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drugset / Trial / NCT06365580

Dose Escalation Study of Kylo-0603 in Healthy Subjects

NCT06365580 ↗

Phase 1 Completed 132 enrolled Kylonova (Xiamen) Biopharma co., LTD.
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2023-05-23
Primary completion
2024-08-16
Completion
2024-08-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Kylo-0603 Unknown 0.3 mg Oral
Subject Kylo-0603 Unknown 0.6 mg Oral
Subject Kylo-0603 Unknown 1.2 mg Oral
Subject Kylo-0603 Unknown 2 mg Oral
Subject Kylo-0603 Unknown 2.4 mg Oral
Subject Kylo-0603 Unknown 4 mg Oral
Subject Kylo-0603 Unknown 4.6 mg Oral
Subject Kylo-0603 Unknown 8 mg Oral
Subject Kylo-0603 Unknown 8.6 mg Oral
Subject Kylo-0603 Unknown 12 mg Oral
Subject Kylo-0603 Unknown 16 mg Oral
Subject Kylo-0603 Unknown 20 mg Oral

Indications

metabolic dysfunction-associated steatohepatitis