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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020512-11 | EudraCT Number |
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The primary objective is to assess the safety and tolerability of the GLP-1 peptide analogue CM3.1-AC100 after repeated subcutaneous (sc) doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM3.1-AC100 | Experimental | Compound CM3.1-AC100 s.c. |
|
| Placebo | Placebo Comparator | Placebo for compound CM3.1-AC100 s.c. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM3.1-AC100 | Drug | MAD study with repeated subcutaneous (sc) doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measurements (Adverse events, ECG recordings, blood pressure, pulse, body temperature, laboratory variables, local tolerability, Nausea Intensity, anti- CM3.1-AC100 antibodies) | Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic samples for CM3.1-AC100 | Pharmacokinetics: Following the first dosing on Day 1: AUC, AUC0-t, AUC0-9h, Cmax, tmax, t1/2λz, λz, CL/F, Vz/F of CM3.1-AC100. Following multiple dosing on Day 7: AUCss, AUCss,0-t, AUCss,0-9h, Css,max, Css, min, tss,max, t1/2λz,ss, λz,ss, CLss/F, Vz,ss/F, of CM3.1-AC100. | Intense PK-sampling during the 15 hours following administration of CM3.1-AC100 during day 1 and day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Geigle, Dr. med. | CellMed AG, a subsidiary of BTG plc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International GmbH | Berlin | State of Berlin | 14050 | Germany |
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| Placebo |
| Drug |
Placebo for compound CM3.1-AC100 s.c. |
|