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Study Comparing the Safety and Effects of B-3E07 and Forsteo in Healthy Adult Women Aged 18 to 45
Led by Syneos Health · Updated on 2026-07-16
48
Participants Needed
1
Research Sites
2 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetic similarity between B-3E07 and Forsteo in healthy adult female volunteers aged 18 to 45 years. This phase 1, randomized, double-blind crossover study aims to compare how these two biologic injections behave in the body, including their safety, immune response, and drug levels in the bloodstream. Participants will receive single subcutaneous injections of B-3E07 and Forsteo in two separate treatment periods with a 14-day washout between doses. One group receives B-3E07 first, followed by Forsteo, while the other group receives Forsteo first, then B-3E07. After the final dose, there is a 14-day follow-up to monitor effects. During the study, participants will have blood samples taken before and up to 6 hours after dosing to measure maximum drug concentration and overall exposure. Additional assessments include safety monitoring for adverse events, injection site reactions, vital signs, ECGs, and laboratory tests. The study lasts approximately 53 days from dosing to final follow-up.
CONDITIONS
Brief Title
A Study of B-3E07 and Forsteo® in Healthy Adult Female Participants
Research Team
D
Dr. Benjamin Snyder, MBBS, FRACP
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