Clinical Trial

Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers

Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated October 3, 2025 (before its estimated March 19, 2026 completion). Its status may not reflect the trial's current state.
Summary
This Phase I study is a randomized, double-blind, placebo-controlled, dose-escalation trial conducted at a single center. It consists of two parts: Part 1 (SAD): Evaluates the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous doses of JKN2501 in healthy adults. Biological samples (blood, urine, feces) will be collected for PK analysis. Part 2 (MAD): Evaluates the safety, tolerability, and PK of multiple ascending intravenous doses of JKN2501 in healthy adults. Dose levels may be adjusted based on emerging safety, tolerability, and PK data from preceding cohorts.
Trial Details
NCT Number NCT07207291
Lead Sponsor Joincare Pharmaceutical Group Industry Co., Ltd
Conditions Bacterial Infections, Urinary Tract Infections, Intra-Abdominal Infections, Respiratory Tract Infections
Enrollment 66 participants
Start Date 2025-08-22
Primary Completion 2026-03-19 (estimated)
Study Completion 2026-03-19 (estimated)
Updated on ClinicalTrials.gov 2025-10-03