Healthy VolunteersPhase 1NCT07710326
Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV261 Tablets
A Phase 1 study testing VV261 600mg TID group and VV261 900mg TID 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, multiple ascending-dose study to evaluate the safety, tolerability and pharmacokinetics characteristics of VV261 tablets in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- VV261 600mg TID group and VV261 900mg TID group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 30 Nov 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 to 26 kg/m^2;
- Vital signs examination, physical examination, laboratory examination ,electrocardiogram examination chest CT and B-ultrasound of liver, gallbladder, pancreas, spleen, kidney and thyroid results 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 previous surgery that may significantly affect the body's metabolic process or safety evaluation of the study drug (such as liver, gallbladder, kidney, splenectomy, gastrointestinal resection or excessive blood loss that affects drug absorption, distribution, metabolism)
- Participants with a history of diseases affecting bone marrow hematopoietic function or reducing immunological function (including leukemia, myelodysplastic syndrome, aplastic anemia, systemic lupus erythematosus, rheumatoid arthritis, etc.) or treatment history (tumor chemotherapy or radiotherapy, use of immunosuppressants, etc.);
- Participants with a history of spleen diseases;
- If any of the following parameters were considered abnormal with clinical significance: white blood cell count, red blood cell count, platelet count, reticulocyte count, and absolute neutrophil count;
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- If any of the following parameters were considered abnormal with clinical significance: total bilirubin, alkaline phosphatase, alanine aminotransferase, and aspartate aminotransferase;
- Participants who have received blood transfusion or used blood products within 3 months before screening or who have lost more than ≥400 mL of blood due to other reasons (excluding menstruation);
- Participants who have participated in clinical trials and received drugs within 3 months before screening;
- Participants who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 2 weeks before screening;
- Participants who have received vaccination within the first 2 weeks 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 white wine with 40% alcohol content or 85 mL of red wine with 12% alcohol) or participants with breath alcohol test >0 mg/100 mL;
- Participants who smok 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);
- Participants who cannot tolerate blood collection with intravenous indwelling needles or blood fainting;
- Participants with lactose intolerance or cannot comply with a uniform diet (such as special dietary requirements, intolerance of standard meals, etc.), Participants who have consumed excessive amounts of strong tea, coffee or caffeinated beverages in the 3 months before screening;
- Participants with difficulty in swallowing tablets;
- Pregnant or lactating women; participants whose spouses or partners intend to become pregnant, plan sperm or oocyte donation within 3 months after the last dose, or decline to use acceptable effective contraception；
- 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
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230031
About this study
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics of a Multiple Oral Dose of VV261 Tablets in Chinese Healthy Participants.
This is a randomized, double-blind, placebo-controlled, multiple ascending-dose study to evaluate the safety, tolerability and pharmacokinetics characteristics of VV261 tablets in healthy adults.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled trial designed to enroll a total of 16 participants. It initially comprises two dose groups administered sequentially from the low-dose group to the high-dose group, with eight participants in each group randomly assigned to either the investigational drug or placebo. The dose escalation levels were set at 600 mg and 900 mg, administered three times daily (with an 8-hour interval) for 7.5 consecutive days, followed by a final dose on the morning of day 8, totaling 22 doses.
- Conditions
- Healthy Volunteers
- Being tested
- VV261 600mg TID group, VV261 900mg TID group
- Keywords
- VV261, Phase I, Tolerability, Pharmacokinetic, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VV261 600mg TID groupDrug
6 participants receive VV261 100mg 6 tablets,three times daily,orally; 2 participants will receive placebo,orally
VV261 900mg TID groupDrug
6 participants receive VV261 100mg 9 tablets,three times daily,orally; 2 participants will receive placebo,orally
| Study group | Role | What they receive |
|---|---|---|
| VV261 | Experimental | Not described Receives: Drug: VV261 600mg TID group; Drug: VV261 900mg TID group |
| Placebo | Placebo comparator | Not described Receives: Drug: VV261 600mg TID group; Drug: VV261 900mg TID group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum observed plasma concentration
Measured: Baseline to 72 hours after the last administration
Tmax
Time at which Cmax occurs
Measured: Baseline to 72 hours after the last administration
Ctrough
Minimum observed steady-state plasma concentration
Measured: Baseline to 72 hours after the last administration
AUC0-t
Area under the plasma concentration time curve from time zero to the last measurable concentration
Measured: Baseline to 72 hours after the last administration
AUC0-∞
Area under the plasma concentration-time curve from time zero to infinity
Measured: Baseline to 72 hours after the last administration
t1/2
Half life of elimination
Measured: Baseline to 72 hours after the last administration
CL/F
Apparent clearance
Measured: Baseline to 72 hours after the last administration
mean Resident Time
Mean Resident Time from time zero to infinity/the last
Measured: Baseline to 72 hours after the last administration
Vd/F
Apparent volume of distribution during the terminal phase
Measured: Baseline to 72 hours after the last administration
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Measured: Baseline to 7days after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 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
- 16 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
- NCT07710326
- Sponsor's protocol ID
- VV261-02
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 17 Jul 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 Multiple Oral Dose of VV261 Tablets in Chinese Healthy Participants.
- ClinicalTrials.gov ID
- NCT07710326
- Acronym / sponsor ID
- VV261-02
- Conditions
- Healthy Volunteers
- Keywords
- VV261, Phase I, Tolerability, Pharmacokinetic, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Vigonvita Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 17 Jul 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, multiple ascending-dose study to evaluate the safety, tolerability and pharmacokinetics characteristics of VV261 tablets in healthy adults.
Detailed description
This study is a randomized, double-blind, placebo-controlled trial designed to enroll a total of 16 participants. It initially comprises two dose groups administered sequentially from the low-dose group to the high-dose group, with eight participants in each group randomly assigned to either the investigational drug or placebo. The dose escalation levels were set at 600 mg and 900 mg, administered three times daily (with an 8-hour interval) for 7.5 consecutive days, followed by a final dose on the morning of day 8, totaling 22 doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VV261 | Experimental | Drug: VV261 600mg TID group, Drug: VV261 900mg TID group |
| Placebo | Placebo comparator | Drug: VV261 600mg TID group, Drug: VV261 900mg TID group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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 to 26 kg/m^2;
- Vital signs examination, physical examination, laboratory examination ,electrocardiogram examination chest CT and B-ultrasound of liver, gallbladder, pancreas, spleen, kidney and thyroid results 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 (21 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 previous surgery that may significantly affect the body's metabolic process or safety evaluation of the study drug (such as liver, gallbladder, kidney, splenectomy, gastrointestinal resection or excessive blood loss that affects drug absorption, distribution, metabolism)
- Participants with a history of diseases affecting bone marrow hematopoietic function or reducing immunological function (including leukemia, myelodysplastic syndrome, aplastic anemia, systemic lupus erythematosus, rheumatoid arthritis, etc.) or treatment history (tumor chemotherapy or radiotherapy, use of immunosuppressants, etc.);
- Participants with a history of spleen diseases;
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 |
|---|---|---|
| VV261 600mg TID group6 participants receive VV261 100mg 6 tablets,three times daily,orally; 2 participants will receive placebo,orally | Drug | Placebo, VV261 |
| VV261 900mg TID group6 participants receive VV261 100mg 9 tablets,three times daily,orally; 2 participants will receive placebo,orally | Drug | Placebo, VV261 |
Primary outcome
Cmax
Time frame: Baseline to 72 hours after the last administration
Maximum observed plasma concentration
Tmax
Time frame: Baseline to 72 hours after the last administration
Time at which Cmax occurs
Ctrough
Time frame: Baseline to 72 hours after the last administration
Minimum observed steady-state plasma concentration
AUC0-t
Time frame: Baseline to 72 hours after the last administration
Area under the plasma concentration time curve from time zero to the last measurable concentration
AUC0-∞
Time frame: Baseline to 72 hours after the last administration
Area under the plasma concentration-time curve from time zero to infinity
t1/2
Time frame: Baseline to 72 hours after the last administration
Half life of elimination
CL/F
Time frame: Baseline to 72 hours after the last administration
Apparent clearance
mean Resident Time
Time frame: Baseline to 72 hours after the last administration
Mean Resident Time from time zero to infinity/the last
Vd/F
Time frame: Baseline to 72 hours after the last administration
Apparent volume of distribution during the terminal phase
Incidence of Treatment-Emergent Adverse Events
Time frame: Baseline to 7days after the last administration
Incidence of Treatment-Emergent 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 17 Jul 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 VV261 600mg TID group and VV261 900mg TID 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 21 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: opening soon, as of the sponsor's last update on 17 Jul 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: Baseline to 72 hours after the last 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 17 Jul 2026.