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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAD Cohort1 | Experimental | JKN2501 125mg only, without placebo. |
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| SAD Cohort2 | Experimental | JKN2501 B mg |
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| SAD Cohort3 | Experimental | JKN2501 C mg |
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| SAD Cohort4 | Experimental | JKN2501 D mg |
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| SAD Cohort5 | Experimental | JKN2501 E mg |
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| MAD Cohort1 | Experimental | JKN2501 F mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JKN2501 | Drug | Administration: Intravenous (IV) infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yin Yang | Contact | +86-0755-33268688 | overseas@joincare.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third hospital of Changsha | Recruiting | Changsha | Hunan | 410035 | China |
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| MAD Cohort2 |
| Experimental |
JKN2501 G mg |
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| MAD Cohort3 | Experimental | JKN2501 H mg |
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| Placebo | Drug | 0.9% Sodium Chloride Injection as Placebo. Administration: Intravenous (IV) infusion. |
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| 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. |
| Pharmacokinetic parameter of JKN2501: CL | SAD: Baseline to Day 8 post-dose. MAD: Baseline to Day 18 post-dose. |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D014552 | Urinary Tract Infections |
| D059413 | Intraabdominal Infections |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012140 | Respiratory Tract Diseases |
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