drugset / Trial / NCT01225666
MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA)
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims to assess the safety, tolerability and Pharmacokinetics/ Pharmacodynamics (PK/PD) profile of three doses of MOD-4023 on a weekly regime and one dose on an every-other-week regime administered for a period of 4 weeks in Growth Hormone Deficient Adult (GHDA) patients who previously were on a stable r-hGH treatment. An additional extension period of 16 weeks once-weekly administration of MOD-4023 aims to confirm the dose selection for future trials.
Timeline
- Start
- 2010-08
- Primary completion
- 2011-07
- Completion
- 2012-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Somatrogon | Protein / enzyme biologic | 30 % | Subcutaneous |
| Subject | Somatrogon | Protein / enzyme biologic | 45 % | Subcutaneous |
| Subject | Somatrogon | Protein / enzyme biologic | 100 % | Subcutaneous |