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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Placebo; Drug: GFB-887

• Registration Number: NCT03970122
• Lead Sponsor: Goldfinch Bio, Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2019-05-24
• Study Start: 2019-05-29
• Study First Submitted QC: 2019-05-29
• Study First Posted: 2019-05-31
• Primary Completion: 2020-03-04
• Study Completion: 2020-04-04
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-01
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Males or females, of any race, between 18 and 55 years of age, inclusive, at Screening.
2. Body mass index between 18.0 and 32.0 kg/m^2, inclusive, at Screening.
3. 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.
4. Female participants will be post-menopausal or surgically sterile (as confirmed by medical history).
5. Male participants will agree to use contraception while on study drug and for at least 90 days after the final follow-up visit.
6. Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
7. Participants must be in good health.

Healthy Participant Cohorts - Key

Exclusion Criteria

1. Females of childbearing potential.
2. 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).
3. History of alcoholism or drug/chemical abuse within 2 years prior to (first) Check-in.
4. Use of tobacco or nicotine-containing products within 60 days prior to (first) dosing, or positive cotinine at Screening or Check-in.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GFB-887 SAD placebo	Placebo	GFB-887 single dose placebo
GFB-887 SAD active	GFB-887	GFB-887 single dose active

Primary Outcome Measures

Name	Time	Method
Urine PK parameters: CLR	Approximately 5.5 weeks	PK
Plasma PK parameters: Tmax	Approximately 5.5 weeks	PK
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: AUC	Approximately 5.5 weeks	PK
Urine PK parameters: Ae	Approximately 5.5 weeks	PK
Urine PK parameters: Fe	Approximately 5.5 weeks	PK

Trial Locations

Locations (1)

Covance Clinical Research Unit Inc.; 🇺🇸 Dallas, Texas, United States