NCT06070857

Study of the Safety, Tolerability, and Pharmacokinetics of LV232 Capsules in Chinese Healthy Volunteers

A Randomized, Double-blind, Placebo-Controlled, Single-Centre,Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of LV232 Capsules in Chinese Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Vigonvita Life Sciences · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study consists of 10 dose groups, 8 subjects in each group (male or female), randomly assigned to study drug or placebo group to evaluate the safety, tolerability and pharmacokinetics characteristics.

Detailed description

The dose levels are planned at 1 mg, 2 mg, 4 mg, 8 mg, 15 mg, 25 mg,40 mg, 60 mg ,90 mg and 120mg. 6 subjects in each group will receive LV232 tablets and 2 subjects will receive placebo. The subject number of single dose group may increase or decrease depending on the safety and PK data obtained.1 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.).Based on observed tolerability and safety data or obtained PK data, adjustments are allowed at all dose levels in the clinical trial.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	LV232	Drug: LV232 1mg,2mg,4mg,8mg,15mg,25mg,40mg,60mg,90mg and 120mg
DRUG	Placebo	Placebo:1mg,2mg,4mg,8mg,15mg,25mg,40mg,60mg,90mg and 120mg

Timeline

• Start date: 2023-10-05
• Primary completion: 2025-11-17
• Completion: 2025-11-17
• First posted: 2023-10-06
• Last updated: 2025-12-16

Locations

1 site across 1 country: China