Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV261 Tablets

NCT07710326 | Not Yet Recruiting Phase 1

• 1 other identifier: VV261-02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

VV261; Phase I; Tolerability; Pharmacokinetic; Safety

Outcome Measures

Primary Outcomes (10)

• Cmax

  Maximum observed plasma concentration

  Baseline to 72 hours after the last administration

• Tmax

  Time at which Cmax occurs

  Baseline to 72 hours after the last administration

• Ctrough

  Minimum observed steady-state plasma concentration

  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

  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

• t1/2

  Half life of elimination

  Baseline to 72 hours after the last administration

• CL/F

  Apparent clearance

  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

• Vd/F

  Apparent volume of distribution during the terminal phase

  Baseline to 72 hours after the last administration

• Incidence of Treatment-Emergent Adverse Events

  Incidence of Treatment-Emergent Adverse Events

  Baseline to 7days after the last administration

Study Arms (2)

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

Interventions

VV261 600mg TID group DRUG

6 participants receive VV261 100mg 6 tablets,three times daily,orally; 2 participants will receive placebo,orally

Placebo; VV261

VV261 900mg TID group DRUG

6 participants receive VV261 100mg 9 tablets,three times daily,orally; 2 participants will receive placebo,orally

Placebo; VV261

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Vigonvita Life Sciences: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230031, China

Location

Study Officials

• Huan Zhou

  The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huaqing Duan

CONTACT

18061926005; huaqing.duan@vigonvita.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 17, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)