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

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ClinicalTrials.gov Identifier: NCT03559166
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Blade Therapeutics

Brief Summary:
First in Human single ascending dose followed by multiple ascending doses in healthy volunteers followed by multi dose in participants with lung or liver fibrosis.

Condition or disease Intervention/treatment Phase
Fibrosis Drug: BLD-2660 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: cohort 1 a-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 Name: 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 Name: 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 Name: 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 Name: Placebo

Placebo Comparator: cohort 1e (optional cohort)
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 Name: Placebo

Placebo Comparator: cohort 2 a-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 Name: 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 Name: 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 Name: Placebo

Placebo Comparator: cohort 3a
Therapeutic oral dose (as determined by SAD and MAD data) of BLD-2660 or placebo capsule(s) administered to participants with lung fibrosis
Drug: BLD-2660
Randomized to active product or placebo
Other Name: Placebo

Placebo Comparator: cohort 3 b
Therapeutic oral dose (as determined by SAD and MAD data) of BLD-2660 or placebo capsule(s) administered to participants with liver fibrosis
Drug: BLD-2660
Randomized to active product or placebo
Other Name: Placebo




Primary Outcome Measures :
  1. 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. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03559166


Contacts
Contact: Nancy Havrilla, MS, RN 530.417.0496 nhavrilla@blademed.com
Contact: Shaily Jaini Garg 650.521.4496 sgarg@blademed.com

Locations
Australia, Victoria
Nucleus Network Recruiting
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Blade Therapeutics
Investigators
Principal Investigator: Ben Snyder, MD Nucleus Network

Responsible Party: Blade Therapeutics
ClinicalTrials.gov Identifier: NCT03559166     History of Changes
Other Study ID Numbers: B-2660-101
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases