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

NCT07885202 | Not Yet Recruiting Phase 1

• 1 other identifier: VV147-01
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Participants

Keywords

VV147; Phase I

Outcome Measures

Primary Outcomes (13)

• Cmax

  maximum observed plasma concentration

  168 hours after administration

• AUC0-t

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

  168 hours after administration

• AUC0-∞

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

  168 hours after administration

• AUC0-24

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

  24 hours after administration

• Tmax

  time at which Cmax occurs

  168 hours after administration

• t1/2

  half life of elimination

  168 hours after administration

• Ke

  elimination rate constant

  168 hours after administration

• CL/F

  apparent clearance

  168 hours after administration

• Vd/F

  apparent volume of distribution during the terminal phase

  168 hours after administration

• MRT

  mean residence time

  168 hours after administration

• Blood-to-plasma concentration ratio

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

  168 hours after administration

• Plasma protein binding

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

  168 hours after administration

• AE & SAE

  Adverse event \& serious adverse events

  from day1 to day14 after administration

Study Arms (2)

VV147

EXPERIMENTAL

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

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

VV147 15mg Group DRUG

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

Placebo; VV147

VV147 60mg Group DRUG

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

Placebo; VV147

VV147 90mg Group DRUG

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

Placebo; VV147

VV147 150mg Group DRUG

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

Placebo; VV147

VV147 30mg Group DRUG

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

Placebo; VV147

VV147 120mg Group DRUG

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

Placebo; VV147

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Central Study Contacts

Huaqing Duan

CONTACT

18061926005; huaqing.duan@vigonvita.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 21, 2026
• Study Start: October 20, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: October 21, 2026

Record last verified: 2026-09