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

ConditionsBacterial Infections Urinary Tract Infections Intra-Abdominal Infections Respiratory Tract Infections

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-45

SponsorJoincare Pharmaceutical Group Industry Co., Ltd

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 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

JKN2501
Drug
Administration: Intravenous (IV) infusion.
Placebo
Drug
0.9% Sodium Chloride Injection as Placebo. Administration: Intravenous (IV) infusion.

Treatment groups

66 Participants

are divided into 8 treatment groups

Treatment groups

See each treatment group below.

Group A: SAD Cohort1Experimental treatment 1 intervention

Group B: SAD Cohort2Experimental treatment 2 interventions

Group C: SAD Cohort3Experimental treatment 2 interventions

Group D: SAD Cohort4Experimental treatment 2 interventions

Group E: SAD Cohort5Experimental treatment 2 interventions

Group F: MAD Cohort1Experimental treatment 2 interventions

Group G: MAD Cohort2Experimental treatment 2 interventions

Group H: MAD Cohort3Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

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