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Phase 1 Single Ascending Doses(SAD): Six cohorts of 53 healthy volunteers (HVs) will receive a single IV bolus injection of study drug or placebo.
Phase 1 Multiple Ascending Doses(MAD): Three cohorts of 30 HVs will receive multiple IV bolus injections of study drug or placebo every day. After 7 days of continuous administration, the safety, tolerance and Pharmacokinetic/Pharmacodynamic characteristics of multiple administrations were evaluated.
This study adopts a single-center, randomized, double-blind, placebo-controlled parallel-group, dose-escalation design.
This single ascending dose (SAD) study is designed with six dose cohorts: 5 mg, 10 mg, 20 mg, 30 mg, 45 mg, and 60 mg. A total of 53 healthy adult participants are planned to be enrolled.
Three participants are planned for the 5 mg cohort, randomized in a 2:1 ratio of investigational product to placebo. Each of the remaining five dose cohorts will enroll 10 participants, randomized in an 8:2 ratio of investigational product to placebo.
For the multiple ascending dose (MAD) part, three dose cohorts (10 mg, 20 mg, and 30 mg) are planned. A total of 30 healthy adult participants will be enrolled, with 10 participants per cohort randomized in an 8:2 ratio of investigational product to placebo.Subjects will receive once daily administration for 7 consecutive days according to the randomization scheme.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Product (KR25102 for Injection) | Experimental | Single-ascending-dose (5 mg, 10 mg, 20 mg, 30 mg, 45 mg, 60 mg) and multiple-ascending-dose (10 mg, 20 mg, 30 mg) intravenous administration of KR25102 for Injection. |
|
| Placebo | Placebo Comparator | Matching placebo for KR25102 for Injection, administered intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KR25102 for Injection | Drug | Intravenous injection of KR25102 for Injection at different dose levels in SAD and MAD cohorts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Adverse Events (AEs) | including vital signs, physical examination (neurological examination and injection-site examination included), 12-lead electrocardiogram, laboratory tests, abdominal ultrasonography, etc. | From study drug administration to 15 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Single-Dose Pharmacokinetic (PK) Parameters | AUC₀-ₜ | From study drug administration to 120 hours after single dose administration |
| Single-Dose Pharmacokinetic (PK) Parameters | AUC₀-inf |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Man Xu | Contact | +86-19979703650 | xuman@kvvit.com |
| Name | Affiliation | Role |
|---|---|---|
| Guoping Yang | The Third Xiangya Hospital, Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital, Central South University | Changsha | Hunan | 410006 | China |
Individual participant data will not be shared due to commercial confidentiality and privacy protection requirements.
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Placebo for KR25102 for Injection | Drug | Intravenous injection of matching placebo. |
|
| From study drug administration to 120 hours after single dose administration |
| Single-Dose Pharmacokinetic (PK) Parameters | Tmax | From study drug administration to 120 hours after single dose administration |
| Single-Dose Pharmacokinetic (PK) Parameters | Tlag | From study drug administration to 120 hours after single dose administration |
| Single-Dose Pharmacokinetic (PK) Parameters | Cmax | From study drug administration to 120 hours after single dose administration |
| Single-Dose Pharmacokinetic (PK) Parameters | t1/2 | From study drug administration to 120 hours after single dose administration |
| Multiple-dose Pharmacokinetic (PK) Parameters | Cmin,ss | From multiple-dose administration to 120 hours after the 7th dose |
| Multiple-dose Pharmacokinetic (PK) Parameters | Ctrough | From multiple-dose administration to 120 hours after the 7th dose |
| Multiple-dose Pharmacokinetic (PK) Parameters | Cmax,ss | From multiple-dose administration to 120 hours after the 7th dose |
| Multiple-dose Pharmacokinetic (PK) Parameters | Cav,ss | From multiple-dose administration to 120 hours after the 7th dose |
| Multiple-dose Pharmacokinetic (PK) Parameters | AUCtau,ss | From multiple-dose administration to 120 hours after the 7th dose |
| Multiple-dose Pharmacokinetic (PK) Parameters | CLss | From multiple-dose administration to 120 hours after the 7th dose |
| Multiple-dose Pharmacokinetic (PK) Parameters | Tmax,ss | From multiple-dose administration to 120 hours after the 7th dose |
| Multiple-dose Pharmacokinetic (PK) Parameters | t1/2,ss | From multiple-dose administration to 120 hours after the 7th dose |
| QTcF Interval Changes and Correlation With Plasma Drug Concentration | Changes in QTcF interval relative to baseline (ΔQTcF), changes relative to placebo (ΔΔQTcF) | From study drug administration to 24 hours after dosing |
| QTcF Interval Changes and Correlation With Plasma Drug Concentration | changes relative to placebo (ΔΔQTcF) | From study drug administration to 24 hours after dosing |