RecruitingPhase 1NCT07788014

A Phase 1 Study of Single and Multiple Ascending Doses of GV-100

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Asceding Doses of GV-100 With Food-Effect and Drug Drug Interaction Evaluations in Healthy Participants

Sponsor

Gilva Therapeutics Inc.

Enrollment

80 participants

Start Date

Jun 23, 2026

Study Type

INTERVENTIONAL

Conditions

ADPKD (Autosomal Dominant Polycystic Kidney Disease)

Summary

This is a first-in-human, multi-part clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), food effect, and drug-drug interaction (DDI) potential of GV-100 following oral administration in healthy participants. The study is divided into four parts: Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Food Effect (FE), and Drug-Drug Interaction (DDI).

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called GV-100 and a drug called Placebo for people with adpkd (autosomal dominant polycystic kidney disease). The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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