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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: GFB-887

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance Clinical Research Unit Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of AEs	Safety and tolerability	Approximately 5.5 weeks
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
Plasma PK parameters: Cmax	PK	Approximately 5.5 weeks
Plasma PK parameters: Tmax	PK	Approximately 5.5 weeks
Plasma PK parameters: AUC	PK	Approximately 5.5 weeks
Urine PK parameters: Ae	PK	Approximately 5.5 weeks
Urine PK parameters: Fe	PK	Approximately 5.5 weeks
Urine PK parameters: CLR	PK	Approximately 5.5 weeks

Collaborators and Investigators

• Sponsor: Goldfinch Bio, Inc.
• Investigators: Principal Investigator: Jeanelle Kam, MD, Covance Clinical Research Unit

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 29, 2019
• Primary Completion (ACTUAL): March 4, 2020
• Study Completion (ACTUAL): April 4, 2020

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (ACTUAL): May 31, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: proteinuria; glomerulonephritis; diabetic kidney disease; Glomerulosclerosis; nephritis; diabetes complications; focal segmental glomerulosclerosis; urologic diseases; nephrotic syndrome; kidney diseases; diabetic nephropathies; endocrine system diseases; nephrosis
• Other Study ID Numbers: GFB-887-101; 8391348 (OTHER: Covance)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No