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This is a phase I clinical study on dose escalation evaluating the safety, tolerability, PK and PD of a single dose of AK139 administered subcutaneously in healthy subjects.
This is a phase I, dose escalation clinical study aimed to evaluate the safety, tolerability, PK and PD of AK139 in healthy subjects. This study will be conducted in a dose escalation design, sequentially increasing the dosage of the drug from low to high to complete a single subcutaneous dose escalation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK139 regimen | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Monitor for a minimum of 24 hours to assess whether the safety and tolerability are acceptable according to the investigator. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AE) | The incidence of AEs . An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax) | Measure and assess the Cmax of AK139. | Week 0 to week 12 |
| Time to peak (Tmax) | Measure and assess the Tmax of AK139 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoqin Wang | Contact | 86 (0760) 8987 3999 | global.trials@akesobio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Xiaoshan Hospital | Hangzhou | Zhejiang | China |
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| AK111 | Drug | The study will use dose escalation scheme. Before proceeding to randomize the next group of subjects, the safety data from all subjects in the previous dose group must be reviewed and confirmed. |
|
| Week 0 to week 12 |
| Area under the curve (AUC) | Measure and assess the AUC of AK139 | Week 0 to week 12 |
| Half-life (t1/2) | Measure and assess the t1/2 of AK139. | Week 0 to week 12 |
| Anti-drug antibody (ADA) | Measure and assess the ADA of AK139. | Week 0/2/4/8/12 |