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.
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…
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