NCT05922709

A Clinical Trial of CS12192 in Healthy Subjects

A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic Profiles Following Single and Multiple Doses and Food Effect of CS12192 Capsules in Healthy Adult Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Chipscreen Biosciences, Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CS12192 after single or multiple oral administration, as well as the food effect on the pharmacokinetics in healthy subjects.

Detailed description

This study consists of 3 parts: single ascending dose (SAD), multiple ascending dose (MAD) and food effect (FE). Both SAD and MAD study are randomized, double-blind, placebo-controlled design. The FE study use a randomized, open-label, two-period, two-crossover design.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CS12192 capsule	Participants receive CS12192 orally single or multiple doses
DRUG	Placebo capsule	Participants receive placebo matching CS12192 orally single or multiple doses

Timeline

• Start date: 2023-07-20
• Primary completion: 2024-02-01
• Completion: 2024-02-01
• First posted: 2023-06-28
• Last updated: 2024-02-07

Locations

1 site across 1 country: China