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

Recruiting Phase 1 Interventional Study
Bacterial Infections Urinary Tract Infections Intra-Abdominal Infections Respiratory Tract Infections
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 45
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
66 (estimated)
Sponsor
Joincare Pharmaceutical Group Industry Co., Ltd · Industry
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About This Trial
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 sa…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Voluntary informed consent; able to comply with study requirements and communicate effectively. * Healthy subjects aged 18-45 years (inclusive) at screening. * BMI 19.0-26.0 kg/m² (inclusive); weight ≥50 kg (male) or ≥45 kg (female). * Vital signs, physical examination, ECG, l…
Contacts

Yin Yang

+86-0755-33268688

overseas@joincare.com

CONTACT