Healthy VolunteersPhase 1NCT06081465
A Phase I Study of Single and Multiple Doses of VG290131 in Healthy Subjects
A Phase 1 study testing VG290131 in people with Healthy Volunteers, run by Zhejiang Vimgreen Pharmaceuticals, Ltd. at 1 site in Australia.
Trial summary
This is a randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability and PK profiles of orally administered VG290131 in healthy subjects. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- VG290131
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Oct 2023to Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A subject will be eligible for inclusion in this study only if all of the following criteria are met:
- Willing to comply with protocol required visit schedule and visit requirements and provide written ICF;
- Healthy adult male and female subjects, aged 18 to 45 years of age (inclusive) at the time of signing the ICF;
- Body mass index between 18.0 and 32.0 kg/m2, inclusive;
- Considered medically healthy as determined by the investigator, based on medical history and clinical evaluations including physical examination, clinical laboratory tests, vital sign measurements, and 12-Lead ECG;
- Male subjects must agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior to screening and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom plus effective contraception methods for their female partner, if of childbearing potential, from the signing of ICF to 3 months after the last dose of IMPs and refrain from donating sperm during this period. These contraception requirements do not apply if the male subject is in an exclusively same sex relationship;
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- Female subjects are eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
- Women of non-childbearing potential (WONCBP), defined as surgically sterile (hysterectomy, bilateral salpingectomy, bilateral tubal ligation or bilateral oophorectomy - verbal confirmation through medical history review acceptable) or postmenopausal (no menses for 12 months and confirmed by follicle stimulating hormone [FSH] level ≥40 mlU/mL);
- WOCBP and agree to practice true abstinence or agrees to use a highly effective method of contraceptions consistently from the signing of ICF to 3 months after the last dose of investigational medicinal products [IMPs] and refrain from donating eggs during this period. And WOCBP must have a negative serum and/or urine pregnancy test result within 7 days prior to the first dose of IMPs.
- Subject is in an exclusively same-sex relationship.
Who cannot join
- A subject meeting any of the following exclusion criteria will not be allowed to participate in this study:
- Ascertained or presumptive hypersensitivity (including allergies) to any ingredient of the VG290131; history of other significant allergies or anaphylaxis, as determined by the investigator;
- Considered by the investigator to be ineligible for the study due to a history of or current condition of significant metabolic or endocrine, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, immunological, neurological, or psychiatric disorders with clinical manifestations;
- Active or history of serious mental illness or psychiatric disorder, including but not limited to schizophrenia, bipolar disorder, or severe depression, which require current pharmacological intervention;
- History of stomach or intestinal surgery or resection diseases including but not limited to, gastric band/gastric resection and/or intestinal resection and/or duodenal disease (i.e. celiac disease) which may potentially alter absorption and/or excretion of VG290131 (except for an appendectomy);
- Used drugs or substances known to be inducers or inhibitors of cytochrome P450 enzymes or P-glycoprotein (P-gp) substrates within 28 days or 5 half-lives (whichever is longer) prior to the first dose of IMPs;
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- Used prescription or over-the-counter (OTC) drugs (with the exception of hormonal contraception, menopausal hormone replacement therapy or occasional analgesics such as Paracetamol [1 g per dose and maximum 2-4 g per day], Ibuprofen and standard daily vitamins etc. in short term at the Investigator's discretion), within 14 days or 5 half-lives (whichever is longer) prior to the first dose of IMPs;
- Participated in any other investigational trials or has been exposed to other investigational drugs within 28 days or 5 half-lives of the previously administered investigational drug, whichever is longer, prior to the first dose of IMPs;
- Smoking ≥ 5 cigarettes per day (or an equivalent amount of any other nicotine-containing products) within 6 months before screening or unable to stop smoking during the study;
- Alcohol consumption of > 21 units per week for males and > 14 units per week for females within the 6 months before screening (1 unit=360 mL of beer or 45 mL of spirits with an alcohol content of ≥ 40% or 150 mL of wine) or a positive result of alcohol breath test on admission or unable to abstain from consuming alcohol from 24 h prior to admission, until completion of the end of study (EOS) visit;
- History of drug abuse within the 12 months before screening or a positive result of drug abuse test at screening;
- Consumption of any nutrients known to modulate cytochrome P450 enzymes or P-gp substrates activity (eg, grapefruit, pomelo, mango, star fruit, Seville [blood] orange products, caffeine or xanthine-containing food or beverages) within 72 h before the first dose of IMPs;
- Clinically significant laboratory abnormalities, as determined by the Investigator, including but not limited to (If the results are beyond the normal range or significantly changed, the investigator deems it necessary to repeat the measurement, vital signs and 12-Lead ECG may be repeated twice, clinical laboratory tests [hematology, urinalysis, biochemistry and coagulation function test] may be repeated once):
- Systolic blood pressure (SBP) ≥ 140 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg after 5 minutes of supine rest;
- Supine resting bradycardia (pulse heart rate [HR] <40 bpm) or a supine resting tachycardia (HR >100 bpm);
- A corrected QT (QTc) interval of > 450 ms for males and > 470 ms for females (Fridericia's method);
- Liver function: aspartate aminotransferase [AST], alanine transaminase [ALT], alkaline phosphatase [ALP], γ-glutamyl transferase [γ- GGT]) or total bilirubin (TBIL) >1.5 × upper limit of normal (ULN);
- Renal function: creatinine clearance rate ≤80 mL/min (calculated based on Cockcroft-Gault formula);
- Other laboratory parameters demonstrating clinically significant abnormalities, as determined by the investigator;
- Known active infections, e.g., bacterial, fungal and viral infections, including:
- Human immunodeficiency virus (HIV) infection: defined as HIV antibody positive;
- Syphilis infection: defined as treponema pallidum antibody (TP-Ab) positive;
- Active hepatitis B virus (HBV): defined as hepatitis B surface antigen (HBsAg) positive, Hepatitis B core antibody (HBcAb) positive and hepatitis B virus (HBV)-deoxyribonucleic acid (DNA) ≥ lab-specific ULN (for those with positive result on HBcAb or HBsAg, HBV DNA test will be performed and those with positive HBV DNA results will be excluded);
- Active hepatitis C virus (HCV): defined as HCV antibody (HCV-Ab) positive and HCV-ribonucleic acid (RNA) positive, if HCV-Ab positive and HCV RNA negative can be considered as eligible at the discretion of the Investigator;
- Has donated blood or plasma within 30 days prior to screening or had a loss of whole blood of more than 500 mL within the 30 days prior to screening, or receipt of a blood transfusion within one year prior to screening;
- The subject has difficulty in swallowing oral medications;
- Inability to be venipunctured and/or tolerate venous access; Any conditions which would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Linear Clinical Research Ltd
Nedlands, Western Australia, 6009
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Orally Administered VG290131 in Healthy Adult Subjects
This is a randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability and PK profiles of orally administered VG290131 in healthy subjects. The main questions it aims to answer are:
- The safety and tolerability of VG290131 when administered orally as a single dose and multiple doses in healthy subjects.
- The pharmacokinetic (PK) profiles of VG290131 and the food effect on the PK profiles of VG290131 in healthy subjects.
Approximately 86 subjects will be enrolled in the study.
- Conditions
- Healthy Volunteers
- Being tested
- VG290131
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VG290131Drug
The study drug and matching placebo will be administered orally.
| Study group | Role | What they receive |
|---|---|---|
| SAD Cohort 1 | Experimental | In SAD Cohort 1, 8 subjects will be randomized to receive a single dose of VG290131 (1 mg) (n=6) or matching placebo (n=2), respectively. To ensure the safety of the subjects, two sentinel subjects will be enrolled first: one subject will be randomized to receive VG290131, and the other subject will be randomized to receive a placebo. After the investigator reviews safety/tolerability information available on the sentinel subjects after 24 h and no significant safety issues are observed, the subsequent subjects in the cohort will be randomized to receive VG290131 (n=5) and placebo (n=1). Receives: Drug: VG290131 |
| SAD Cohort 2 (FE Study) | Experimental | SAD Cohort 2 (FE study) is a two-sequence, two-period crossover study. A total of 14 healthy subjects will be randomized to two dosing sequences in a 1:1 ratio. Subjects in sequence 1 will receive a single dose of VG290131 (5 mg) or placebo under fasted condition in Period 1 and under fed condition in Period 2. Subjects in sequence 2 will be administered under fed condition in Period 1 and under fasted condition in Period 2. There will be a 7-day washout between the two dosing periods. Two sentinel subjects will be enrolled in the two dosing sequences of Period 1, respectively: one subject will be randomized to receive VG290131 (5 mg), and the other subject will be randomized to receive placebo. After the investigator reviews safety/tolerability information on the sentinel subjects after 24 h and no significant safety issues are observed, the subsequent subjects in that sequences will be randomized to receive VG290131 (n=4) and placebo (n=1). No sentinel subjects in Period 2. Receives: Drug: VG290131 |
| SAD Cohort 3 | Experimental | In SAD Cohort 3, 8 subjects will be randomized to receive a single dose of VG290131 (25 mg) (n=6) or matching placebo (n=2), respectively. To ensure the safety of the subjects, two sentinel subjects will be enrolled first: one subject will be randomized to receive VG290131, and the other subject will be randomized to receive a placebo. After the investigator reviews safety/tolerability information available on the sentinel subjects after 24 h and no significant safety issues are observed, the subsequent subjects in the cohort will be randomized to receive VG290131 (n=5) and placebo (n=1). Receives: Drug: VG290131 |
| SAD Cohort 4 | Experimental | In SAD Cohort 4, 8 subjects will be randomized to receive a single dose of VG290131 (50 mg) (n=6) or matching placebo (n=2), respectively. To ensure the safety of the subjects, two sentinel subjects will be enrolled first: one subject will be randomized to receive VG290131, and the other subject will be randomized to receive a placebo. After the investigator reviews safety/tolerability information available on the sentinel subjects after 24 h and no significant safety issues are observed, the subsequent subjects in the cohort will be randomized to receive VG290131 (n=5) and placebo (n=1). Receives: Drug: VG290131 |
| SAD Cohort 5 | Experimental | In SAD Cohort 5, 8 subjects will be randomized to receive a single dose of VG290131 (100 mg) (n=6) or matching placebo (n=2), respectively. To ensure the safety of the subjects, two sentinel subjects will be enrolled first: one subject will be randomized to receive VG290131, and the other subject will be randomized to receive a placebo. After the investigator reviews safety/tolerability information available on the sentinel subjects after 24 h and no significant safety issues are observed, the subsequent subjects in the cohort will be randomized to receive VG290131 (n=5) and placebo (n=1). Receives: Drug: VG290131 |
| SAD Cohort 6 | Experimental | In SAD Cohort 6, 8 subjects will be randomized to receive a single dose of VG290131 (200 mg) (n=6) or matching placebo (n=2), respectively. To ensure the safety of the subjects, two sentinel subjects will be enrolled first: one subject will be randomized to receive VG290131, and the other subject will be randomized to receive a placebo. After the investigator reviews safety/tolerability information available on the sentinel subjects after 24 h and no significant safety issues are observed, the subsequent subjects in the cohort will be randomized to receive VG290131 (n=5) and placebo (n=1). Receives: Drug: VG290131 |
| MAD Cohort 1 | Experimental | In MAD Cohort 1, 8 subjects will be randomized 3:1 to receive a once or twice daily dose of VG290131 (1 mg) (n=6) or matching placebo (n=2) for 7 consecutive days depending on the PK profiles of the SAD study, respectively. Receives: Drug: VG290131 |
| MAD Cohort 2 | Experimental | In MAD Cohort 1, 8 subjects will be randomized 3:1 to receive a once or twice daily dose of VG290131 (5 mg) (n=6) or matching placebo (n=2) for 7 consecutive days depending on the PK profiles of the SAD study, respectively. Receives: Drug: VG290131 |
| MAD Cohort 3 | Experimental | In MAD Cohort 1, 8 subjects will be randomized 3:1 to receive a once or twice daily dose of VG290131 (25 mg) (n=6) or matching placebo (n=2) for 7 consecutive days depending on the PK profiles of the SAD study, respectively. Receives: Drug: VG290131 |
| MAD Cohort 4 | Experimental | In MAD Cohort 1, 8 subjects will be randomized 3:1 to receive a once or twice daily dose of VG290131 (100 mg) (n=6) or matching placebo (n=2) for 7 consecutive days depending on the PK profiles of the SAD study, respectively. Receives: Drug: VG290131 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of VG290131 by TEAEs
To evaluate the safety and tolerability of VG290131 after SAD and MAD doses to healthy volunteers by assessing the incidence, severity, and causality of treatment-emergent adverse events (TEAEs).
Measured: From admission to discharge, up to 12 days.
To evaluate the safety and tolerability of VG290131 by 12-Lead ECG
To evaluate the safety and tolerability of VG290131 after SAD and MAD doses to healthy volunteers by assessing the number and percentage of subjects with clinically significant changes in 12-Lead ECG (RR, PR, QRSD, QT, and QTc).
Measured: From admission to discharge, up to 12 days.
To evaluate the safety and tolerability of VG290131 by vital signs
To evaluate the safety and tolerability of VG290131 after SAD and MAD doses to healthy volunteers by assessing the number and percentage of subjects with clinically significant changes in vital signs (Blood pressure, heart rate, body temperature, and respiration rate).
Measured: From admission to discharge, up to 12 days.
To evaluate the safety and tolerability of VG290131 by physical examinations
To evaluate the safety and tolerability of VG290131 after SAD and MAD doses to healthy volunteers by assessing the number and percentage of subjects with clinically significant changes in physical examinations (Skin and mucosa, lymph nodes, head, eyes, ears, nose, and throat (HEENT), chest, abdomen, spine and limbs, musculoskeletal system, and nervous system).
Measured: From admission to discharge, up to 12 days.
To evaluate the safety and tolerability of VG290131 by clinical laboratory tests
To evaluate the safety and tolerability of VG290131 after SAD and MAD doses to healthy volunteers by assessing the number and percentage of subjects with clinically significant changes in clinical laboratory tests (hematology, coagulation, biochemistry and urine analysis).
Measured: From admission to discharge, up to 12 days.
Secondary outcomes (14)
To evaluate PK parameter Cmax of VG290131 after a single dose
Cmax of VG290131 under fasted and fed conditions will be calculated after a single dose.
Measured: From admission to discharge, up to 12 days.
To evaluate PK parameter Tmax of VG290131 after a single dose
Tmax of VG290131 under fasted and fed conditions will be calculated after a single dose.
Measured: From admission to discharge, up to 12 days.
To evaluate PK parameter AUC0-t of VG290131 after a single dose
AUC0-t of VG290131 under fasted and fed conditions will be calculated after a single dose.
Measured: From admission to discharge, up to 12 days.
To evaluate PK parameter AUC0-inf of VG290131 after a single dose
AUC0-inf of VG290131 under fasted and fed conditions will be calculated after a single dose.
Measured: From admission to discharge, up to 12 days.
To evaluate PK parameter t1/2 of VG290131 after a single dose
t1/2 of VG290131 under fasted and fed conditions will be calculated after a single dose.
Measured: From admission to discharge, up to 12 days.
To evaluate PK parameter CL/F of VG290131 after a single dose
CL/F of VG290131 under fasted and fed conditions will be calculated after a single dose.
Measured: From admission to discharge, up to 12 days.
To evaluate PK parameter Vz/F of VG290131 after a single dose
Vz/F of VG290131 under fasted and fed conditions will be calculated after a single dose.
Measured: From admission to discharge, up to 12 days.
To evaluate PK parameter MRT of VG290131 after a single dose
MRT of VG290131 under fasted and fed conditions will be calculated after a single dose.
Measured: From admission to discharge, up to 12 days.
To evaluate PK parameter λz of VG290131 after a single dose
λz of VG290131 under fasted and fed conditions will be calculated after a single dose.
Measured: From admission to discharge, up to 12 days.
To evaluate PK parameter Cmax,ss of VG290131 after multiple doses
The maximum observed concentration at steady state (Cmax,ss) of VG290131 will be calculated after multiple doses from Day 1 to Day 7.
Measured: From admission to discharge, up to 12 days.
To evaluate PK parameter Cmin,ss of VG290131 after multiple doses
The minimum observed concentration at steady state (Cmin,ss) of VG290131 will be calculated after multiple doses from Day 1 to Day 7.
Measured: From admission to discharge, up to 12 days.
To evaluate PK parameter Cav,ss of VG290131 after multiple doses
The average concentration during a dosing interval at steady state (Cav,ss) of VG290131 will be calculated after multiple doses from Day 1 to Day 7.
Measured: From admission to discharge, up to 12 days.
To evaluate PK parameter AUCss of VG290131 after multiple doses
The area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss) of VG290131 will be calculated after multiple doses from Day 1 to Day 7.
Measured: From admission to discharge, up to 12 days.
To evaluate PK parameter Rac of VG290131 after multiple doses
The accumulation ratio (Rac) of VG290131 will be calculated after multiple doses from Day 1 to Day 7.
Measured: From admission to discharge, up to 12 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start20 Oct 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The study consists of three parts: a single ascending dose (SAD) part, a multiple ascending dose (MAD) part and a food effect (FE) part. The FE study is incorporated as part of the SAD study. Approximately 86 subjects will be enrolled in the study. SAD+FE study: 6 cohorts (1, 5, 25, 50, 100, and 200 mg), 8 subjects in each cohort, except that there are 14 subjects in the 5 mg cohort, which is the FE study cohort. MAD study: 4 cohorts (1, 5, 25, and 100 mg), 8 subjects in each cohort.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Vimgreen Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081465
- Sponsor's protocol ID
- VG290131-AU-001
- Status last verified
- Jul 2024
- First submitted
- 30 Sep 2023
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Orally Administered VG290131 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06081465
- Acronym / sponsor ID
- VG290131-AU-001
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Zhejiang Vimgreen Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability and PK profiles of orally administered VG290131 in healthy subjects. The main questions it aims to answer are:
- The safety and tolerability of VG290131 when administered orally as a single dose and multiple doses in healthy subjects.
- The pharmacokinetic (PK) profiles of VG290131 and the food effect on the PK profiles of VG290131 in healthy subjects.
Approximately 86 subjects will be enrolled in the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
- Model description
- The study consists of three parts: a single ascending dose (SAD) part, a multiple ascending dose (MAD) part and a food effect (FE) part. The FE study is incorporated as part of the SAD study. Approximately 86 subjects will be enrolled in the study. SAD+FE study: 6 cohorts (1, 5, 25, 50, 100, and 200 mg), 8 subjects in each cohort, except that there are 14 subjects in the 5 mg cohort, which is the FE study cohort. MAD study: 4 cohorts (1, 5, 25, and 100 mg), 8 subjects in each cohort.
| Arm | Type | Receives |
|---|---|---|
| SAD Cohort 1 | Experimental | Drug: VG290131In SAD Cohort 1, 8 subjects will be randomized to receive a single dose of VG290131 (1 mg) (n=6) or matching placebo (n=2), respectively. To ensure the safety of the subjects, two sentinel subjects will be enrolled first: one subject will be randomized to receive VG290131, and the other subject will be randomized to receive a placebo. After the investigator reviews safety/tolerability information available on the sentinel subjects after 24 h and no significant safety issues are observed, the subsequent subjects in the cohort will be randomized to receive VG290131 (n=5) and placebo (n=1). |
| SAD Cohort 2 (FE Study) | Experimental | Drug: VG290131SAD Cohort 2 (FE study) is a two-sequence, two-period crossover study. A total of 14 healthy subjects will be randomized to two dosing sequences in a 1:1 ratio. Subjects in sequence 1 will receive a single dose of VG290131 (5 mg) or placebo under fasted condition in Period 1 and under fed condition in Period 2. Subjects in sequence 2 will be administered under fed condition in Period 1 and under fasted condition in Period 2. There will be a 7-day washout between the two dosing periods. Two sentinel subjects will be enrolled in the two dosing sequences of Period 1, respectively: one subject will be randomized to receive VG290131 (5 mg), and the other subject will be randomized to receive placebo. After the investigator reviews safety/tolerability information on the sentinel subjects after 24 h and no significant safety issues are observed, the subsequent subjects in that sequences will be randomized to receive VG290131 (n=4) and placebo (n=1). No sentinel subjects in Period 2. |
| SAD Cohort 3 | Experimental | Drug: VG290131In SAD Cohort 3, 8 subjects will be randomized to receive a single dose of VG290131 (25 mg) (n=6) or matching placebo (n=2), respectively. To ensure the safety of the subjects, two sentinel subjects will be enrolled first: one subject will be randomized to receive VG290131, and the other subject will be randomized to receive a placebo. After the investigator reviews safety/tolerability information available on the sentinel subjects after 24 h and no significant safety issues are observed, the subsequent subjects in the cohort will be randomized to receive VG290131 (n=5) and placebo (n=1). |
| SAD Cohort 4 | Experimental | Drug: VG290131In SAD Cohort 4, 8 subjects will be randomized to receive a single dose of VG290131 (50 mg) (n=6) or matching placebo (n=2), respectively. To ensure the safety of the subjects, two sentinel subjects will be enrolled first: one subject will be randomized to receive VG290131, and the other subject will be randomized to receive a placebo. After the investigator reviews safety/tolerability information available on the sentinel subjects after 24 h and no significant safety issues are observed, the subsequent subjects in the cohort will be randomized to receive VG290131 (n=5) and placebo (n=1). |
| SAD Cohort 5 | Experimental | Drug: VG290131In SAD Cohort 5, 8 subjects will be randomized to receive a single dose of VG290131 (100 mg) (n=6) or matching placebo (n=2), respectively. To ensure the safety of the subjects, two sentinel subjects will be enrolled first: one subject will be randomized to receive VG290131, and the other subject will be randomized to receive a placebo. After the investigator reviews safety/tolerability information available on the sentinel subjects after 24 h and no significant safety issues are observed, the subsequent subjects in the cohort will be randomized to receive VG290131 (n=5) and placebo (n=1). |
| SAD Cohort 6 | Experimental | Drug: VG290131In SAD Cohort 6, 8 subjects will be randomized to receive a single dose of VG290131 (200 mg) (n=6) or matching placebo (n=2), respectively. To ensure the safety of the subjects, two sentinel subjects will be enrolled first: one subject will be randomized to receive VG290131, and the other subject will be randomized to receive a placebo. After the investigator reviews safety/tolerability information available on the sentinel subjects after 24 h and no significant safety issues are observed, the subsequent subjects in the cohort will be randomized to receive VG290131 (n=5) and placebo (n=1). |
| MAD Cohort 1 | Experimental | Drug: VG290131In MAD Cohort 1, 8 subjects will be randomized 3:1 to receive a once or twice daily dose of VG290131 (1 mg) (n=6) or matching placebo (n=2) for 7 consecutive days depending on the PK profiles of the SAD study, respectively. |
| MAD Cohort 2 | Experimental | Drug: VG290131In MAD Cohort 1, 8 subjects will be randomized 3:1 to receive a once or twice daily dose of VG290131 (5 mg) (n=6) or matching placebo (n=2) for 7 consecutive days depending on the PK profiles of the SAD study, respectively. |
| MAD Cohort 3 | Experimental | Drug: VG290131In MAD Cohort 1, 8 subjects will be randomized 3:1 to receive a once or twice daily dose of VG290131 (25 mg) (n=6) or matching placebo (n=2) for 7 consecutive days depending on the PK profiles of the SAD study, respectively. |
| MAD Cohort 4 | Experimental | Drug: VG290131In MAD Cohort 1, 8 subjects will be randomized 3:1 to receive a once or twice daily dose of VG290131 (100 mg) (n=6) or matching placebo (n=2) for 7 consecutive days depending on the PK profiles of the SAD study, respectively. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- A subject will be eligible for inclusion in this study only if all of the following criteria are met:
- Willing to comply with protocol required visit schedule and visit requirements and provide written ICF;
- Healthy adult male and female subjects, aged 18 to 45 years of age (inclusive) at the time of signing the ICF;
- Body mass index between 18.0 and 32.0 kg/m2, inclusive;
- Considered medically healthy as determined by the investigator, based on medical history and clinical evaluations including physical examination, clinical laboratory tests, vital sign measurements, and 12-Lead ECG;
Key exclusion criteria (27 listed)
- A subject meeting any of the following exclusion criteria will not be allowed to participate in this study:
- Ascertained or presumptive hypersensitivity (including allergies) to any ingredient of the VG290131; history of other significant allergies or anaphylaxis, as determined by the investigator;
- Considered by the investigator to be ineligible for the study due to a history of or current condition of significant metabolic or endocrine, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological, immunological, neurological, or psychiatric disorders with clinical manifestations;
- Active or history of serious mental illness or psychiatric disorder, including but not limited to schizophrenia, bipolar disorder, or severe depression, which require current pharmacological intervention;
- History of stomach or intestinal surgery or resection diseases including but not limited to, gastric band/gastric resection and/or intestinal resection and/or duodenal disease (i.e. celiac disease) which may potentially alter absorption and/or excretion of VG290131 (except for an appendectomy);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VG290131The study drug and matching placebo will be administered orally. | Drug | MAD Cohort 1, MAD Cohort 2, MAD Cohort 3, MAD Cohort 4, SAD Cohort 1, SAD Cohort 2 (FE Study), SAD Cohort 3, SAD Cohort 4, SAD Cohort 5, SAD Cohort 6 |
Primary outcome
To evaluate the safety and tolerability of VG290131 by TEAEs
Time frame: From admission to discharge, up to 12 days.
To evaluate the safety and tolerability of VG290131 after SAD and MAD doses to healthy volunteers by assessing the incidence, severity, and causality of treatment-emergent adverse events (TEAEs).
To evaluate the safety and tolerability of VG290131 by 12-Lead ECG
Time frame: From admission to discharge, up to 12 days.
To evaluate the safety and tolerability of VG290131 after SAD and MAD doses to healthy volunteers by assessing the number and percentage of subjects with clinically significant changes in 12-Lead ECG (RR, PR, QRSD, QT, and QTc).
To evaluate the safety and tolerability of VG290131 by vital signs
Time frame: From admission to discharge, up to 12 days.
To evaluate the safety and tolerability of VG290131 after SAD and MAD doses to healthy volunteers by assessing the number and percentage of subjects with clinically significant changes in vital signs (Blood pressure, heart rate, body temperature, and respiration rate).
To evaluate the safety and tolerability of VG290131 by physical examinations
Time frame: From admission to discharge, up to 12 days.
To evaluate the safety and tolerability of VG290131 after SAD and MAD doses to healthy volunteers by assessing the number and percentage of subjects with clinically significant changes in physical examinations (Skin and mucosa, lymph nodes, head, eyes, ears, nose, and throat (HEENT), chest, abdomen, spine and limbs, musculoskeletal system, and nervous system).
To evaluate the safety and tolerability of VG290131 by clinical laboratory tests
Time frame: From admission to discharge, up to 12 days.
To evaluate the safety and tolerability of VG290131 after SAD and MAD doses to healthy volunteers by assessing the number and percentage of subjects with clinically significant changes in clinical laboratory tests (hematology, coagulation, biochemistry and urine analysis).
14 secondary outcomes
To evaluate PK parameter Cmax of VG290131 after a single dose
Time frame: From admission to discharge, up to 12 days.
To evaluate PK parameter Tmax of VG290131 after a single dose
Time frame: From admission to discharge, up to 12 days.
To evaluate PK parameter AUC0-t of VG290131 after a single dose
Time frame: From admission to discharge, up to 12 days.
To evaluate PK parameter AUC0-inf of VG290131 after a single dose
Time frame: From admission to discharge, up to 12 days.
To evaluate PK parameter t1/2 of VG290131 after a single dose
Time frame: From admission to discharge, up to 12 days.
To evaluate PK parameter CL/F of VG290131 after a single dose
Time frame: From admission to discharge, up to 12 days.
To evaluate PK parameter Vz/F of VG290131 after a single dose
Time frame: From admission to discharge, up to 12 days.
To evaluate PK parameter MRT of VG290131 after a single dose
Time frame: From admission to discharge, up to 12 days.
To evaluate PK parameter λz of VG290131 after a single dose
Time frame: From admission to discharge, up to 12 days.
To evaluate PK parameter Cmax,ss of VG290131 after multiple doses
Time frame: From admission to discharge, up to 12 days.
To evaluate PK parameter Cmin,ss of VG290131 after multiple doses
Time frame: From admission to discharge, up to 12 days.
To evaluate PK parameter Cav,ss of VG290131 after multiple doses
Time frame: From admission to discharge, up to 12 days.
To evaluate PK parameter AUCss of VG290131 after multiple doses
Time frame: From admission to discharge, up to 12 days.
To evaluate PK parameter Rac of VG290131 after multiple doses
Time frame: From admission to discharge, up to 12 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VG290131 in people with Healthy Volunteers, run by Zhejiang Vimgreen Pharmaceuticals, Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Ana Liza Sun (+61 8 6382 5100, asun@linear.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of VG290131 by TEAEs (time frame: From admission to discharge, up to 12 days.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024; AzTrials last refreshed its copy on 3 Nov 2026.