Testing single and multiple IV doses of JKN2501 in healthy Chinese adults

A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers

This test gives single and multiple intravenous doses of JKN2501 to healthy Chinese adults to see if it's safe and how the body processes it.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Joincare Pharmaceutical Group Industry Co., Ltd (Industry-sponsored)
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT07207291 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled, single-center Phase I trial uses single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts to study safety, tolerability, and pharmacokinetics of intravenous JKN2501 in healthy volunteers. Participants are randomly assigned to receive JKN2501 or placebo while biological samples (blood, urine, feces) are collected for PK analysis. Dose levels may be adjusted across cohorts based on emerging safety, tolerability, and PK data, with close monitoring of vital signs, labs, ECGs, and adverse events. The study enrolls adults 18–45 who meet strict inclusion/exclusion criteria and requires attendance at The Third Hospital of Changsha for dosing and follow-up.

Who should consider this trial

Good fit: Healthy adults aged 18–45 in China who meet the BMI and weight requirements, are not pregnant or breastfeeding, and agree to contraception and study procedures are the intended participants.

Not a fit: People with active infections, significant medical conditions, pregnant or breastfeeding women, those taking certain medications recently, or those unable to comply with confinement and follow-up are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could support later trials that may lead to a new intravenous antibiotic option for bacterial infections such as urinary, intra‑abdominal, and respiratory infections.

How similar studies have performed: SAD/MAD dose‑escalation studies are standard for early antibiotic development and many candidates have advanced after favorable Phase I safety and PK data, but JKN2501 itself remains at an early, unproven stage.

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, 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 Criteria:

* 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.

Where this trial is running

Changsha, Hunan

• The Third hospital of Changsha — Changsha, Hunan, China (Recruiting)

Study contacts

• Study coordinator: Yin Yang

Conditions Bacterial Infections; Urinary Tract Infections; Intra-Abdominal Infections; Respiratory Tract Infections