Healthy ParticipantsPhase 1NCT07885202
Study of the Safety, Tolerability, Pharmacokinetics of VV147 Tablets in Chinese Healthy Participants.
A Phase 1 study testing VV147 15mg Group, VV147 30mg Group and VV147 60mg Group in people with Healthy Participants, run by Vigonvita Life Sciences.
Trial summary
This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose study designed to evaluate the safety, tolerability, and pharmacokinetic characteristics of VV147 tablets in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- VV147 15mg Group, VV147 30mg Group and VV147 60mg Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2026to 30 Aug 2027
- Phase
- Phase 1
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
- Aged 18 to 45 years old, males or females;
- Males weight no less than 50 kg, females weight no less than 45 kg, with body mass index of 19.0 to 26.0 kg/m² (inclusive of 19.0 and 26.0);
- Female participants of childbearing potential must have a negative pregnancy test，all participants (including males) must agree not to plan a pregnancy or donate sperm/ova from 14 days prior to dosing until 3 months after the study ends, and must voluntarily adopt effective contraceptive measures;
- Participants who are able to understand and follow the study protocol and instructions and volunteers who have voluntarily decided to participate in this study, and sign the informed consent form.
Who cannot join
- Participants with hypersensitivity to preparation or any of the excipients, or allergies to two or more types of foods, drugs, or specific substances;
- Participants with central nervous, cardiovascular, digestive, endocrine, respiratory, urinary, immune, or hematologic systems; or confirmed renal, hepatic, or metabolic abnormalities requiring medical intervention，or other conditions deemed by the investigator to make the subject unsuitable for the clinical trial (e.g., a history of malignant tumors);
- Participants with a history of epileptic seizures;
- Past or current neuropsychiatric disorders (e.g., depression, mania, schizophrenia), a family history of neuropsychiatric disorders, a history of suicidal behavior, or suicidal ideation or risk as assessed by the investigator using the Columbia-Suicide Severity Rating Scale (C-SSRS);
- Participation in other clinical trials of drugs or medical devices within the 3 months prior to screening;
- Participants who have donated blood or experienced blood loss of ≥400 mL within 3 months prior to screening, have a history of using blood products, or plan to donate blood during the trial or within 3 months after the last dose of the study drug;
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- Participants who have undergone major surgery or surgery likely to significantly affect the in vivo behavior of the study drug or safety assessments (e.g., gastrointestinal resection, cholecystectomy, or other surgeries affecting drug absorption or metabolism) within 3 months prior to screening, or who plan to undergo surgery during the study or within 2 weeks after the study ends;
- Participants who have taken any prescription drugs, over-the-counter (OTC) medications, herbal medicines, or dietary supplements within 2 weeks prior to screening;
- Participants who have received a vaccination within 14 days prior to screening, or plan to receive a vaccination within 1 week after the study ends;
- Participants who test positive in a drug abuse screen, or have a history of drug abuse or illicit drug use within 1 year prior to screening;
- Participants with alcohol addiction;(those who drink at least twice daily or consume more than 14 units of alcohol per week),or those who engage in binge drinking ,or those who test positive in a breath alcohol test, or those unable to abstain from alcohol or alcohol-containing products from the time of screening through the duration of the clinical trial;
- Participants who smoked within 1 year prior to screening (consuming more than 10 cigarettes or an equivalent amount of tobacco daily), or unable to abstain from using tobacco products from screening through the clinical trial period;
- Unable to tolerate venipuncture or having difficulty with blood sampling, or a history of needle phobia or fainting at the sight of blood;
- Consumed excessive amounts (more than 5 cups; 1 cup ≈ 250 mL) of tea, coffee, or caffeine-containing foods or beverages daily within 3 months prior to screening, or unwilling to abstain from consuming tea, coffee, or caffeine-containing foods or beverages during the trial;
- Unable to abstain from strenuous exercise during the trial;
- Has special dietary requirements and cannot adhere to the standardized diet, or has difficulty swallowing tablets;
- Tests positive for Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (Anti-HCV), *Treponema pallidum* antibody, or HIV antibody;
- Clinically significant abnormalities in vital signs, physical examination, or laboratory tests;
- Clinically significant abnormalities in chest X-ray (posteroanterior view);
- Clinically significant abnormalities in abdominal ultrasound (liver, gallbladder, pancreas, spleen, kidneys);
- Clinically significant abnormalities in 12-lead ECG, or corrected QT interval (QTcF) > 450 ms (calculated using Fridericia's formula);
- Pregnant or lactating women;
- Any other factors deemed by the investigator to make the participants who unsuitable for participation in the trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics of a Single Oral Dose of VV147 Tablets in Chinese Healthy Participants.
This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose study designed to evaluate the safety, tolerability, and pharmacokinetic characteristics of VV147 tablets in healthy participants.
Read the detailed description
This study plans to enroll 48 participants using a randomized, double-blind, placebo-controlled design comprising six dose groups of eight participants each, participants will be randomized to the VV147 group or the placebo group in a 3:1 ratio. The study's dose groups are 15 mg, 30 mg, 60 mg, 90 mg, 120 mg and 150 mg, with subsequent dose levels subject to adjustment based on the tolerability and safety profiles of completed dose groups or obtained pharmacokinetic (PK) data.
- Conditions
- Healthy Participants
- Being tested
- VV147 15mg Group, VV147 30mg Group, VV147 60mg Group, VV147 90mg Group, VV147 120mg Group
- Keywords
- VV147, Phase I
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VV147 15mg GroupDrug
6 participants receive VV147 15mg,orally; 2 participants will receive placebo,orally
VV147 30mg GroupDrug
6 participants receive VV147 30mg,orally; 2 participants will receive placebo,orally
VV147 60mg GroupDrug
6 participants receive VV147 60mg,orally; 2 participants will receive placebo,orally
VV147 90mg GroupDrug
6 participants receive VV147 90mg,orally; 2 participants will receive placebo,orally
VV147 120mg GroupDrug
6 participants receive VV147 120mg,orally; 2 participants will receive placebo,orally
VV147 150mg GroupDrug
6 participants receive VV147 150mg,orally; 2 participants will receive placebo,orally
| Study group | Role | What they receive |
|---|---|---|
| VV147 | Experimental | Not described Receives: Drug: VV147 15mg Group; Drug: VV147 30mg Group; Drug: VV147 60mg Group; Drug: VV147 90mg Group; Drug: VV147 120mg Group; Drug: VV147 150mg Group |
| Placebo | Placebo comparator | Not described Receives: Drug: VV147 15mg Group; Drug: VV147 30mg Group; Drug: VV147 60mg Group; Drug: VV147 90mg Group; Drug: VV147 120mg Group; Drug: VV147 150mg Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
maximum observed plasma concentration
Measured: 168 hours after administration
AUC0-t
area under the plasma concentration time curve from time zero to the last measurable concentration
Measured: 168 hours after administration
AUC0-∞
area under the plasma concentration-time curve from time zero to infinity
Measured: 168 hours after administration
AUC0-24
Area under the plasma concentration time curve from time zero to 24 hours
Measured: 24 hours after administration
Tmax
time at which Cmax occurs
Measured: 168 hours after administration
t1/2
half life of elimination
Measured: 168 hours after administration
Ke
elimination rate constant
Measured: 168 hours after administration
CL/F
apparent clearance
Measured: 168 hours after administration
Vd/F
apparent volume of distribution during the terminal phase
Measured: 168 hours after administration
MRT
mean residence time
Measured: 168 hours after administration
Blood-to-plasma concentration ratio
The ratio of drug concentration in whole blood to that in plasma at equilibrium
Measured: 168 hours after administration
Plasma protein binding
The fraction of total drug in plasma that is reversibly bound to plasma proteins
Measured: 168 hours after administration
AE & SAE
Adverse event \& serious adverse events
Measured: from day1 to day14 after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vigonvita Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885202
- Sponsor's protocol ID
- VV147-01
- Status last verified
- Sep 2026
- First submitted
- 9 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No