Clinical trial NCT03970122: FIH Ph 1 Study of TRPC5 Channel Inhibitor GFB-887 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Glomerulosclerosis
proteinuria
nephrotic syndrome
nephrosis
focal segmental glomerulosclerosis
kidney diseases
urologic diseases
glomerulonephritis
nephritis
diabetic kidney disease
diabetic nephropathies
endocrine system diseases
diabetes complications
Lead sponsor: Goldfinch Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-31
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dose escalation, parallel assignment
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Incidence and severity of AEs
timeFrame: Approximately 5.5 weeks
measure: Incidence of clinically significant changes in laboratory parameters, 12 lead ECG parameters, vital signs measurements, spirometry, and physical examinations
timeFrame: Approximately 5.5 weeks
measure: Plasma PK parameters: Cmax
timeFrame: Approximately 5.5 weeks
measure: Plasma PK parameters: Tmax
timeFrame: Approximately 5.5 weeks
measure: Plasma PK parameters: AUC
timeFrame: Approximately 5.5 weeks
measure: Urine PK parameters: Ae
timeFrame: Approximately 5.5 weeks
measure: Urine PK parameters: Fe
timeFrame: Approximately 5.5 weeks
measure: Urine PK parameters: CLR
timeFrame: Approximately 5.5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Covance Clinical Research Unit Inc.
state: Texas
Study officials:
affiliation: Covance Clinical Research Unit
name: Jeanelle Kam, MD
role: PRINCIPAL_INVESTIGATOR
References: