Status:
COMPLETED
A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations
Lead Sponsor:
OPKO Health, Inc.
Conditions:
Healthy Male Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This is a Phase 1, single-center, open-label randomized, 2×2 crossover (Ref Test \| Test Ref) study with a washout of two weeks to establish bioequivalence between single dose of somatrogon in a PEN t...
Detailed Description
The subjects will undergo a screening period (Day -28 to -1), and when eligible for study participation will be randomized to receive one sc injection of one of two somatrogon drug product presentatio...
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
January 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 19 2019
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03810664
Start Date
January 18 2019
End Date
April 19 2019
Last Update
April 28 2020
Active Locations (1)
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1
QPS Miami Research Associates
Miami, Florida, United States, 33143