NCT05227768

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

A Dose-escalation, Single-center, Randomized, Double-blinded, Placebo-controlled, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profiles of VV116 Administered Orally to Chinese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Vigonvita Life Sciences · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study consists of 5 dose groups, starting at 25 mg, 6 subjects in 25 mg group, and 8 subjects in each other group (male or female), randomly assigned to study drug or placebo group to evaluate the safety, tolerability and PK characteristics. The subject number of single dose group may increase or decrease depending on the safety and PK data obtained. The dose levels are planned at 25 mg, 200 mg, 400 mg, 800 mg and 1200 mg. Based on observed tolerability and safety data or obtained PK data, adjustments are allowed at all dose levels in the clinical trial.

Detailed description

4 subjects in the 25 mg dose group will receive VV116 tablets and the other 2 subjects will receive placebo. In other dose groups, 6 subjects in each group will receive VV116 tablets and 2 subjects will receive placebo. 25mg,800mg and 1200 mg dose group will be given by sentinel administration (i.e. 1 study drug, 1 placebo). Subjects who receive sentinel administration will be observed for 48 hours and investigator will evaluate the safety parameters (including symptoms, vital signs, physical examination, etc.).

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	VV116 25mg Group	4 subjects will receive VV116 25mg,orally; 2 subjects will receive placebo,orally.
DRUG	VV116 200mg Group	6 subjects will receive VV116 200mg,orally; 2 subjects will receive placebo,orally.
DRUG	VV116 400mg Group	6 subjects will receive VV116 400mg,orally; 2 subjects will receive placebo,orally.
DRUG	VV116 800mg Group	6 subjects will receive VV116 800mg,orally; 2 subjects will receive placebo,orally.
DRUG	VV116 1200mg Group	6 subjects will receive VV116 1200mg,orally; 2 subjects will receive placebo,orally.

Timeline

• Start date: 2021-11-11
• Primary completion: 2022-01-13
• Completion: 2022-01-13
• First posted: 2022-02-07
• Last updated: 2022-06-01

Locations

1 site across 1 country: China