FIH Ph 1 Study of TRPC5 Channel Inhibitor GFB-887 in Healthy Subjects

Sponsor

Goldfinch Bio, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03970122

Collaborator

(none)

Enrollment

Location

Arms

10.2

Actual Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will comprise primarily a single-ascending dose (SAD) escalation component.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: GFB-887 Drug: Placebo	Phase 1

Detailed Description

Double-blind, randomized, placebo-controlled, single-dose, sequential-group design in up to 7 cohorts of healthy participants.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Dose escalation, parallel assignmentDose escalation, parallel assignment

Masking:

Double (Participant, Investigator)

Masking Description:

Blinded

Primary Purpose:

Other

Official Title:

A First-In-Human, Phase 1, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GFB-887, a TRPC5 Channel Inhibitor, in Healthy Subjects

Actual Study Start Date :

May 29, 2019

Actual Primary Completion Date :

Mar 4, 2020

Actual Study Completion Date :

Apr 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GFB-887 SAD active GFB-887 single dose active	Drug: GFB-887 IMP
Placebo Comparator: GFB-887 SAD placebo GFB-887 single dose placebo	Drug: Placebo Matching

Arm

Intervention/Treatment

Experimental: GFB-887 SAD active

GFB-887 single dose active

Drug: GFB-887

IMP

Placebo Comparator: GFB-887 SAD placebo

GFB-887 single dose placebo

Drug: Placebo

Matching

Outcome Measures

Primary Outcome Measures

Incidence and severity of AEs [Approximately 5.5 weeks]
Safety and tolerability
Incidence of clinically significant changes in laboratory parameters, 12 lead ECG parameters, vital signs measurements, spirometry, and physical examinations [Approximately 5.5 weeks]
Safety and tolerability
Plasma PK parameters: Cmax [Approximately 5.5 weeks]
PK
Plasma PK parameters: Tmax [Approximately 5.5 weeks]
PK
Plasma PK parameters: AUC [Approximately 5.5 weeks]
PK
Urine PK parameters: Ae [Approximately 5.5 weeks]
PK
Urine PK parameters: Fe [Approximately 5.5 weeks]
PK
Urine PK parameters: CLR [Approximately 5.5 weeks]
PK

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Healthy Participant Cohorts - Key Inclusion Criteria:

Males or females, of any race, between 18 and 55 years of age, inclusive, at Screening.
Body mass index between 18.0 and 32.0 kg/m^2, inclusive, at Screening.
Systolic blood pressure of between 90 and 140 mmHg, diastolic blood pressure between 60 and 90 mmHg, and heart rate between 40 and 100 bpm at Screening.
Female participants will be post-menopausal or surgically sterile (as confirmed by medical history).
Male participants will agree to use contraception while on study drug and for at least 90 days after the final follow-up visit.
Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
Participants must be in good health.

Healthy Participant Cohorts - Key Exclusion Criteria:

Females of childbearing potential.
Significant history or clinically significant manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
History of alcoholism or drug/chemical abuse within 2 years prior to (first) Check-in.
Use of tobacco or nicotine-containing products within 60 days prior to (first) dosing, or positive cotinine at Screening or Check-in.