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Somatrogon

Phase 1

Healthy Male Volunteers | Small molecule | Other |Opko Health Inc.|Last Updated: Apr 28, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment49
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03810664A Clinical Study Investigating the Comparability of Somatrogon in Two Different Drug Product PresentationsPHASE1 COMPLETED 49 — — Jan 18, 2019Apr 19, 2019Apr 28, 20201 United States
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Study Endpoints
Primary Endpoints
Area under the curve (AUC) of the serum concentration-time from time 0 to a specific time (AUCt)
30 days
Area under the curve (AUC) of the serum concentration-time from time 0 to infinity (AUC∞)
30 days
Serum concentration from of maximum concentration (Cmax) of somatrogon levels in serum
30 days
Secondary Endpoints
AUCt of IGF-1 and IGFBP-3 levels
30 days
AUC∞ of IGF-1 and IGFBP-3 levels
30 days
Cmax of IGF-1 and IGFBP-3 levels
30 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Somatrogon pre-filled PENEXPERIMENTAL -
Somatrogon frozen liquid formulationACTIVE_COMPARATOR -
Interventions
NameTypeDescription
SomatrogonDRUGA 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).
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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: \-

Countries:United States
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