Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV913 Capsules

Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV913 Capsules in Chinese Healthy Participants

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: VV913 4mg group; Drug: VV913 8mg group; Drug: VV913 15mg group

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Huaqing Duan; Phone Number: 18061926005; Email: huaqing.duan@vigonvita.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Aged 18 to 45 years old, males ;
2. Males weight no less than 50 kg, with body mass index of 19 to 26 kg/m^2;
3. Vital signs examination, physical examination, laboratory examination ,Chest X-ray are normal or considered abnormal without clinical significance by the investigator;
4. Participants who are willing to take proper contraceptive methods during the study and within 3 months after the the last administration;
5. 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.

Exclusion Criteria:

1. Participants with hypersensitivity to preparation or any of the excipients;
2. Participants with allergic constitution (such as asthma, urticaria, eczematous dermatitis and other allergic diseases), or have a history of drug or food allergy;
3. 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);
4. 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;
5. 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;
6. Participating in any clinical trial and taking clinical trial drugs within 90 days before screening;
7. Participants who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 14 days before screening;
8. 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;
9. 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);
10. 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);
11. Participants who smoke more than 5 cigarettes a day within one year before screening;
12. Participants who can't quit smoking or drinking during the trial period;
13. Participants who are positive for hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody (Anti-HIV）;
14. Having special requirements for food, unable to observe a unified diet or having dysphagia;
15. 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;
16. Participants who cannot tolerate blood collection with intravenous indwelling needles or blood fainting;
17. Participants with difficulty in swallowing capsules;
18. Participants whose female partners plan to conceive within 3 months;
19. The investigator believes that there are other unsuitable factors to participate this trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: VV913 4mg group; 6 participants will receive VV913 4mg orally; 2 participants will receive placebo orally.; Drug: VV913 8mg group; 6 participants will receive VV913 8mg orally; 2 participants will receive placebo orally.; Drug: VV913 15mg group; 6 participants will receive VV913 15mg orally; 2 participants will receive placebo orally.
Experimental: VV913	Drug: VV913 4mg group; 6 participants will receive VV913 4mg orally; 2 participants will receive placebo orally.; Drug: VV913 8mg group; 6 participants will receive VV913 8mg orally; 2 participants will receive placebo orally.; Drug: VV913 15mg group; 6 participants will receive VV913 15mg orally; 2 participants will receive placebo orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Vigonvita Life Sciences
• Investigators: Principal Investigator: Huan Zhou, The First Affiliated Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Population Characteristics; Demography; Population Groups
• Other Study ID Numbers: VV913-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No