Comparative PK Study of ENZ201 Teriparatide and Forsteo
Research type
Research Study
Full title
A Randomized, Assessor-Blind, Balanced, Single-Dose, 2-Way Crossover Comparative Bioavailability Study of ENZ201, Teriparatide (20 µg) from Enzene Biosciences Ltd. Versus EU Reference Product, Forsteo® Teriparatide (20 µg) from Eli-Lilly in Healthy Male Subjects under Fasting Conditions
IRAS ID
274503
Contact name
Sunu Valasseri
Contact email
Sponsor organisation
Enzene Biosciences Ltd
Eudract number
2019-004242-15
Duration of Study in the UK
0 years, 1 months, 20 days
Research summary
The clinical trial investigational medicine, ENZ201 (teriparatide injection), is experimental. That means the Medicines and Health Care Regulatory Agency (MHRA) has not approved it for sale or use. ENZ201 is being studied with an aim to develop it as a treatment for Osteoporosis (weakening of bones because bone thinning) in future.
The other investigational medicine that will be used in this trial is called Forsteo®. This medication has been approved by the FDA (American drug licensing agency) since 2002 and the EU since 2003 and is indicated for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture, and for the treatment of osteoporosis associated with sustained systemic glucocorticoid (a type of steroid medicine) therapy in women and men at increased risk for fracture.
The main aims of this clinical trial are to compare the rate of drug absorption (PK) and the subsequent blood levels observed after dosing with ENZ201 and with Forsteo®.
The other purposes of this clinical trial are to:
• Compare the levels of calcium in the blood, after dosing with ENZ201 and with
Forsteo®.
• Learn about the safety of ENZ201.
• Learn how subjects tolerate ENZ201.REC name
HSC REC A
REC reference
19/NI/0202
Date of REC Opinion
2 Dec 2019
REC opinion
Further Information Favourable Opinion