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This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered JMT202 in Healthy Participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JMT202 SAD experimental group | Experimental | Participants in SAD experimental groups will receive a single subcutaneous injection of JMT202 on Day 1. |
|
| Placebo SAD group | Placebo Comparator | Participants in SAD experimental groups will receive a single subcutaneous injection of placebo on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMT202 | Drug | subcutaneous injection |
| |
| Placrbo |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of adverse events (AEs) electrocardiograms | To investigate the safety and tolerability by assesment of AEs following administration. | Pre-dose and multiple timepoints no less than 50 days |
| Number of participants with clinically significant change from baseline in vital signs | Pre-dose and multiple timepoints no less than 50 days | |
| Number of participants with clinically significant change from baseline in electrocardiogram (ECG) findings | Pre-dose and multiple timepoints no less than 50 days | |
| Number of participants with clinically significant abnormalities in physical examination | Pre-dose and multiple timepoints no less than 50 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from 0 to the collection time t (AUC0-t) | Pre-dose and multiple timepoints no less than 50 days | |
| Area under the concentration-time curve from 0 to infinity (AUC0-∞) | Pre-dose and multiple timepoints no less than 50 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianping Li, doctor | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijin | China |
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Drug: JMT202 Other: Placebo
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| Drug |
subcutaneous injection |
|
| Time to maximum concentration (Tmax) | Pre-dose and multiple timepoints no less than 50 days |
| Serum Maximum concentration (Cmax) | Pre-dose and multiple timepoints no less than 50 days |
| Half-Life (t1/2) | Pre-dose and multiple timepoints no less than 50 days |
| Anti-drug antibody (ADA) prevalence in blood before study treatment and at the Follow-up Visit | Pre-dose and multiple timepoints no less than 50 days |
| Absolute change in High molecular weight adiponectin | Pre-dose and multiple timepoints no less than 50 days |
| Absolute change in weight | Pre-dose and multiple timepoints no less than 50 days |
| Absolute change in glycosylated hemoglobin | Pre-dose and multiple timepoints no less than 50 days |
| Absolute change in fasting insulin level | Pre-dose and multiple timepoints no less than 50 days |
| Absolute change in fasting glucose | Pre-dose and multiple timepoints no less than 50 days |
| Absolute change in blood lipoprotein | Pre-dose and multiple timepoints no less than 50 days |