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

NCT07618156 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2026-06-01

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers (HV)

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.

Sponsors & Collaborators

  • Jiangxi Kvvit Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Guoping Yang · The Third Xiangya Hospital, Central South University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2026-12-31
Completion
2027-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07618156 on ClinicalTrials.gov