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Double-blind, randomized, placebo and active controlled dose-ascending study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of ACP-001 (TransCon PEG hGH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACP-001, dose-level 1 | Experimental |
| |
| ACP-001, dose-level 2 | Experimental |
| |
| ACP-001, dose-level 3 | Experimental |
| |
| ACP-001, dose-level 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACP-001 (TransCon PEG hGH) | Drug | ACP-001, dose-level 1, s.c., single-dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability (adverse events, local reactions, immunogenicity) | 0-42 days | |
| Pharmacokinetics; AUC and Cmax for hGH, TransCon-PEG hGH; and Pharmacodynamics measured by IGF-1 and IFG-BP | 0-28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ascendis Pharma | Ascendis Pharma A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto | Ontario | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29273485 | Derived | Gilfoyle D, Mortensen E, Christoffersen ED, Leff JA, Beckert M. A first-in-man phase 1 trial for long-acting TransCon Growth Hormone. Growth Horm IGF Res. 2018 Apr;39:34-39. doi: 10.1016/j.ghir.2017.12.002. Epub 2017 Dec 5. |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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| ACP-001 (TransCon PEG hGH) |
| Drug |
ACP-001, dose-level 2, s.c., single-dose |
|
| ACP-001 (TransCon PEG hGH) | Drug | ACP-001, dose-level 3, s.c., single-dose |
|
| ACP-001 (TransCon PEG hGH) | Drug | ACP-001, dose-level 4, s.c., single-dose |
|
| Placebo | Drug | Placebo, s.c., single-dose |
|
| Human Growth Hormone | Drug | Human Growth Hormone, s.c., daily for 7 days |
|
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |