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

NCT ID: NCT03559166

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-11
• Study Completion Date: 2019-10-04

Brief Summary

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

Conditions

Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

cohort 1a - starting dose

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

Group Type: EXPERIMENTAL

BLD-2660

Intervention Type: DRUG

Randomized to active product or placebo

cohort 1b- first SAD escalation

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

Group Type: PLACEBO_COMPARATOR

BLD-2660

Intervention Type: DRUG

Randomized to active product or placebo

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.

Group Type: PLACEBO_COMPARATOR

BLD-2660

Intervention Type: DRUG

Randomized to active product or placebo

cohort 1d-3rd SAD escalation

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

Group Type: PLACEBO_COMPARATOR

BLD-2660

Intervention Type: DRUG

Randomized to active product or placebo

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).

Group Type: PLACEBO_COMPARATOR

BLD-2660

Intervention Type: DRUG

Randomized to active product or placebo

cohort 2a-1st MAD cohort

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

Group Type: PLACEBO_COMPARATOR

BLD-2660

Intervention Type: DRUG

Randomized to active product or placebo

cohort 2b-2nd MAD escalation

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

Group Type: PLACEBO_COMPARATOR

BLD-2660

Intervention Type: DRUG

Randomized to active product or placebo

cohort 2c-3rd MAD escalation

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

Group Type: PLACEBO_COMPARATOR

BLD-2660

Intervention Type: DRUG

Randomized to active product or placebo

cohort 2d-4th MAD escalation

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

Group Type: PLACEBO_COMPARATOR

BLD-2660

Intervention Type: DRUG

Randomized to active product or placebo

cohort 2e-5th MAD escalation

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

Group Type: PLACEBO_COMPARATOR

BLD-2660

Intervention Type: DRUG

Randomized to active product or placebo

cohort 2F-6th MAD escalation

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

Group Type: PLACEBO_COMPARATOR

BLD-2660

Intervention Type: DRUG

Randomized to active product or placebo

Interventions

BLD-2660

Randomized to active product or placebo

Intervention Type: DRUG

Other Intervention Names

Placebo

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Blade Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ben Snyder, MD

Role: PRINCIPAL_INVESTIGATOR

Nucleus Network

Locations

Nucleus Network

Melbourne, Victoria, Australia

Countries

Australia

Other Identifiers

B-2660-101

Identifier Type: -

Identifier Source: org_study_id