Safety and Pharmacokinetics of VV261 Tablets in Healthy Adults
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics of a Multiple Oral Dose of VV261 Tablets in Chinese Healthy Participants.
Run by Vigonvita Life Sciences · NCT07710326 · Data updated 2026-11-12
This study tests how VV261 tablets behave and how safe they are in healthy adults, using a random, placebo-controlled design with escalating doses.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 16 (estimated) |
| Sponsor | Vigonvita Life Sciences Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hefei, Anhui) |
| Status | Recruiting |
| Started | August 9, 2026 |
| Main results expected | November 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07710326 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18-45 with suitable weight and BMI, consenting to a reliable contraceptive method during and after the study.
✕Probably not a fit
Participants without any adverse safety signals at follow-up or those unlikely to benefit from VV261’s effects in a disease setting may not gain direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1, randomized, double-blind, placebo-controlled trial enrolling 16 healthy adults to assess the safety, tolerability, and pharmacokinetics of VV261 at two ascending oral doses (600 mg and 900 mg) given three times daily for 7.5 days plus a final morning dose. Participants are assigned to VV261 or placebo in two sequential dose groups to evaluate dose-related effects. Safety assessments include vital signs, labs, ECG, and imaging as indicated. The study aims to determine how the drug is processed in the body and to identify any dose-related adverse effects. Conducted at The First Affiliated Hospital of Anhui Medical University under lead sponsor Vigonvita Life Sciences.
Why it matters
Potential benefit: If successful, the data may support further development of VV261 by identifying a safe dosing range and understanding its pharmacokinetic profile.
How similar studies have gone: Phase 1 studies of similar compounds sometimes show favorable safety and pharmacokinetics, but results for VV261 are specific to this investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Aged 18 to 45 years old, males or females; 2. 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; 3. 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; 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);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) 4. 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.); 5. Participants with a history of spleen diseases; 6. 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; 7. If any of the following parameters were considered abnormal with clinical significance: total bilirubin, alkaline phosphatase, alanine aminotransferase, and aspartate aminotransferase; 8. 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); 9. Participants who have participated in clinical trials and received drugs within 3 months before screening; 10. Participants who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 2 weeks before screening; 11. 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; 12. 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); 13. 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; 14. Participants who smok more than 5 cigarettes a day within one year before screening; 15. Participants who can't quit smoking or drinking during the trial period; 16. Participants who are positive for hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody (Anti-HIV); 17. Participants who cannot tolerate blood collection with intravenous indwelling needles or blood fainting; 18. 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; 19. Participants with difficulty in swallowing tablets; 20. 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; 21. The investigator believes that there are other unsuitable factors to participate this trial.
Where it's running
-
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China Recruiting
Study contacts
- Principal investigator: Huan Zhou — The First Affiliated Hospital of Anhui Medical University
- Study coordinator: Huaqing Duan
- Email: huaqing.duan@vigonvita.cn
- Phone: 18061926005
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.