Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KR25102 in Healthy Volunteers

Phase 1 Not yet recruiting 83 enrolled Jiangxi Kvvit Pharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindBasic science

Summary

Phase 1 Single Ascending Doses(SAD): Six cohorts of 53 healthy volunteers (HVs) will receive a single IV bolus injection of study drug or placebo. Phase 1 Multiple Ascending Doses(MAD): Three cohorts of 30 HVs will receive multiple IV bolus injections of study drug or placebo every day. After 7 days of continuous administration, the safety, tolerance and Pharmacokinetic/Pharmacodynamic characteristics of multiple administrations were evaluated.

Timeline

Start: 2026-06
Primary completion: 2026-12
Completion: 2027-03

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	KR25102	Unknown	5 mg	Intravenous
Subject	KR25102	Unknown	10 mg	Intravenous
Subject	KR25102	Unknown	20 mg	Intravenous
Subject	KR25102	Unknown	30 mg	Intravenous
Subject	KR25102	Unknown	45 mg	Intravenous
Subject	KR25102	Unknown	60 mg	Intravenous

Indications

No indication recorded.