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Part A
Primary objective:
• To evaluate the safety, tolerability, and pharmacokinetic profile of a single dose of YZJ-4729 tartrate injection.
Secondary objectives:
Part B
Primary objective:
• To evaluate the safety, tolerability and pharmacokinetic profile of YZJ-4729 tartrate injection administered at the same dose and at different infusion rates .
Secondary objectives:
• To investigate the PK/PD profile of YZJ-4729 tartrate injection administered at the same dose and at different infusion rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Part A Experimental: YZJ-4729 Tartrate injection; Part A Control: YZJ-4729 simulated injection |
|
| Part B | Experimental | Subjects will receive YZJ-4729 Tartrate injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YZJ-4729 Tartrate injection | Drug | Infusion, QD |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | Part A: From Day 1 to Day 5 Part B: From Day 1 to Day 17 | |
| Incidence of participants with clinical laboratory abnormalities | Part A: From Day 1 to Day 5 Part B: From Day 1 to Day 17 | |
| Incidence of participants with vital signs abnormalities | Part A: From Day 1 to Day 5 Part B: From Day 1 to Day 17 | |
| Incidence of participants with physical exam abnormalities | Part A: From Day 1 to Day 5 Part B: From Day 1 to Day 17 | |
| Cmax | Cmax is defined as the observed maximum plasma concentration. | Pre-dose to 72 hours post-dose |
| AUCinf | AUCinf is defined as the area under the plasma concentration-time curve extrapolated to infinity from time zero. | Pre-dose to 72 hours post-dose |
| AUC0-24h | AUC0-24h is defined as the area under the plasma concentration-time curve from time zero to 24h. | Pre-dose to 72 hours post-dose |
| AUC0-t | AUC0-24h is defined as the area under the plasma concentration-time curve from time zero to the last observable concentration. | Pre-dose to 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pupil diameter | Pre-dose to 12 hours post-dose | |
| Change from baseline of QTcF by timepoint | Pre-dose to 24 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Third Hospital, Central South University | Changsha | China |
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| YZJ-4729 simulated injection |
| Drug |
Infusion, QD |
|
| t1/2z |
t1/2z is defined as the elimination half-life. |
| Pre-dose to 72 hours post-dose |
| Tmax | Tmax is defined as the observed time to reach Cmax. | Pre-dose to 72 hours post-dose |
| CL | CL is defined as the clearance. | Pre-dose to 72 hours post-dose |
| Vz | V is defined as the apparent volume of distribution. | Pre-dose to 72 hours post-dose |
| MRT | MRT is defined as the mean residence time. | Pre-dose to 72 hours post-dose |
| Ae0-t | Ae0-t is defined as the cumulative amount of drug excreted in urine or fecal from time zero to the last observable concentration. | Pre-dose to 72 hours post-dose |
| Cumulative excretion percentage of drug through urine and feces | Pre-dose to 72 hours post-dose |