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

Goldfinch Bio

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: GFB-887; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03970122

8391348 (Other Identifier)

GFB-887-101

Details and patient eligibility

About

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

Full description

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

Enrollment: 70 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

70 participants in 2 patient groups, including a placebo group

GFB-887 SAD active

Experimental group

Description:

GFB-887 single dose active

Treatment:

Drug: GFB-887

GFB-887 SAD placebo

Placebo Comparator group

Description:

GFB-887 single dose placebo

Treatment:

Drug: Placebo