VV261 tablet safety and dosing in healthy adults

A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics of a Single Oral Dose of VV261 Tablets in Chinese Healthy Volunteers

This trial will test single escalating doses of VV261 tablets in healthy adults to see if they are safe, tolerated, and how the drug is absorbed and cleared.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Vigonvita Life Sciences (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT07302269 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled single ascending-dose trial with an initial open-label pilot cohort to characterize safety, tolerability, and pharmacokinetics of oral VV261 tablets in healthy volunteers. After a 5 mg open-label pilot in two volunteers, seven double-blind dose cohorts of eight participants each will be randomized 6:2 to VV261 or placebo with planned doses from 20 mg to 1000 mg. The study plans to enroll up to 58 volunteers, with dose adjustments allowed based on observed safety and PK data, and includes intensive clinical monitoring and serial blood sampling. Primary outcomes are safety/tolerability measures and standard PK parameters following single oral administration.

Who should consider this trial

Good fit: Healthy adults 18–45 years old with BMI 19–26 kg/m2 (men ≥50 kg, women ≥45 kg) who agree to contraception and can follow study procedures are ideal candidates.

Not a fit: Individuals with hypersensitivity to the product or excipients, significant medical conditions, abnormal screening tests, pregnancy or breastfeeding, or those outside the specified age/weight/BMI ranges are unlikely to benefit from participation.

Why it matters

Potential benefit: If VV261 shows acceptable safety and predictable pharmacokinetics, the study could identify safe dose ranges and support later patient trials.

How similar studies have performed: Single ascending-dose Phase 1 trials of comparable oral investigational drugs commonly establish safety and PK profiles that enable later efficacy trials, but VV261 itself is novel and has limited human data beyond the pilot dosing.

Eligibility 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. Volunteers who are willing to take proper contraceptive methods during the study and within 3 months after the the last administration;
5. Volunteers who are able to understand and follow the study protocol and instructions; volunteers who have voluntarily decided to participate in this study, and sign the informed consent form.

Exclusion Criteria:

1. Volunteers with hypersensitivity to preparation or any of the excipients;
2. Volunteers with allergic constitution (such as asthma, urticaria, eczematous dermatitis and other allergic diseases), or have a history of drug or food allergy;
3. Volunteers 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;Volunteers 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. Volunteers 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. Volunteers 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. Volunteers 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. Volunteers who have participated in clinical trials and received drugs within 3 months before screening;
10. Volunteers who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 2 weeks before screening;
11. Volunteers 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. Volunteers 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. Volunteers 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);
14. Volunteers who smok more than 5 cigarettes a day within one year before screening;
15. Volunteers who can't quit smoking or drinking during the trial period;
16. Volunteers who are positive for hepatitis B virus surface antigen, hepatitis C virus antibody, treponema pallidum antibody or human immunodeficiency virus antibody (Anti-HIV);
17. Volunteers who cannot tolerate blood collection with intravenous indwelling needles or blood fainting;
18. Volunteers with lactose intolerance or cannot comply with a uniform diet (such as special dietary requirements, intolerance of standard meals, etc.), volunteers who have consumed excessive amounts of strong tea, coffee or caffeinated beverages in the 3 months before screening;
19. Volunteers with difficulty in swallowing tablets;
20. Pregnant or lactating women or male volunteers whose female partners plan to conceive within 3 months;
21. The investigator believes that there are other unsuitable factors to participate this trial.

Where this trial is running

Hefei, Anhui

• 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

Conditions Healthy Volunteers; VV261; Phase I; Tolerability; Pharmacokinetic; Safety