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

NCT03559166 | Completed Phase 1

• 1 other identifier: B-2660-101
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fibrosis

Outcome Measures

Primary Outcomes (5)

• Incidence of adverse events (AEs)

  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

  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

  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

  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

  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

Study Arms (11)

cohort 1a - starting dose

EXPERIMENTAL

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

Drug: BLD-2660

cohort 1b- first SAD escalation

PLACEBO COMPARATOR

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

Drug: BLD-2660

cohort 1c-2nd SAD escalation

PLACEBO COMPARATOR

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

cohort 1d-3rd SAD escalation

PLACEBO COMPARATOR

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

Drug: BLD-2660

cohort 1e-4th SAD escalation

PLACEBO COMPARATOR

Single oral dose of BLD-2660 or placebo capsule(s) administered to healthy volunteers (final dose escalation if assessed as safe).

Drug: BLD-2660

cohort 2a-1st MAD cohort

PLACEBO COMPARATOR

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

Drug: BLD-2660

cohort 2b-2nd MAD escalation

PLACEBO COMPARATOR

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

Drug: BLD-2660

cohort 2c-3rd MAD escalation

PLACEBO COMPARATOR

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

Drug: BLD-2660

cohort 2d-4th MAD escalation

PLACEBO COMPARATOR

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

Drug: BLD-2660

cohort 2e-5th MAD escalation

PLACEBO COMPARATOR

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

Drug: BLD-2660

cohort 2F-6th MAD escalation

PLACEBO COMPARATOR

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

Drug: BLD-2660

Interventions

BLD-2660 DRUG

Randomized to active product or placebo

Also known as: Placebo

cohort 1a - starting dose; cohort 1b- first SAD escalation; cohort 1c-2nd SAD escalation; cohort 1d-3rd SAD escalation; cohort 1e-4th SAD escalation; cohort 2F-6th MAD escalation; cohort 2a-1st MAD cohort; cohort 2b-2nd MAD escalation; cohort 2c-3rd MAD escalation; cohort 2d-4th MAD escalation; cohort 2e-5th MAD escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Blade Therapeutics: lead

Study Sites (1)

Nucleus Network

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ben Snyder, MD

  Nucleus Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomized, double-blind, placebo controlled
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: June 18, 2018
• Study Start: July 11, 2018
• Primary Completion: October 4, 2019
• Study Completion: October 4, 2019
• Last Updated: March 19, 2020

Record last verified: 2020-03

Locations

AU (1)