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

NCT07788014 | Recruiting Phase 1

• 1 other identifier: GV-GV100-CT01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

GV-100

Outcome Measures

Primary Outcomes (1)

• Adverse event

  Up to 7 weeks

Secondary Outcomes (2)

• Maximum plasma concentration (Cmax) 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

  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

Study Arms (2)

GV-100

EXPERIMENTAL

Drug: GV-100

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

GV-100 DRUG

GV-100 will be administered orally

GV-100

Placebo DRUG

Matched to GV-100

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• No clinically significant illness or surgical procedures within 4 weeks prior to study drug administration.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilva Therapeutics Inc.: lead

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

RECRUITING

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Central Study Contacts

I-Chu Tsai

CONTACT

+886-2-33661914; ichu@gilvatherap.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 26, 2026
• Study Start: June 23, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

AU (1)