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

NCT07207291 | Recruiting Phase 1

• 1 other identifier: JKN2501-I-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

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

Keywords

Bacterial Infections

Outcome Measures

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.

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

Secondary Outcomes (6)

• Pharmacokinetic parameter of JKN2501: Tmax

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

• Pharmacokinetic parameter of JKN2501: Cmax

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

• Pharmacokinetic parameter of JKN2501: t1/2

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

• Pharmacokinetic parameter of JKN2501: AUC0-t

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

• Pharmacokinetic parameter of JKN2501: AUC0-∞

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

Study Arms (8)

SAD Cohort1

EXPERIMENTAL

JKN2501 125mg only, without placebo.

Drug: JKN2501

SAD Cohort2

EXPERIMENTAL

JKN2501 B mg

Drug: JKN2501; Drug: Placebo

SAD Cohort3

EXPERIMENTAL

JKN2501 C mg

Drug: JKN2501; Drug: Placebo

SAD Cohort4

EXPERIMENTAL

JKN2501 D mg

Drug: JKN2501; Drug: Placebo

SAD Cohort5

EXPERIMENTAL

JKN2501 E mg

Drug: JKN2501; Drug: Placebo

MAD Cohort1

EXPERIMENTAL

JKN2501 F mg

Drug: JKN2501; Drug: Placebo

MAD Cohort2

EXPERIMENTAL

JKN2501 G mg

Drug: JKN2501; Drug: Placebo

MAD Cohort3

EXPERIMENTAL

JKN2501 H mg

Drug: JKN2501; Drug: Placebo

Interventions

JKN2501 DRUG

Administration: Intravenous (IV) infusion.

MAD Cohort1; MAD Cohort2; MAD Cohort3; SAD Cohort1; SAD Cohort2; SAD Cohort3; SAD Cohort4; SAD Cohort5

Placebo DRUG

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

MAD Cohort1; MAD Cohort2; MAD Cohort3; SAD Cohort2; SAD Cohort3; SAD Cohort4; SAD Cohort5

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joincare Pharmaceutical Group Industry Co., Ltd: lead

Study Sites (1)

The Third hospital of Changsha

Changsha, Hunan, 410035, China

RECRUITING

MeSH Terms

Conditions

Bacterial Infections; Urinary Tract Infections; Intraabdominal Infections; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Respiratory Tract Diseases

Central Study Contacts

Yin Yang

CONTACT

+86-0755-33268688; overseas@joincare.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: October 3, 2025
• Study Start: August 22, 2025
• Primary Completion: March 19, 2026
• Study Completion: March 19, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)