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

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

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

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: GFB-887
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Healthy Participant Cohorts - Key Inclusion Criteria: Males or females, of any race, between 18 and 55 years of age, inclusive, at Screening. Body mass index between 18.0 and 32.0 kg/m^2, inclusive, at Screening. 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. Female participants will be post-menopausal or surgically sterile (as confirmed by medical history). Male participants will agree to use contraception while on study drug and for at least 90 days after the final follow-up visit. Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions. Participants must be in good health. Healthy Participant Cohorts - Key Exclusion Criteria: Females of childbearing potential. 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). History of alcoholism or drug/chemical abuse within 2 years prior to (first) Check-in. Use of tobacco or nicotine-containing products within 60 days prior to (first) dosing, or positive cotinine at Screening or Check-in.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Dose escalation, parallel assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GFB-887 SAD active<br>GFB-887 single dose active | Drug: GFB-887<br>* IMP<br>|
| Placebo Comparator: GFB-887 SAD placebo<br>GFB-887 single dose placebo | Drug: Placebo<br>* Matching<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glomerulosclerosis, proteinuria, nephrotic syndrome, nephrosis, focal segmental glomerulosclerosis, kidney diseases, urologic diseases, glomerulonephritis, nephritis, diabetic kidney disease, diabetic nephropathies, endocrine system diseases, diabetes complications