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NOT YET RECRUITING
NCT07618156
PHASE1

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

Sponsor: Jiangxi Kvvit Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of Single and Multiple Ascending Intravenous Doses of KR25102 for Injection in Healthy Adult Chinese Participants

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

83

Start Date

2026-06

Completion Date

2027-03

Last Updated

2026-06-01

Healthy Volunteers

Yes

Interventions

DRUG

KR25102 for Injection

Intravenous injection of KR25102 for Injection at different dose levels in SAD and MAD cohorts.

DRUG

Placebo for KR25102 for Injection

Intravenous injection of matching placebo.

Locations (1)

The Third Xiangya Hospital, Central South University

Changsha, Hunan, China