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

Sponsor
Blade Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT03559166
Collaborator
(none)
88
Enrollment
1
Location
11
Arms
14.8
Actual Duration (Months)
6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Randomized, double-blind, placebo controlled
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 11, 2018
Actual Primary Completion Date :
Oct 4, 2019
Actual Study Completion Date :
Oct 4, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: cohort 1a - starting dose

Single oral dose of BLD-2660 or placebo capsule administered to healthy volunteers

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

    		•
    Placebo Comparator: cohort 1b- first SAD escalation

    Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (1st dose escalation)

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

    		•
    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.

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

    		•
    Placebo Comparator: cohort 1d-3rd SAD escalation

    Single oral dose of BLD-2660 or placebo capsules(s) administered to healthy volunteers (3rd dose escalation)

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

    		•
    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).

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

    		•
    Placebo Comparator: cohort 2a-1st MAD cohort

    Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers

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

    		•
    Placebo Comparator: cohort 2b-2nd MAD escalation

    Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.

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

    		•
    Placebo Comparator: cohort 2c-3rd MAD escalation

    Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.

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

    		•
    Placebo Comparator: cohort 2d-4th MAD escalation

    Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.

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

    		•
    Placebo Comparator: cohort 2e-5th MAD escalation

    Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.

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

    		•
    Placebo Comparator: cohort 2F-6th MAD escalation

    Multiple oral doses of BLD-2660 or placebo capsule(s) administered to healthy volunteers.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events (AEs) [2 weeks]

      AEs will be assessed by determining the incidence, severity, and dose relationship of adverse events

    2. Any observed changes in clinical safety laboratory results [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.

    3. Any observed changes in physical examinations [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.

    4. Any observed changes in vital signs [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.

    5. Any observed changes in ECG [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nucleus Network Melbourne Victoria Australia 3004

    Sponsors and Collaborators

    • Blade Therapeutics

    Investigators

    • Principal Investigator: Ben Snyder, MD, Nucleus Network

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Blade Therapeutics
    ClinicalTrials.gov Identifier:
    NCT03559166
    Other Study ID Numbers:
    • B-2660-101
    First Posted:
    Jun 18, 2018
    Last Update Posted:
    Mar 19, 2020
    Last Verified:
    Mar 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Liver Cirrhosis
    Fibrosis

    Study Results

    No Results Posted as of Mar 19, 2020