Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV913 Capsules

NCT07507838 | Not Yet Recruiting Early Phase 1

• 1 other identifier: VV913-02
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a single-center, randomized, double-blind, placebo-controlled, dose-escalation trial to assess the safety, tolerability, pharmacokinetics （PK） of multiple doses of VV913 in Chinese healthy adult participants.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (11)

• Incidence of Treatment-Emergent Adverse Events

  Incidence of Treatment-Emergent Adverse Events

  Baseline to 6 days after the last administration

• Cmax

  maximum observed plasma concentration

  Baseline to 72 hours after the last administration

• AUC0-∞

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

  Baseline to 72 hours after the last administration

• Tmax

  time at which Cmax occurs

  Baseline to 72 hours after the last administration

• t1/2

  half-life of elimination

  Baseline to 72 hours after the last administration

• Apparent Clearance Rate（CL/F）

  apparent clearance

  Baseline to 72 hours after the last administration

• Vd/F

  apparent volume of distribution during the terminal phase

  Baseline to 72 hours after the last administration

• λz

  elimination rate constant

  Baseline to 72 hours after the last administration

• AUC0-24h

  area under the plasma concentration time curve from time zero to 24h

  Baseline to 72 hours after the last administration

• mean Resident Time

  mean Resident Time from time zero to infinity/the last

  Baseline to 72 hours after the last administration

• Rac

  Accumulation Ratio of VV913

  Baseline to 72 hours after the last administration

Study Arms (2)

VV913

EXPERIMENTAL

Drug: VV913 4mg group; Drug: VV913 8mg group; Drug: VV913 15mg group

Placebo

PLACEBO COMPARATOR

Drug: VV913 4mg group; Drug: VV913 8mg group; Drug: VV913 15mg group

Interventions

VV913 4mg group DRUG

6 participants will receive VV913 4mg orally; 2 participants will receive placebo orally.

Placebo; VV913

VV913 8mg group DRUG

6 participants will receive VV913 8mg orally; 2 participants will receive placebo orally.

Placebo; VV913

VV913 15mg group DRUG

6 participants will receive VV913 15mg orally; 2 participants will receive placebo orally.

Placebo; VV913

Eligibility Criteria

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

You may qualify if:

• Aged 18 to 45 years old, males ;
• Males weight no less than 50 kg, with body mass index of 19 to 26 kg/m\^2;
• Vital signs examination, physical examination, laboratory examination ,Chest X-ray are normal or considered abnormal without clinical significance by the investigator;
• Participants who are willing to take proper contraceptive methods during the study and within 3 months after the the last administration;
• Participants who are able to understand and follow the study protocol and instructions; participants 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;
• Participants with allergic constitution (such as asthma, urticaria, eczematous dermatitis and other allergic diseases), or have a history of drug or food allergy;
• Participants with central nervous system, cardiovascular system, gastrointestinal, respiratory system, urinary, hematologic, or metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials; Participants with a history of gastrointestinal conditions that may impair drug absorption (e.g., gastrectomy or small intestine resection, atrophic gastritis, gastrointestinal ulcers or perforations/fistulas, gastrointestinal bleeding, or obstruction);
• Participants with a history of surgery within 3 months before screening, or have not recovered from surgery, or have an expected surgical plan during the trial;
• Participants with a blood donation or blood loss ≥ 400 mL within 3 months before screening, or a history of blood product use within 3 months before screening;
• Participating in any clinical trial and taking clinical trial drugs within 90 days before screening;
• Participants who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 14 days before screening;
• Participants who have received vaccination within 14 days before screening, or planned to receive any vaccine during the trial or within 1 week after the end of the study;
• Participants with a history of drug abuse within 1 year before screening or positive urine drug screening within 1 year before screening results (morphine, tetrahydrocannabinol, methamphetamine, dimethylene diphenazine , ketamine, and cocaine);
• Participants who drink more than 14 standard units or at least twice a day per week within one year before screening (one standard unit equals 200 mL of beer with 5% alcohol or 25 mL of spirits with 40% alcohol content or 85 mL of wine with 12% alcohol content);
• Participants who smoke more than 5 cigarettes a day within one year before screening;
• Participants who can't quit smoking or drinking during the trial period;
• Participants who are positive for hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody (Anti-HIV）;
• Having special requirements for food, unable to observe a unified diet or having dysphagia;
• Participants who cannot avoid consuming drinks containing xanthine (such as coffee and tea) or foods (such as chocolate and animal liver), or fruits or juices (such as grapefruit, pomelo, mango, and dragon fruit) that may affect drug metabolism，from 48 hours before administration until the end of the study;

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Huan Zhou

  The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huaqing Duan

CONTACT

18061926005; huaqing.duan@vigonvita.cn

Study Design

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

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 2, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share