Clinical trial NCT03559166: First in Human Study in Healthy Volunteers Followed With Dosing in Participants With Lung or Liver Fibrosis
Official title: A Phase Ia/Ib, Randomized, Double Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BLD-2660 in Healthy Volunteers and Patients With Lung Fibrosis or Liver Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fibrosis
Lead sponsor: Blade Therapeutics
Sponsor class: INDUSTRY
First posted: 2018-06-18
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: First in Human single ascending dose followed by multiple ascending doses in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Able to provide written informed consent
* Agree to no smoking or alcohol or illegal substance 48 hours prior to dosing
* Have a negative urine drug screen/alcohol breath test on admission to clinic
* Agree to use highly effective, double barrier contraception (both male and female partners) during the study and for 30 days following completion of dosing
* Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1
* Normal BMI except liver fibrosis participants (BMI 18 to ≤35 kg/m2)
* Be in general good health
* Clinical laboratory values within normal range
* Lung fibrosis participants-a diagnosis of lung fibrosis,
* Liver fibrosis participants-a diagnosis of liver fibrosis; some abnormal laboratory values will be acceptable for the following; platelet count, albumin, serum creatinine and neutrophil-leukocyte ration

Exclusion Criteria:

* Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the subject will complete the study per protocol
* History or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration, and unwillingness to be totally abstinent during the dosing period
* Blood donation or significant blood loss within 60 days prior to the first study drug administration
* Plasma donation within 7 days prior to the first study drug administration
* Administration of investigational product (IP) in another trial within 30 days prior to the first study drug administration, or five half-lives, whichever is longer
* Females who are pregnant or lactating
* Surgery within the past 3 months prior to the first study drug administration determined by the PI to be clinically relevant
* Failure to satisfy the PI of fitness to participate for any other reason
* Active infection or history of recurrent infections
* Active malignancy and history of malignancy in the past 5 years, with the exception of completely excised basal cell carcinoma or low grade cervical intraepithelial neoplasia
* Chronic obstructive pulmonary disease
* Antibiotic treatment within 3 months
* Chronic medical condition

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: 2 weeks
measure: Any observed changes in clinical safety laboratory results
timeFrame: 2 weeks
measure: Any observed changes in physical examinations
timeFrame: 2 weeks
measure: Any observed changes in vital signs
timeFrame: 2 weeks
measure: Any observed changes in ECG
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network
state: Victoria
Study officials:
affiliation: Nucleus Network
name: Ben Snyder, MD
role: PRINCIPAL_INVESTIGATOR
References: