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This is a randomized, open-label, parallel-controlled study to compare the PK, safety, and immunogenicity of CM326 administered via different delivery devices in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM326 group 1 | Experimental | Subjects will receive a single subcutaneous injection of CM326 on Day 1. |
|
| CM326 group 2 | Experimental | Subjects will receive a single subcutaneous injection of CM326 on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM326(formulation 1) | Drug | subcutaneous injection |
| |
| CM326(formulation 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) | To compare the Cmax of CM326 administered via different delivery devices | Pre-dose at day 1 to Day 113 |
| Area under the concentration-time curve from zero to infinity (AUCinf) | To compare the AUCinf of CM326 administered via different delivery devices | Pre-dose at day 1 to Day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum concentration (Tmax) | To characterize the Tmax of CM326 in healthy subjects | Pre-dose at day 1 to Day 113 |
| Area under the concentration-curve from zero to the last quantifiable concentration (AUClast) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | +86-0311-69085587 | ctr-contact@cspc.cn | |
| Wei Hu | Contact | +86-13856086475 | huwei@ahmu.edu.com |
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| Drug |
subcutaneous injection |
|
To characterize the AUClast of CM326 in healthy subjects
| Pre-dose at day 1 to Day 113 |
| Terminal elimination half-life (t1/2) | To characterize the t1/2 of CM326 in healthy subjects | Pre-dose at day 1 to Day 113 |
| Apparent clearance (CL/F) | To characterize the Vz/F of CM326 in healthy subjects | Pre-dose at day 1 to Day 113 |
| Apparent volume of distribution (Vz/F) | To characterize the Vz/F of CM326 in healthy subjects | Pre-dose at day 1 to Day 113 |
| Number of subjects with adverse events as Assessed by CTCAE v6.0 | To assess the safety of CM326 in healthy subjects | Pre-dose at day 1 to Day 113 |
| Incidence of ADA | To assess the immunogenicity of CM326 in healthy subjects | Pre-dose at day 1 to Day 113 |