NCT06224595

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic Profiles and Food Effect of CS32582 Capsules

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 CS32582 Capsules in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Chipscreen Biosciences, Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CS32582 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), food effect (FE) and multiple ascending dose (MAD). Both SAD and MAD study are randomized, double-blind, placebo-controlled design. The FE study is a randomized, open-label, two-period, two-crossover design.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CS32582 capsule	Participants receive CS32582 orally single or multiple doses
DRUG	Placebo capsule	Participants receive placebo matching CS32582 orally single or multiple doses

Timeline

• Start date: 2024-03-28
• Primary completion: 2024-11-27
• Completion: 2024-11-27
• First posted: 2024-01-25
• Last updated: 2024-12-03

Locations

1 site across 1 country: China