Status:
RECRUITING
Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers
Lead Sponsor:
Joincare Pharmaceutical Group Industry Co., Ltd
Conditions:
Bacterial Infections
Urinary Tract Infections
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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, a...
Eligibility Criteria
Inclusion
- 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, laboratory tests, chest X-ray, and abdominal ultrasound results judged as normal or clinically insignificant by the investigator.
- Agreement to use effective non-pharmaceutical contraception from signing ICF until 90 days after last dose; no sperm/egg donation plans during this period.
Exclusion
- Pregnant/lactating women; positive pregnancy test; unprotected sex within 2 weeks prior to dosing.
- Investigator-determined history or presence of clinically significant disorder that may affect safety or trial participation.
- Use of drugs known to inhibit/induce hepatic metabolism within 4 weeks, or any medication (prescription, OTC, herbal, vitamins) within 2 weeks prior to dosing; planned use during the trial.
- Major surgery within 3 months prior to screening or planned during trial; history of surgery potentially affecting results.
- History of febrile illness or active infection within 2 weeks prior to screening.
- Blood loss/donation \>400 mL within 3 months prior to screening, or received blood products; plans to donate blood during trial or within 30 days after last dose.
- History of significant food/drug allergy, or allergy to JKN2501/excipients.
- Excessive alcohol consumption; inability to abstain from alcohol from 48h pre-dose until end of study.
- Smoking ≥5 cigarettes/day within 3 months prior to screening; inability to abstain from smoking from 48h pre-dose until end of study.
- History of drug abuse; positive urine drug screen at baseline (Day -1).
- Positive alcohol breath test at baseline (Day -1).
- Participation in another interventional clinical trial within 3 months prior to screening or planned during this trial.
- Estimated glomerular filtration rate (eGFR) \<90 mL/min.
- Serum total calcium below lower limit of normal at screening.
- Investigator-determined unsuitable venous access for PK sampling/infusion, or history of adverse symptoms/phobias related to infusion/phlebotomy.
- Excessive daily intake of tea, coffee, or caffeinated beverages within 3 months prior to screening.
- Consumption of grapefruit, Seville oranges, caffeine, or xanthine-rich foods/beverages within 48h prior to first dose; inability to abstain during the trial.
- History of QTc prolongation; or investigator-determined clinically significant ECG abnormalities at screening/baseline.
- Any other condition deemed by the investigator to make the subject unsuitable for participation.
Key Trial Info
Start Date :
August 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 19 2026
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT07207291
Start Date
August 22 2025
End Date
March 19 2026
Last Update
October 3 2025
Active Locations (1)
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1
The Third hospital of Changsha
Changsha, Hunan, China, 410035