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The objectives of the study are to evaluate the safety , tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single ascending intravenous (IV) doses of 9MW3011 in Chinese healthy volunteers.
The single ascending dose(SAD) study will comprise 6 dose cohorts of 8 healthy volunteers each. In each cohort, subjects will be randomized in a 6:2 ratio to receive 9MW3011 or placebo via intravenous infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 9MW3011 Dose 1 | Experimental | Ascending IV doses administered per protocol |
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| 9MW3011 Dose 2 | Experimental | Ascending IV doses administered per protocol |
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| 9MW3011 Dose 3 | Experimental | Ascending IV doses administered per protocol |
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| 9MW3011 Dose 4 | Experimental | Ascending IV doses administered per protocol |
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| 9MW3011 Dose 5 | Experimental | Ascending IV doses administered per protocol |
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| 9MW3011 Dose 6 | Experimental | Ascending IV doses administered per protocol |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9MW3011 | Drug | Single dose intravenously on day 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event(including serious adverse event) | The incidence of AEs and SAEs from treatment until the last scheduled follow-up visit | up to day 99 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with abnormal vital signs | Vital signs measurements will include pulse rate, respiration rate, blood pressure (systolic and diastolic blood pressure) and body temperature. | up to day 99 |
| Number of subjects with abnormal clinically significant results from physical examination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PKUcare Luzhong Hospital | Zibo | Shandong | China |
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| 9MW3011 placebo | Drug | Single dose intravenously on day 1 |
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The physical examinations will include examination of the following: skin and mucous membranes, lymph nodes, head and neck, chest, abdomen, musculoskeletal, nervous system, and other sites of note elicited from the subject. |
| up to day 99 |
| Number of subjects with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters | The examination indicators include heart rate, PR, QRS, uncorrected QT, and QTcF(corrected by Fridericia formula). | up to day 99 |
| Number of subjects with abnormal clinically significant clinical laboratory results | Clinical laboratory tests include hematology, urinalysis, blood chemistry, coagulation function. | up to day 99 |
| Cmax | The peak concentration | up to day 85 |
| AUC0-t | The area under the concentration-time curve from zero to the last time point | up to day 85 |
| AUC0-∞ | The area under the concentration-time curve from zero to infinity | up to day 85 |
| Tmax | The time to reach peak concentration | up to day 85 |
| λz | Terminal elimination rate constant | up to day 85 |
| t1/2z | The terminal elimination half-life | up to day 85 |
| Vz | The volume of distribution | up to day 85 |
| CL | Clearance | up to day 85 |
| MRT | Mean residence time | up to day 85 |
| Pharmacodynamic(PD)parameters-hepcidin | Change from baseline in hepcidin levels | up to day 85 |
| PD parameters-serum iron | Change from baseline in serum iron levels | up to day 85 |
| PD parameters-TSAT | Change from baseline in transferrin saturation(TSAT) levels | up to day 85 |
| Anti-drug antibodies(ADA) | The incidence of ADA | up to day 85 |