- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03559166
First in Human Study in Healthy Volunteers Followed With Dosing in Participants With Lung or Liver Fibrosis
March 17, 2020 updated by: Blade Therapeutics
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
First in Human single ascending dose followed by multiple ascending doses in healthy volunteers.
Study Overview
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3004
- Nucleus Network
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cohort 1a - starting dose
Single oral dose of BLD-2660 or placebo capsule administered to healthy volunteers
|
Randomized to active product or placebo
Other Names:
|
Placebo Comparator: cohort 1b- first SAD escalation
Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (1st dose escalation)
|
Randomized to active product or placebo
Other Names:
|
Placebo Comparator: cohort 1c-2nd SAD escalation
Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (2nd dose escalation) in fasting state, followed by washout period and then single oral dose of BLD-2660 or placebo administered to healthy volunteers in fed state.
|
Randomized to active product or placebo
Other Names:
|
Placebo Comparator: cohort 1d-3rd SAD escalation
Single oral dose of BLD-2660 or placebo capsules(s) administered to healthy volunteers (3rd dose escalation)
|
Randomized to active product or placebo
Other Names:
|
Placebo Comparator: cohort 1e-4th SAD escalation
Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (final dose escalation if assessed as safe).
|
Randomized to active product or placebo
Other Names:
|
Placebo Comparator: cohort 2a-1st MAD cohort
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers
|
Randomized to active product or placebo
Other Names:
|
Placebo Comparator: cohort 2b-2nd MAD escalation
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
|
Randomized to active product or placebo
Other Names:
|
Placebo Comparator: cohort 2c-3rd MAD escalation
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
|
Randomized to active product or placebo
Other Names:
|
Placebo Comparator: cohort 2d-4th MAD escalation
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
|
Randomized to active product or placebo
Other Names:
|
Placebo Comparator: cohort 2e-5th MAD escalation
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
|
Randomized to active product or placebo
Other Names:
|
Placebo Comparator: cohort 2F-6th MAD escalation
Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.
|
Randomized to active product or placebo
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events (AEs)
Time Frame: 2 weeks
|
AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events
|
2 weeks
|
Any observed changes in clinical safety laboratory results
Time Frame: 2 weeks
|
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
|
Any observed changes in physical examinations
Time Frame: 2 weeks
|
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
|
Any observed changes in vital signs
Time Frame: 2 weeks
|
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
|
Any observed changes in ECG
Time Frame: 2 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ben Snyder, MD, Nucleus Network
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 11, 2018
Primary Completion (Actual)
October 4, 2019
Study Completion (Actual)
October 4, 2019
Study Registration Dates
First Submitted
April 24, 2018
First Submitted That Met QC Criteria
June 5, 2018
First Posted (Actual)
June 18, 2018
Study Record Updates
Last Update Posted (Actual)
March 19, 2020
Last Update Submitted That Met QC Criteria
March 17, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-2660-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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