NCT06365580

Dose Escalation Study of Kylo-0603 in Healthy Subjects

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Ascending Doses of Kylo-0603 Capsules in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Kylonova (Xiamen) Biopharma co., LTD. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This clinical trial is the first-in-human study of Kylo-0603. The purpose of this randomized, double-blind, placebo-controlled phase 1 study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and effect of food of Kylo-0603 in healthy Chinese adult subjects.

Detailed description

The study consists of three parts: single ascending doses (Part 1), food effect (Part 2) and multiple ascending doses (Part 3).

Conditions

• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Kylo-0603 capsule	Administrated orally.
DRUG	Placebo	Administrated orally.

Timeline

• Start date: 2023-05-23
• Primary completion: 2024-08-16
• Completion: 2024-08-16
• First posted: 2024-04-15
• Last updated: 2024-10-09

Locations

1 site across 1 country: China