NCT05432713

A Study of LP-168 in Healthy Volunteers

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LP-168 Following Single and Multiple Oral Administration to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I study designed to assess the safety, tolerability and pharmacokinetics of LP-168 in healthy human volunteers.

Detailed description

This study will enroll 70 healthy subjects, will set 4 SAD and 3 MAD dose cohorts, with 10 subjects in each dose cohort. Subjects will be assigned to L-168 or placebo group by ratio of 8:2 in each cohort. Sentinel subjects will be used in each dose cohort during the single dose phase.

Conditions

• Multiple Sclerosis
• NMO Spectrum Disorder

Interventions

Type	Name	Description
DRUG	LP-168 tablet	Lp-168 is a small molecule kinase inhibitor that is administered once daily via oral administration
DRUG	LP-168 Placebo tablet	LP-168 placebo tablets contain excipients for LP-168 tablets, but do not contain the active ingredients of the drug, and are used for comparison in clinical trials with the same usage and dosage as LP-168 tablets

Timeline

• Start date: 2022-05-14
• Primary completion: 2022-11-20
• Completion: 2022-12-28
• First posted: 2022-06-27
• Last updated: 2023-02-24

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study