First in Human Study in Healthy Volunteers Followed With Dosing in Participants With Lung or Liver Fibrosis

Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03559166
• Other study ID #: B-2660-101
• Status: Completed
• Phase: Phase 1
• Start date: July 11, 2018
• Est. completion date: October 4, 2019

Study information

• Verified date: March 2020
• Source: Blade Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 4, 2019
• Est. primary completion date: October 4, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

Drug:
• BLD-2660
Randomized to active product or placebo

Locations

Country	Name	City	State
Australia	Nucleus Network	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Blade Therapeutics

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)	AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events	2 weeks
Primary	Any observed changes in clinical safety laboratory results	Assessed by reviewing any observed changes in CBC, serum chemistry or urinalysis from baseline by dose. Results in subjects dosed with BLD-2660 treatment will be compared to those dosed with placebo.	2 weeks
Primary	Any observed changes in physical examinations	Assessed by reviewing any observed changes in physical examinations from baseline by dose. Results in subjects dosed with BLD-2660 will be compared to those dosed with placebo.	2 weeks
Primary	Any observed changes in vital signs	Assessed by reviewing any observed changes in vital signs from baseline by dose. Results in subjects dosed with BLD-2660 will be compared to those dosed with placebo.	2 weeks
Primary	Any observed changes in ECG	Assessed by reviewing any observed changes in ECG from baseline by dose. Results in subjects dosed with BLD-2660 will be compared to those dosed with placebo.	2 weeks