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

Blade Therapeutics

Status and phase

Completed

Phase 1

Conditions

Fibrosis

Treatments

Drug: BLD-2660

Study type

Interventional

Funder types

Industry

Identifiers

NCT03559166

B-2660-101

Details and patient eligibility

About

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

Enrollment

88 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

88 participants in 11 patient groups, including a placebo group

cohort 1a - starting dose

Experimental group

Description:

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

Treatment:

Drug: BLD-2660

cohort 1b- first SAD escalation

Placebo Comparator group

Description:

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

Treatment:

Drug: BLD-2660

cohort 1c-2nd SAD escalation

Placebo Comparator group

Description:

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.

Treatment:

Drug: BLD-2660

cohort 1d-3rd SAD escalation

Placebo Comparator group

Description:

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

Treatment:

Drug: BLD-2660

cohort 1e-4th SAD escalation

Placebo Comparator group

Description:

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

Treatment:

Drug: BLD-2660

cohort 2a-1st MAD cohort

Placebo Comparator group

Description:

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

Treatment:

Drug: BLD-2660

cohort 2b-2nd MAD escalation

Placebo Comparator group

Description: