A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product Presentations

• Status: Completed
• Trial end date: 2019-04-19
• Target enrollment: 0
• Participant gender: Male

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 to somatrogon in VIAL administered sc in healthy male volunteers.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Opko Biologics; OPKO Health, Inc.

Criteria

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:

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