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

NCT07788014 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-08-26

No results posted yet for this study

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).

Conditions

  • ADPKD (Autosomal Dominant Polycystic Kidney Disease)

Interventions

DRUG

GV-100

GV-100 will be administered orally

DRUG

Placebo

Matched to GV-100

Sponsors & Collaborators

  • Gilva Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-23
Primary Completion
2027-03-31
Completion
2027-03-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07788014 on ClinicalTrials.gov