacycline 
Paratek Pharmaceuticals, Inc. 
PTK0796-PEDPK-20110 Version 5.0 FINAL; -14-Sep-2023 
IND No. 75,928 IND No. 73,431 
Appendix 2. Sponsor Signature 
Study Title: 
Study Number: 
Final Date: 
A Phase 1, Open-Label, Multi-Center Study to Evaluate the Safety, 
Tolerability and Pharmacokinetics of Single Intravenous and Oral 
Doses of Omadacycline in Pediatric Subjects with Suspected or 
Confirmed Bacterial Infections 
PTK0796-PEDPK-20110 
14-Sep-2023 
This clinical study protocol was subject to critical review and has been approved by the 
sponsor. The following personnel contributed to writin and/or approving this protocol: 
Senior Director, Medical Affairs 
Paratek Pharmaceuticals, Inc. 
Confidential and Proprietary 
Date: 
Page 51 of52 

Omadacycline  
Paratek Pharmaceuticals, Inc. 
PTK0796-PEDPK-20110 Version 5.0 FINAL; -14-Sep-2023 
IND No. 75,928 IND No. 73,431 
 
Confidential and Proprietary 
Page 52 of 52 
Appendix 3. Investigator’s Signature  
Study Title: 
A Phase 1, Open-Label, Multi-Center Study to Evaluate the 
Safety, Tolerability and Pharmacokinetics of Single Intravenous 
and Oral Doses of Omadacycline in Pediatric Subjects with 
Suspected or Confirmed Bacterial Infections 
Study Number: 
PTK0796-PEDPK-20110 
Final Date: 
14-Sep-2023 
I have read the protocol described above.  I agree to comply with all applicable regulations 
and to conduct the study as described in the protocol.  
Signed: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date:  
 
 
 
 
 
 
Investigator Name: ___________________________________ 
Investigator Title: ____________________________________  
Investigator Affiliation: _______________________________ 
Investigator Address: _________________________________ 
Investigator Phone Number: ____________________________