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The main purposes of this study are to determine:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TG103 | Experimental | Escalating doses of TG103 administered subcutaneously (SC) once in healthy participants. |
|
| Placebo | Placebo Comparator | Placebo administered SC once in healthy participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TG103 | Drug | Administered SC |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module | Baseline through Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) | Area under the plasma concentration versus time curve (AUC) after administration of of TG103 | 0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648h |
| Peak Plasma Concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jintong li | China-Japan Friendship Hospital | Principal Investigator |
| li chen | China-Japan Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37062422 | Derived | Jin J, Cui G, Mi N, Wu W, Zhang X, Xiao C, Wang J, Qiu X, Han M, Li Z, Wang L, Lu T, Niu H, Wu Z, Li J. Safety, pharmacokinetics, and pharmacodynamics of TG103, a novel long-acting GLP-1/Fc fusion protein after a single ascending dose in Chinese healthy subjects. Eur J Pharm Sci. 2023 Jun 1;185:106448. doi: 10.1016/j.ejps.2023.106448. Epub 2023 Apr 14. |
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Double
| Drug |
Administered SC |
|
Peak Plasma Concentration (Cmax) after administration of of TG103
| 0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648h |
| Time to maximum plasma concentration(Tmax) | Time to maximum plasma concentration(Tmax)after administration of of TG103 | 0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648hours |
| Half time (t1/2) | The half time of TG103 after administration are calculated. | 0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648hours |
| Apparent clearance (CL/F) | To assess the apparent clearance (CL/F) after administration of TG103 | 0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648hours |
| Fasting blood glucose | Changes in Fasting blood glucose compared to baseline | 1,2,3,4,5,7days |
| 2-hour postprandial blood glucose | Changes in 2-hour postprandial blood glucose compared to baseline | 1,2,3,4,5,7days |
| fasting insulin | Changes in fasting insulin compared to baseline | -1,3days |
| fasting glucagon | Changes in fasting glucagon compared to baseline | -1,3days |