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The purpose of this study is to determine the safety, tolerability, pharmacokinetics、 pharmacodynamics and immunogenicity of BPR-30221616 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPR-30221616 Injection | Experimental |
| |
| Sodium Chloride Injection | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BPR-30221616 Injection | Drug | BPR-30221616 will be administered by subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Participants With Adverse Events (AE) | Up to Day 360 | |
| Incidence of Participants With Serious Adverse Events (SAE) | Up to Day 360 | |
| Incidence of Participants With Clinically Significant laboratory tests, electrocardiogram (ECG), physical examination, vital signs | Up to Day 360 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax)of BPR-30221616 | Day 1 through to Day 3 | |
| Time to maximum plasma concentration(Tmax) of BPR-30221616 | Day 1 through to Day 3 | |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of BPR-30221616 on serum Vitamin A levels as measured by reduction from baseline in serum Vitamin A | Day 1 through to Day 540 | |
| Effect of BPR-30221616 on serum Retinol-Binding Protein(RBP) levels as measured by reduction from baseline in serum RBP | Day 1 through to Day 540 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Contact | China/Beijing+010-69154796 | hanxiaohong@pumch.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Sodium Chloride Injection | Drug | Sodium Chloride Injection will be administered by SC injection |
|
| Area under the plasma concentration-time curve(AUC)of BPR-30221616 |
| Day 1 through to Day 3 |
| Elimination rate constant (λz) of BPR-30221616 | Day 1 through to Day 3 |
| Elimination half-life (t1/2) of BPR-30221616 | Day 1 through to Day 3 |
| Apparent volume of distribution during terminal phase (Vz/F) of BPR-30221616 | Day 1 through to Day 3 |
| Clearance (CL/F) of BPR-30221616 | Day 1 through to Day 3 |
| Mean residence time from zero to infinity (MRT0-∞) of BPR-30221616 | Day 1 through to Day 3 |
| Cumulative amount of the dose excreted unchanged in urine (Ae) of BPR-30221616 | Day 1 through to Day 3 |
| Cumulative fraction of the dose excreted unchanged in urine (Fe) of BPR-30221616 | Day 1 through to Day 3 |
| Renal clearance(CLr) of BPR-30221616 | Day 1 through to Day 3 |
| Effect of BPR-30221616 on serum transthyretin(TTR) levels as measured by reduction from baseline in serum TTR | Day 1 through to Day 540 |
| Number of participants who develop serum anti-BPR-30221616 antibodies | Day 1 through to Day 360 |
| D017670 |
| Sodium Compounds |