Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Somatrogon · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Somatrogon pre-filled PEN | EXPERIMENTAL | - |
| Somatrogon frozen liquid formulation | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Somatrogon | DRUG | A single dose of 12 mg of somatrogon will be injected as one sc injection to the arm on each dosing day (Day 0 and Day 14). |
Inclusion Criteria: * Healthy male volunteers aged 18-55 (inclusive) years * Body Mass Index (BMI) 19 to 32 kg/m2 (inclusive) and weighing at least 55 kg * Non-smoking (by declaration) for a period of at least six months prior to screening visit Exclusion Criteria: \-
Somatrogon is an investigational small molecule being studied in healthy male volunteers. A completed Phase 1 clinical trial evaluated the comparability of Somatrogon in two different drug product presentations. The study enrolled 49 healthy male participants aged 18 years and older in the United States.
Somatrogon is being developed by Opko Health Inc., a company traded under the ticker symbol OPK. The drug is currently in Phase 1 clinical development, with one completed trial involving healthy male volunteers.
Somatrogon is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and no active trials are currently listed for this asset.
Somatrogon has one completed clinical trial registered under NCT03810664, titled 'A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations.' This Phase 1 study enrolled 49 healthy male volunteers in the United States and was active-controlled but not double-blinded.
Somatrogon is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The only completed trial, NCT03810664, was a Phase 1 study in healthy male volunteers, and the drug remains under investigation.