Trials / Recruiting
RecruitingNCT07207291
Phase I Study of Single/Multiple Ascending Doses of JKN2501 for Injection in Chinese Healthy Volunteers
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- Sponsor
- Joincare Pharmaceutical Group Industry Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | JKN2501 | Administration: Intravenous (IV) infusion. |
| DRUG | Placebo | 0.9% Sodium Chloride Injection as Placebo. Administration: Intravenous (IV) infusion. |
Timeline
- Start date
- 2025-08-22
- Primary completion
- 2026-03-19
- Completion
- 2026-03-19
- First posted
- 2025-10-03
- Last updated
- 2025-10-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07207291. Inclusion in this directory is not an endorsement.