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NCT07788014 · ClinicalTrials.gov record · last posted 2026-08-26

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

Name: A Phase 1 Study of Single and Multiple Ascending Doses of GV-100 — clinical trial record (NCT07788014)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

StatusRecruiting

PhasePhase 1

SponsorGilva Therapeutics Inc.

Started2026-06-23

View on ClinicalTrials.gov ↗

from the ClinicalTrials.gov record

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).

Trial Details

NCT Number	NCT07788014
Lead Sponsor	Gilva Therapeutics Inc.
Conditions	ADPKD (Autosomal Dominant Polycystic Kidney Disease)
Enrollment	80 participants
Start Date	2026-06-23
Primary Completion	2027-03-31 (estimated)
Study Completion	2027-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-08-26