Safety and Pharmacokinetics Study of Multiple Ascending Doses of VV116 in Healthy Volunteers

NCT ID: NCT05201690

Last Updated: 2022-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-14
• Study Completion Date: 2022-01-23

Brief Summary

This is a randomized, double-blinded, placebo-controlled, single-center phase I clinical trial. The objective of this study is to evaluate the safety, tolerability, pharmacokinetic profiles of VV116 tablets after multiple ascending doses administered orally to Chinese healthy volunteers.

Detailed Description

Multiple-dose ascending design is used in the trial, VV116/Placebo is administered sequentially from low-dose to high-dose and each subject can only orally receive one dose level. There are 3 dose groups (200mg, 400mg, 600mg), investigational product is orally administrated BID for 5.5 days, the last dose is taken in D6 morning. When 7th day visit after last dose (D12) is completed for previous dose group, investigator and sponsor will evaluate the safety and determine whether the next dose group can be started. 12 subjects will be enrolled in each dose group and the ratio of investigational product to placebo is 3:1.

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

VV116 200 mg Group

VV116 200 mg Group

Group Type: EXPERIMENTAL

VV116 200 mg Group

Intervention Type: DRUG

Drug: VV116 9 subjects will receive VV116 200 mg, orally, QD12h, 5.5 days ;

VV116 400 mg Group

VV116 400 mg Group

Group Type: EXPERIMENTAL

VV116 400mg Group

Intervention Type: DRUG

Drug: VV116 9 subjects will receive VV116 400 mg, orally, QD12h, 5.5 days ;

VV116 600 mg Group

VV116 600 mg Group

Group Type: EXPERIMENTAL

VV116 600mg Group

Intervention Type: DRUG

Drug: VV116 9 subjects will receive VV116 600 mg, orally, QD12h, 5.5 days ;

Placebo

VV116 Matching placebo tablets; Multiple doses

Group Type: PLACEBO_COMPARATOR

VV116 200 mg Group

Intervention Type: DRUG

Drug: VV116 9 subjects will receive VV116 200 mg, orally, QD12h, 5.5 days ;

VV116 400mg Group

Intervention Type: DRUG

Drug: VV116 9 subjects will receive VV116 400 mg, orally, QD12h, 5.5 days ;

VV116 600mg Group

Intervention Type: DRUG

Drug: VV116 9 subjects will receive VV116 600 mg, orally, QD12h, 5.5 days ;

Interventions

VV116 200 mg Group

Drug: VV116 9 subjects will receive VV116 200 mg, orally, QD12h, 5.5 days ;

Intervention Type: DRUG

VV116 400mg Group

Drug: VV116 9 subjects will receive VV116 400 mg, orally, QD12h, 5.5 days ;

Intervention Type: DRUG

VV116 600mg Group

Drug: VV116 9 subjects will receive VV116 600 mg, orally, QD12h, 5.5 days ;

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy subjects between the ages of 18 and 45 years;

2. Body weight no less than 50 kg for male, no less than 45 kg for female; Body Mass Index of 19 to 26kg/m2;

3. Physical examination, vital signs examination, laboratory examination, ECG, B-ultrasound and fundus examination results were normal or abnormal without clinical significant;

4. Subjects who are willing to take proper contraceptive during the study and within 3 months after the study completed;

5. Subjects who are able to understand and follow study plans and instructions; Subjects who have voluntarily decided to participate in this study, and signed the informed consent form;

Exclusion Criteria

1. Subjects with hypersensitivity to VV116 or any of the excipients;

2. Subjects with allergic diseases or allergic constitution;

3. Subjects with central nervous system,cardiovascular system,gastrointestinal, respiratory system,urinary,Hematologic System,metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials;

4. Blood donation or blood loss ≥ 400 mL within 3 months prior to inclusion, or have a history of blood product use history;

5. Participated in a clinical study involving another investigational drug within 3 month before the screening visit;

6. Taken any prescription drugs, non-prescription drugs, Chinese herbal medicine or health care products within 2 weeks prior to screening;

7. Drug or alcohol addicts within 1 year prior to screening, who drink at least twice a day or more than 14 units per week, or who are addicted to alcohol (1 unit ≈200 mL beer with 5% alcohol content, 25 mL spirits with 40% alcohol content or 85 mL wine with 12% alcohol content) ;

8. Those who smoke more than 10 cigarettes per day and do not agree to avoid using any tobacco products during the trial period;

9. Those who cannot quit smoking or drinking during the trial;

10. Those who are positive for hepatitis B surface antigen (HBsAg), HCV antibody, syphilis antibody and HIV antibody;

11. Abnormal and clinically significant chest radiographs (anteroposterior);

12. B ultrasound examination showed moderate to severe fatty liver;

13. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeded the upper normal limit (ULN) at screening time or baseline;

14. Glomerular filtration rate (eGFR) < 90 mL/min/1.73m2 at screening time or baseline;

15. Abnormal ecg at screening or baseline, single QTcF (corrected for heart rate) > 450 ms in men, > 470 ms in women, and/or other clinically significant abnormalities;

16. Pregnant or lactating women or male subjects whose spouse has a child care plan within 3 months;

17. The investigator believes that there are other factors that are not suitable for participating in this trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vigonvita Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gangyi Liu

Role: PRINCIPAL_INVESTIGATOR

Shanghai Xuhui Central Hospital

Locations

Shanghai Xuhui Central Hospital

Shanghai, , China

Countries

China

Other Identifiers

VV116-02

Identifier Type: -

Identifier Source: org_study_id