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RecruitingNCT07207291Updated Oct 3, 2025

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

A Phase 1 interventional study of JKN2501 and Placebo in Bacterial Infections, Urinary Tract Infections and Intra-Abdominal Infections, sponsored by Joincare Pharmaceutical Group Industry Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-03.

Sponsored by Joincare Pharmaceutical Group Industry Co., Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Aug 2025; still recruiting 1 year 1 month later.
Phase
Phase 1
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bacterial Infections
  • Urinary Tract Infections
  • Intra-Abdominal Infections
  • Respiratory Tract Infections

Keywords

  • Bacterial Infections
03

In context

Bacterial Infections

658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.

This study's planned enrollment of 66 is below the median of 84 across 405 interventional studies indexed under Bacterial Infections.

Browse Bacterial Infections studies →

Lead sponsor

Joincare Pharmaceutical Group Industry Co., Ltd is the lead sponsor of 9 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
66 participants (estimated)

Study arms

  • Experimental
    SAD Cohort1

    JKN2501 125mg only, without placebo.

    Drug: JKN2501

  • Experimental
    SAD Cohort2

    JKN2501 B mg

    Drug: JKN2501 · Drug: Placebo

  • Experimental
    SAD Cohort3

    JKN2501 C mg

    Drug: JKN2501 · Drug: Placebo

  • Experimental
    SAD Cohort4

    JKN2501 D mg

    Drug: JKN2501 · Drug: Placebo

  • Experimental
    SAD Cohort5

    JKN2501 E mg

    Drug: JKN2501 · Drug: Placebo

  • Experimental
    MAD Cohort1

    JKN2501 F mg

    Drug: JKN2501 · Drug: Placebo

  • Experimental
    MAD Cohort2

    JKN2501 G mg

    Drug: JKN2501 · Drug: Placebo

  • Experimental
    MAD Cohort3

    JKN2501 H mg

    Drug: JKN2501 · Drug: Placebo

Interventions

  • DrugJKN2501

    Administration: Intravenous (IV) infusion.

  • DrugPlacebo

    0.9% Sodium Chloride Injection as Placebo. Administration: Intravenous (IV) infusion.

06

What researchers measure

Primary outcomes

  1. To evaluate the safety and tolerability of single and multiple intravenous (IV) infusions of JKN2501 for Injection in healthy adults.

    Number of participants with treatment-related adverse events as assessed by CTCAE V5.0. An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

    Time frame: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.

Secondary outcomes

  1. Pharmacokinetic parameter of JKN2501: Tmax

    Time frame: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.

  2. Pharmacokinetic parameter of JKN2501: Cmax

    Time frame: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.

  3. Pharmacokinetic parameter of JKN2501: t1/2

    Time frame: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.

  4. Pharmacokinetic parameter of JKN2501: AUC0-t

    Time frame: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.

  5. Pharmacokinetic parameter of JKN2501: AUC0-∞

    Time frame: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.

  6. Pharmacokinetic parameter of JKN2501: CL

    Time frame: SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose.

07

Study locations

1 of 1 sites recruiting
  • The Third hospital of Changsha
    Changsha, Hunan 410035, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07207291
Lead sponsor
Joincare Pharmaceutical Group Industry Co., Ltd
Responsible party
Sponsor
First posted
Oct 3, 2025
Start date
Aug 22, 2025
Primary completion
Mar 19, 2026 (estimated)
Completion
Mar 19, 2026 (estimated)
Last update
Oct 3, 2025

Study contacts

Yin Yang
Contact
overseas@joincare.com
+86-0755-33268688

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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