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Not yet recruitingNCT07885202Updated Oct 21, 2026

Study of the Safety, Tolerability, Pharmacokinetics of VV147 Tablets in Chinese Healthy Participants.

A Phase 1 interventional study of VV147 15mg Group and VV147 30mg Group in Healthy Participants, sponsored by Vigonvita Life Sciences. Not yet recruiting. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.

Sponsored by Vigonvita Life Sciences · Phase 1, Interventional, and Treatment

Updated Oct 21, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Healthy Participants

Keywords

  • VV147
  • Phase I
03

In context

Lead sponsor

Vigonvita Life Sciences is the lead sponsor of 37 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged 18 to 45 years old, males or females;
  2. 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);
  3. 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;
  4. 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.

Exclusion criteria

Exclusion Criteria:

  1. Participants with hypersensitivity to preparation or any of the excipients, or allergies to two or more types of foods, drugs, or specific substances;
  2. 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);
  3. Participants with a history of epileptic seizures;
  4. 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);
  5. Participation in other clinical trials of drugs or medical devices within the 3 months prior to screening;
  6. 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;
  7. 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;
  8. Participants who have taken any prescription drugs, over-the-counter (OTC) medications, herbal medicines, or dietary supplements within 2 weeks prior to screening;
  9. 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;
  10. 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;
  11. 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;
  12. 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;
  13. Unable to tolerate venipuncture or having difficulty with blood sampling, or a history of needle phobia or fainting at the sight of blood;
  14. 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;
  15. Unable to abstain from strenuous exercise during the trial;
  16. Has special dietary requirements and cannot adhere to the standardized diet, or has difficulty swallowing tablets;
  17. Tests positive for Hepatitis B surface antigen (HBsAg), Hepatitis C virus antibody (Anti-HCV), *Treponema pallidum* antibody, or HIV antibody;
  18. Clinically significant abnormalities in vital signs, physical examination, or laboratory tests;
  19. Clinically significant abnormalities in chest X-ray (posteroanterior view);
  20. Clinically significant abnormalities in abdominal ultrasound (liver, gallbladder, pancreas, spleen, kidneys);
  21. Clinically significant abnormalities in 12-lead ECG, or corrected QT interval (QTcF) > 450 ms (calculated using Fridericia's formula);
  22. Pregnant or lactating women;
  23. Any other factors deemed by the investigator to make the participants who unsuitable for participation in the trial.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    VV147

    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 comparator
    Placebo

    Drug: VV147 15mg Group · Drug: VV147 30mg Group · Drug: VV147 60mg Group · Drug: VV147 90mg Group · Drug: VV147 120mg Group · Drug: VV147 150mg Group

Interventions

  • DrugVV147 15mg Group

    6 participants receive VV147 15mg,orally; 2 participants will receive placebo,orally

  • DrugVV147 30mg Group

    6 participants receive VV147 30mg,orally; 2 participants will receive placebo,orally

  • DrugVV147 60mg Group

    6 participants receive VV147 60mg,orally; 2 participants will receive placebo,orally

  • DrugVV147 90mg Group

    6 participants receive VV147 90mg,orally; 2 participants will receive placebo,orally

  • DrugVV147 120mg Group

    6 participants receive VV147 120mg,orally; 2 participants will receive placebo,orally

  • DrugVV147 150mg Group

    6 participants receive VV147 150mg,orally; 2 participants will receive placebo,orally

06

What researchers measure

Primary outcomes

  1. Cmax

    maximum observed plasma concentration

    Time frame: 168 hours after administration

  2. AUC0-t

    area under the plasma concentration time curve from time zero to the last measurable concentration

    Time frame: 168 hours after administration

  3. AUC0-∞

    area under the plasma concentration-time curve from time zero to infinity

    Time frame: 168 hours after administration

  4. AUC0-24

    Area under the plasma concentration time curve from time zero to 24 hours

    Time frame: 24 hours after administration

  5. Tmax

    time at which Cmax occurs

    Time frame: 168 hours after administration

  6. t1/2

    half life of elimination

    Time frame: 168 hours after administration

  7. Ke

    elimination rate constant

    Time frame: 168 hours after administration

  8. CL/F

    apparent clearance

    Time frame: 168 hours after administration

  9. Vd/F

    apparent volume of distribution during the terminal phase

    Time frame: 168 hours after administration

  10. MRT

    mean residence time

    Time frame: 168 hours after administration

  11. Blood-to-plasma concentration ratio

    The ratio of drug concentration in whole blood to that in plasma at equilibrium

    Time frame: 168 hours after administration

  12. Plasma protein binding

    The fraction of total drug in plasma that is reversibly bound to plasma proteins

    Time frame: 168 hours after administration

  13. AE & SAE

    Adverse event \& serious adverse events

    Time frame: from day1 to day14 after administration

07

Study locations

No study locations are listed for this record.

08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for May 2027, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2026
First posted
Oct 21, 2026
StartEst.
Oct 20, 2026
Primary completionEst.
May 30, 2027
CompletionEst.
Aug 30, 2027
Last update
Oct 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 21, 2026
Show all 1 update
  1. Oct 21, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07885202
Responsible party
Sponsor
First posted
Oct 21, 2026
Start date
Oct 20, 2026 (estimated)
Primary completion
May 30, 2027 (estimated)
Completion
Aug 30, 2027 (estimated)
Last update
Oct 21, 2026

Study contacts

Huaqing Duan
Contact
huaqing.duan@vigonvita.cn
18061926005

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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