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Safety and Pharmacokinetics Study of Multiple Ascending Doses and Food Effect of LV232 Capsules

NCT06279533 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-11-24

No results posted yet for this study

Summary

This study is divided into two parts: the safety, tolerability, pharmacokinetic profiles of LV232 capsules after multiple ascending doses (hereinafter referred to as "PK characteristics of multiple ascending doses study ") and food effect study (hereinafter referred to as "FE study"). A total of 48 subjects are planned to be enrolled. The two parts of the study can be carried out simultaneously, and there is no order requirement.

Conditions

  • Healthy Subjects

Interventions

DRUG

LV232/Placebo

Drug: LV232 15mg Group: 6 subjects will receive LV232 15mg, orally; Other Names:Placebo 2 subjects will receive placebo, orally. Drug: LV232 40mg Group: 6 subjects will receive LV232 40mg, orally; Other Names:Placebo 2 subjects will receive placebo, orally. Drug: LV232 60mg Group: 6 subjects will receive LV232 60mg, orally; Other Names:Placebo 2 subjects will receive placebo, orally.

DRUG

LV232

Drug: LV232 20mg Group: 12 subjects will receive LV232 20mg, orally Drug: LV232 60mg Group: 12 subjects will receive LV232 60mg, orally

Sponsors & Collaborators

  • Vigonvita Life Sciences

    lead INDUSTRY

Principal Investigators

  • Chen Yu · Shanghai Xuhui Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-27
Primary Completion
2024-12-17
Completion
2024-12-17

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06279533 on ClinicalTrials.gov