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

NCT07207291 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-10-03

No results posted yet for this 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.

Conditions

Interventions

DRUG

JKN2501

Administration: Intravenous (IV) infusion.

DRUG

Placebo

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

Sponsors & Collaborators

  • Joincare Pharmaceutical Group Industry Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-22
Primary Completion
2026-03-19
Completion
2026-03-19

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07207291 on ClinicalTrials.gov