Actively Recruiting

Phase 1
Age: 18Years - 45Years
MALE
Healthy Volunteers
NCT07372703

Study of the Safety, Tolerability, Pharmacokinetics of VV913 Capsules in Chinese Healthy Participants

Led by Vigonvita Life Sciences · Updated on 2026-05-04

56

Participants Needed

1

Research Sites

35 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a randomized, double-blind, placebo-controlled, single ascending-dose study to evaluate the safety, tolerability and pharmacokinetics characteristics of VV913 Capsules in healthy adults.

CONDITIONS

Official Title

Study of the Safety, Tolerability, Pharmacokinetics of VV913 Capsules in Chinese Healthy Participants

Who Can Participate

Age: 18Years - 45Years
MALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Male participants aged 18 to 45 years
  • Male participants weighing at least 50 kg with a body mass index of 19 to 26 kg/m2
  • Normal or clinically insignificant abnormal results in vital signs, physical exam, lab tests, ECG, and chest CT
  • Willingness to use appropriate contraception during the study and for 3 months after last dose
  • Ability to understand and follow the study protocol and provide signed informed consent
Not Eligible

You will not qualify if you...

  • Hypersensitivity to VV913 or any of its ingredients
  • History of allergies such as asthma, hives, eczema, or drug/food allergies
  • Central nervous system, cardiovascular, gastrointestinal, respiratory, urinary, blood, metabolic, or psychiatric disorders requiring treatment or unsuitable for trial
  • History of gastrointestinal conditions affecting drug absorption or recent major surgery
  • Blood donation or significant blood loss (≥400 mL) or use of blood products within 3 months
  • Participation in other clinical trials or use of investigational drugs within 90 days
  • Use of prescription, over-the-counter, herbal medicines, or health products within 14 days
  • Vaccination within 14 days before screening or planned vaccination during or one week after the study
  • History of drug abuse or positive drug screening within 1 year
  • Excessive alcohol consumption or smoking exceeding set limits within 1 year
  • Inability or unwillingness to quit smoking or drinking during the trial
  • Positive tests for hepatitis B, hepatitis C, syphilis, or HIV
  • Special dietary requirements or inability to follow a standardized diet
  • Inability to avoid foods or drinks affecting drug metabolism during the study
  • Intolerance to blood draws or difficulty swallowing capsules
  • Female partners planning conception within 3 months
  • Any other condition deemed unsuitable by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China, 230031

Actively Recruiting

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Research Team

H

Huaqing Duan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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