Study of the Safety, Tolerability, Pharmacokinetics of VV261 Tablets in Chinese Healthy Volunteers

NCT07302269 | Recruiting Phase 1

• 1 other identifier: VV261-01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, placebo-controlled, single 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

  48 hours after administration]

• AUC0-t

  area under the plasma concentration time curve from time zero to the last measurable concentration

  48 hours after administration

• AUC0-∞

  area under the plasma concentration-time curve from time zero to infinity

  48 hours after administration]

• Tmax

  time at which Cmax occurs

  48 hours after administration

• t1/2

  half life of elimination

  48 hours after administration

• Kel

  elimination rate constant

  48 hours after administration

• CLz/F

  apparent clearance

  48 hours after administration

• Vd/F

  apparent volume of distribution during the terminal phase

  48 hours after administration

• MRT

  mean residence time

  48 hours after administration

• AE & SAE

  Adverse event \& serious adverse events

  from day1 to day7 after administration

Study Arms (2)

VV261

EXPERIMENTAL

Drug: VV261 5mg group; Drug: VV261 20mg Group; Drug: VV261 50mg group; Drug: VV261 100mg group; Drug: VV261 150mg group; Drug: VV261 300mg group; Drug: VV261 500mg group; Drug: VV261 750mg group; Drug: VV261 1000mg group

Placebo

PLACEBO COMPARATOR

Drug: VV261 20mg Group; Drug: VV261 50mg group; Drug: VV261 100mg group; Drug: VV261 150mg group; Drug: VV261 300mg group; Drug: VV261 500mg group; Drug: VV261 750mg group; Drug: VV261 1000mg group

Interventions

VV261 5mg group DRUG

2 subjects will receive VV261 5mg, orally

VV261

VV261 20mg Group DRUG

6 subjects receive VV261 20mg,orally; 2 subjects will receive placebo,orally.

Placebo; VV261

VV261 50mg group DRUG

6 subjects receive VV261 50mg,orally; 2 subjects will receive placebo,orally.

Placebo; VV261

VV261 100mg group DRUG

6 subjects receive VV261 100mg,orally; 2 subjects will receive placebo,orally.

Placebo; VV261

VV261 150mg group DRUG

6 subjects receive VV261 150mg,orally; 2 subjects will receive placebo,orally.

Placebo; VV261

VV261 300mg group DRUG

6 subjects receive VV261 300mg,orally; 2 subjects will receive placebo,orally.

Placebo; VV261

VV261 500mg group DRUG

6 subjects receive VV261 500mg,orally; 2 subjects will receive placebo,orally.

Placebo; VV261

VV261 750mg group DRUG

6 subjects receive VV261 750mg,orally; 2 subjects will receive placebo,orally.

Placebo; VV261

VV261 1000mg group DRUG

6 subjects receive VV261 1000mg,orally; 2 subjects 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;
• Volunteers who are willing to take proper contraceptive methods during the study and within 3 months after the the last administration;
• 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.

You may not qualify if:

• Volunteers with hypersensitivity to preparation or any of the excipients;
• Volunteers with allergic constitution (such as asthma, urticaria, eczematous dermatitis and other allergic diseases), or have a history of drug or food allergy;
• 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);
• 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.);
• Volunteers 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;
• 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);
• Volunteers who have participated in clinical trials and received drugs within 3 months before screening;
• Volunteers who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines or health products within 2 weeks before screening;
• 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;
• 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);
• 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);
• Volunteers who smok more than 5 cigarettes a day within one year before screening;
• Volunteers 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

RECRUITING

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

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: December 11, 2025
• First Posted: December 24, 2025
• Study Start: January 4, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 3, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)