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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03970122
• Other study ID #: GFB-887-101
• Secondary ID: 8391348
• Status: Completed
• Phase: Phase 1
• Start date: May 29, 2019
• Est. completion date: April 4, 2020

Study information

• Verified date: June 2020
• Source: Goldfinch Bio, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 4, 2020
• Est. primary completion date: March 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Healthy Participant Cohorts - Key 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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• GFB-887
IMP
• Placebo
Matching

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit Inc.	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Goldfinch Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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