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

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).

Study Overview

• Status: Recruiting
• Conditions: ADPKD (Autosomal Dominant Polycystic Kidney Disease)
• Intervention / Treatment: Drug: GV-100; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: I-Chu Tsai; Phone Number: +886-2-33661914; Email: ichu@gilvatherap.com

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • CMAX Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Male or female participants, aged more than or equal 18 to less than or equal to 65 years at the time of providing informed consent, who are non-smokers (no use of tobacco or nicotine-containing products within 3 months prior to screening), with a body mass index (BMI) greater than 18.0 and less than 32.0 kilogram/meter square, and a minimum body weight of 50.0 kilogram.

• Healthy individuals, as determined by the Principal Investigator or delegate, defined as:

  1. No clinically significant illness or surgical procedures within 4 weeks prior to study drug administration.
  2. No clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, or metabolic disorders.
• Capable of understanding the study procedures and willing to provide written informed consent prior to participation.

Exclusion Criteria:

• Any clinically significant abnormal finding on physical examination, as determined by the Principal Investigator or delegate.
• Clinically significant abnormal laboratory results at screening, in the opinion of the Principal Investigator or delegate.
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and/or total bilirubin levels greater than 1.5 × the upper limit of normal (ULN) at screening.
• Estimated glomerular filtration rate (eGFR) Less than or equal 90 milliliter/minute/1.73 meter square at screening, calculated using the CKD-EPI equation.
• Positive test results at screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen or antibody.

Participants with a positive hepatitis B surface antibody (HBsAb) due to prior vaccination are permitted.

• Any current active infection, including localized infections, or a recent history (within 1 week prior to dosing) of infection, cough, or fever, or a history of recurrent or chronic infections.
• Any disease or history of surgery that, in the opinion of the Principal Investigator or delegate, could significantly affect the absorption, distribution, metabolism, or excretion of the investigational product.
• Positive pregnancy test or lactation in female participants.
• Positive urine drug screen, urine cotinine test, or alcohol breath test.
• History of clinically significant allergic reactions, including anaphylaxis, hypersensitivity, or angioedema, to any medication, or known allergy to GV-100, related compounds, or any formulation excipients.
• Clinically significant abnormalities in ECG findings or vital signs at screening, as determined by the Principal Investigator or delegate.
• Supine systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 95 millimeters of mercury. (mmHg) at screening after at least 5 minutes of rest. If elevated, blood pressure will be repeated two additional times, and the average of three measurements will be used to assess eligibility.
• History of drug abuse within 6 months prior to first dosing, or substance abuse considered clinically significant by the Principal Investigator or delegate.

• History of alcohol abuse within 6 months prior to first dosing, defined as consumption exceeding 21 units per week for males or 14 units per week for females

  (1 unit = 240 milliliter beer, 120 milliliter wine, or 30 milliliter distilled Alcohol).

• Use of depot injections or implants within 3 months prior to first dosing.
• Receipt of live or live-attenuated vaccines (bacterial or viral) within 12 weeks prior to screening, or planned receipt during the study period.
• Receipt of any vaccine, including COVID-19 vaccines, within 14 days prior to first dosing.
• Use of any drug known to induce or inhibit hepatic drug-metabolizing enzymes within 30 days or 5 half- lives (whichever is longer) prior to first dosing.
• Use of prescription medications within 14 days or 5 half-lives (whichever is longer) prior to first dosing.
• Use of over-the-counter medications or natural health products, including herbal remedies (e.g., St.

John's wort), traditional medicines, probiotics, dietary supplements, or sports supplements within 14 days or 5 half-lives (whichever is longer) prior to first dosing, except for occasional paracetamol up to 2 grams/day.

• Participation in another clinical research study involving an investigational or marketed drug or device within 30 days or 5 half-lives (whichever is longer) prior to first dosing; participation involving a biological product within 90 days prior to dosing; or concurrent participation in any investigational study without drug or device administration.
• Donation of plasma or platelets within 14 days prior to dosing, or donation or loss of equals 500 milliliter of whole blood within 60 days prior to dosing.
• Previous exposure to GV-100.
• Any other condition or circumstance that, in the opinion of the Principal Investigator or delegate, could interfere with study participation or compliance, which will be documented in the source records.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matched to GV-100
Experimental: GV-100	Drug: GV-100; GV-100 will be administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse event	Up to 7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum plasma concentration (Cmax) of GV-100	Plasma concentration of GV-100	Part 1: From Day 1 to Day 2 Part 2: From Day 1 to Day 15 Part 3: From Day 1 to Day 9 Part 4: From Day 1 to Day 15
Area under the plasma concentration time curve (AUC) of GV-100	Measure of AUC	Part 1: From Day 1 to Day 2 Part 2: From Day 1 to Day 15 Part 3: From Day 1 to Day 9 Part 4: From Day 1 to Day 15

Collaborators and Investigators

• Sponsor: Gilva Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: August 20, 2026
• First Submitted That Met QC Criteria: August 23, 2026
• First Posted (Actual): August 26, 2026

Study Record Updates

• Last Update Posted (Actual): August 26, 2026
• Last Update Submitted That Met QC Criteria: August 23, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: GV-100
• Additional Relevant MeSH Terms: Ciliopathies; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genetic Diseases, Inborn; Congenital Abnormalities; Abnormalities, Multiple; Kidney Diseases, Cystic; Polycystic Kidney Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Polycystic Kidney, Autosomal Dominant
• Other Study ID Numbers: GV-GV100-CT01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: May not be published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No