Healthy VolunteersPhase 1NCT07372703
Study of the Safety, Tolerability, Pharmacokinetics of VV913 Capsules in Chinese Healthy Participants
A Phase 1 study testing VV913 1mg group, VV913 2mg group and VV913 4mg group in people with Healthy Volunteers, run by Vigonvita Life Sciences at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- VV913 1mg group, VV913 2mg group and VV913 4mg group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 29 Jan 2026to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 ,electrocardiogram examination chest CT 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.
Who cannot join
- 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;
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- 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;
- Participants who cannot tolerate blood collection with intravenous indwelling needles or blood fainting;
- Participants with difficulty in swallowing capsules;
- Participants whose female partners plan to conceive within 3 months;
- The investigator believes that there are other unsuitable factors to participate this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230031
Huan Zhou, 13665527160, zhouhuanbest@vip.163.com
About this study
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics of a Single Oral Dose of VV913 Capsules in Chinese Healthy Participants
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.
Read the detailed description
The study is designed to enroll 56 participants. The study , conducted as a double-blind study, comprise 7 dose groups with 8 participants each. Participants will be randomly assigned to receive either the VV913 Capsules or placebo in a ratio of 6:2. Dose groups are designed as 1 mg, 2 mg, 4 mg, 8 mg, 15 mg, 25 mg, and 40 mg. Based on observed tolerability and safety data or obtained pharmacokinetic data, adjustments are allowed at all dose levels in the clinical trial.
- Conditions
- Healthy Volunteers
- Being tested
- VV913 1mg group, VV913 2mg group, VV913 4mg group, VV913 8mg group, VV913 15mg group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VV913 1mg groupDrug
6 participants will receive VV913 1mg orally; 2 participants will receive placebo orally.
VV913 2mg groupDrug
6 participants will receive VV913 2mg orally; 2 participants will receive placebo orally.
VV913 4mg groupDrug
6 participants will receive VV913 4mg orally; 2 participants will receive placebo orally.
VV913 8mg groupDrug
6 participants will receive VV913 8mg orally; 2 participants will receive placebo orally.
VV913 15mg groupDrug
6 participants will receive VV913 15mg orally; 2 participants will receive placebo orally.
VV913 25mg groupDrug
6 participants will receive VV913 25mg orally; 2 participants will receive placebo orally.
VV913 40mg groupDrug
6 participants will receive VV913 40mg orally; 2 participants will receive placebo orally.
| Study group | Role | What they receive |
|---|---|---|
| VV913 | Experimental | Not described Receives: Drug: VV913 1mg group; Drug: VV913 2mg group; Drug: VV913 4mg group; Drug: VV913 8mg group; Drug: VV913 15mg group; Drug: VV913 25mg group; Drug: VV913 40mg group |
| Placebo | Placebo comparator | Not described Receives: Drug: VV913 1mg group; Drug: VV913 2mg group; Drug: VV913 4mg group; Drug: VV913 8mg group; Drug: VV913 15mg group; Drug: VV913 25mg group; Drug: VV913 40mg group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
maximum observed plasma concentration
Measured: 72 hours after administration
Tmax
time at which Cmax occurs
Measured: 72 hours after administration
t1/2
half life of elimination
Measured: 72 hours after administration
AUC0-t
area under the plasma concentration time curve from time zero to the last measurable concentration
Measured: 72 hours after administration
AUC0-∞
area under the plasma concentration-time curve from time zero to infinity
Measured: 72 hours after administration
Kel
elimination rate constant
Measured: 72 hours after administration
Vd/F
apparent volume of distribution during the terminal phase
Measured: 72 hours after administration
MRT
mean residence time
Measured: 72 hours after administration
CL/F
apparent clearance
Measured: 72 hours after administration
AE & SAE
Adverse event \& serious adverse events
Measured: from day1 to day7 after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start29 Jan 2026
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Vigonvita Life SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vigonvita Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Huan Zhou, Principal investigator, The First Affiliated Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372703
- Sponsor's protocol ID
- VV913-01
- Status last verified
- Apr 2026
- First submitted
- 19 Jan 2026
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics of a Single Oral Dose of VV913 Capsules in Chinese Healthy Participants
- ClinicalTrials.gov ID
- NCT07372703
- Acronym / sponsor ID
- VV913-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Vigonvita Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is designed to enroll 56 participants. The study , conducted as a double-blind study, comprise 7 dose groups with 8 participants each. Participants will be randomly assigned to receive either the VV913 Capsules or placebo in a ratio of 6:2. Dose groups are designed as 1 mg, 2 mg, 4 mg, 8 mg, 15 mg, 25 mg, and 40 mg. Based on observed tolerability and safety data or obtained pharmacokinetic data, adjustments are allowed at all dose levels in the clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VV913 | Experimental | Drug: VV913 1mg group, Drug: VV913 2mg group, Drug: VV913 4mg group, Drug: VV913 8mg group, Drug: VV913 15mg group, Drug: VV913 25mg group, Drug: VV913 40mg group |
| Placebo | Placebo comparator | Drug: VV913 1mg group, Drug: VV913 2mg group, Drug: VV913 4mg group, Drug: VV913 8mg group, Drug: VV913 15mg group, Drug: VV913 25mg group, Drug: VV913 40mg group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 ,electrocardiogram examination chest CT 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.
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VV913 1mg group6 participants will receive VV913 1mg orally; 2 participants will receive placebo orally. | Drug | Placebo, VV913 |
| VV913 2mg group6 participants will receive VV913 2mg orally; 2 participants will receive placebo orally. | Drug | Placebo, VV913 |
| VV913 4mg group6 participants will receive VV913 4mg orally; 2 participants will receive placebo orally. | Drug | Placebo, VV913 |
| VV913 8mg group6 participants will receive VV913 8mg orally; 2 participants will receive placebo orally. | Drug | Placebo, VV913 |
| VV913 15mg group6 participants will receive VV913 15mg orally; 2 participants will receive placebo orally. | Drug | Placebo, VV913 |
| VV913 25mg group6 participants will receive VV913 25mg orally; 2 participants will receive placebo orally. | Drug | Placebo, VV913 |
| VV913 40mg group6 participants will receive VV913 40mg orally; 2 participants will receive placebo orally. | Drug | Placebo, VV913 |
Primary outcome
Cmax
Time frame: 72 hours after administration
maximum observed plasma concentration
Tmax
Time frame: 72 hours after administration
time at which Cmax occurs
t1/2
Time frame: 72 hours after administration
half life of elimination
AUC0-t
Time frame: 72 hours after administration
area under the plasma concentration time curve from time zero to the last measurable concentration
AUC0-∞
Time frame: 72 hours after administration
area under the plasma concentration-time curve from time zero to infinity
Kel
Time frame: 72 hours after administration
elimination rate constant
Vd/F
Time frame: 72 hours after administration
apparent volume of distribution during the terminal phase
MRT
Time frame: 72 hours after administration
mean residence time
CL/F
Time frame: 72 hours after administration
apparent clearance
AE & SAE
Time frame: from day1 to day7 after administration
Adverse event \& serious adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huan Zhou principal investigator
The First Affiliated Hospital of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VV913 1mg group, VV913 2mg group and VV913 4mg group in people with Healthy Volunteers, run by Vigonvita Life Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huaqing Duan (18061926005, huaqing.duan@vigonvita.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: 72 hours after administration). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.