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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001130358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
28/07/2026
Date registered
Help: Date registered
10/09/2026
Date last updated
Help: Date last updated
10/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
10/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of GV-100 (Part3)
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of Single
and Multiple Ascending Doses of GV-100 with Food-Effect and Drug-Drug
Interaction Evaluations in Healthy Participants ((Part 3)
Additional trial identifiers [1] 317605 0
GV-GV100-CT01
Universal Trial Number (UTN)
Trial acronym
Related trial records
ACTRN12626000762358 describes part 1 and 2 of this 4-part study and this is part 3.

Health condition
Health condition(s) studied:
Autosomal Dominant Polycystic Kidney Disease (ADPKD) 342383 0
Condition category
Condition code
Renal and Urogenital 338509 338509 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Part 3: Food Effect (FE)

Participants will be administered one selected dose of GV-100 on Day 1 (treatment period 1) and on Day 8 (treatment period 2) under fasted and fed conditions in a 2-way crossover, according to one of the treatment sequences. The planned dose of GV-100 for part 3 FE is 400 mg (the final dose will be selected based on the data from the preceding cohorts).

The Food Effect part will assess the effect of food on the Pharmacokinetic (PK) of GV-100 and may be initiated after Safety Review Committee (SRC) approval of safety and Pharmacokinetic (PK) data from a single ascending dose (SAD) dose level higher than the planned Food Effect dose. The planned dose is 400 milligrams, with the final dose selected based on emerging single ascending dose (SAD) data and below the highest acceptable Single Ascending Dose (SAD).

Approximately 12 participants will be enrolled in a randomized, 2-way crossover design, receiving GV-100 under fasted and fed conditions in alternate periods. Participants will be screened between Day -28 and Day -2. For Treatment Period 1, participants will be admitted on Day -1, dosed on Day 1, and confined through Day 2. After a minimum 7-day washout, Treatment Period 2 will follow with dosing on Day 8 and confinement through Day 9. A follow-up visit will occur on Day 15 (±1 day).

A mouth check will be performed following administration to confirm complete consumption of the IP while inpatient admission.

Fastened Condition (Control): 10hours of fasting before Dosing until after dosing 4hours. No fluids will be allowed from 1 hour before dosing until 1 hour after dosing. Water will be permitted ad libitum at all other times.

Fed Condition: Supervised Fast of 10hours, High fat high calorie meal will be served with 800-1000 Calories (approximately 50% of total caloric content of the meal derived from fat) of food which will be derived with 150, 250 & 500-600 Calories from Protein, Carbohydrate and fat respectively. No Fluids allowed before and after 1 Hour of Dosing.
Intervention code [1] 334429 0
Treatment: Drugs
Description of the comparator or control
Crossover design (Fed & Fastened Condition)
Control group
Active

Outcomes
Primary outcome [1] 345796 0
Part 3: Safety and tolerability will be assessed as a composite outcome, including adverse events (AEs), vital signs, 12-lead ECGs, and safety laboratory tests for Fed and Fasting condition
Timepoint [1] 345796 0
Part 3: Food Effect Vital Signs: At screening, on Day -1, on Day 1 prior to dosing, on Day 7, on Day 8 prior to dosing, and at follow-up (or ET(Day15)). Safety Laboratory Test: At screening, on Day -1, at 24 hours post-Day 1-dose (Day 2), on Day 7, at 24 hours post-Day 8-dose (Day 9), and at follow-up (or ET(Day15)). 12Lead ECG: At screening, on Day -1, on Day 1 prior to dosing and at 4, 12, and 24 (Day 2) hours post-dose, on Day 7, on Day8 prior to dosing and at 4, 12, and 24 (Day 9) hours post-dose, and at follow-up (or ET (Day15)). Adverse Events: From screening to FU/EOS/ET(Day15) .
Secondary outcome [1] 463325 0
Part3: PK parameters derived from plasma GV-100 concentration following single oral dose in fed and fasted states.
Timepoint [1] 463325 0
A total of 18 blood samples will be collected for PK analysis: on Day 1 at 30 mins prior to dosing and 0.5, 1, 2, 4, 6, 8, 12, and 24 (Day 2) hours post-dose; on Day 8 at 30 mins prior to dosing and 0.5, 1, 2, 4, 6, 8, 12, and 24 (Day 9) hours post-dose

Eligibility
Key inclusion criteria
- Male or female participants, aged more than or equal 18 to less than or equal to 65 years at the time ofproviding informed consent, who are non-smokers (no use of tobacco or nicotine-containing productswithin 3 months prior to screening), with a body mass index (BMI) greater than 18.0 and less than 32.0kilogram/meter square, and a minimum body weight of 50.0 kilogram.
- Healthy individuals, as determined by the Principal Investigator or delegate, defined as:
a. No clinically significant illness or surgical procedures within 4 weeks prior to study drug administration.
b. 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 toparticipation.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
Yes
Key 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 and 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 Chronic Kidney Disease Epidemiology Collaboration (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 Electrocardiogram (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 equals 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 2grams/day.
- Participation in another clinical research study involving an investigational or marketed drug or devicewithin 30 days or 5 half-lives (whichever is longer) prior to first dosing; participation involving a biologicalproduct within 90 days prior to dosing; or concurrent participation in any investigational study without drugor device administration.
- Donation of plasma or platelets within 14 days prior to dosing, or donation or loss of equals 500 milliliterof 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.
- Participants unable to complete the required high-fat meal within the specified timeframe and those who follow a strict vegetarian or vegan diet will be excluded from participation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The Master Randomization List was generated via central and fixed blocked randomization method.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The pharmacist will assign randomization numbers consecutively according to the sequence being dosed in accordance with the Master Randomization List.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/10/2026
Actual
Date of last participant enrolment
Anticipated
3/11/2026
Actual
Date of last data collection
Anticipated
17/11/2026
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 322159 0
Commercial sector/Industry
Name [1] 322159 0
Gilva Therapeutics, INC.
Country [1] 322159 0
Taiwan, Province Of China
Primary sponsor type
Commercial sector/Industry
Name
Gilva Therapeutics, INC.
Address
Country
Taiwan, Province Of China
Secondary sponsor category [1] 325056 0
Commercial sector/Industry
Name [1] 325056 0
Novotech (Australia) Pty Limited
Address [1] 325056 0
Country [1] 325056 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320691 0
Bellberry Human Research Ethics Committee D
Ethics committee address [1] 320691 0
Ethics committee country [1] 320691 0
Australia
Date submitted for ethics approval [1] 320691 0
25/03/2026
Approval date [1] 320691 0
01/05/2026
Ethics approval number [1] 320691 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 151294 0
Dr Jonathan Newchurch
Address 151294 0
CMAX Clinical Research, 21-24 North Terrace, Adelaide, SA 5000, Australia
Country 151294 0
Australia
Phone 151294 0
+61423223756
Fax 151294 0
Email 151294 0
[email protected]
Contact person for public queries
Name 151295 0
Jonathan Newchurch
Address 151295 0
CMAX Clinical Research, 21-24 North Terrace, Adelaide, SA 5000, Australia
Country 151295 0
Australia
Phone 151295 0
+61423223756
Fax 151295 0
Email 151295 0
[email protected]
Contact person for scientific queries
Name 151296 0
Jonathan Newchurch
Address 151296 0
CMAX Clinical Research, 21-24 North Terrace, Adelaide, SA 5000, Australia
Country 151296 0
Australia
Phone 151296 0
+61423223756
Fax 151296 0
Email 151296 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.