Clinical Trial

A Study of B-3E07 and Forsteo® in Healthy Adult Female Participants

Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
The main aim of the study is to evaluate the pharmacokinetic (PK) biosimilarity of B-3E07 and European Union (EU) - sourced Forsteo® in healthy adult female participants.
Protocol Amendment History 4 changes
notable Primary completion pushed: 2026-06-10 -> 2026-09-30 2026-07-17
minor Completion pushed: 2026-06-24 -> 2026-10-14 2026-07-17
critical Recruitment opened 2026-05-15
critical Primary endpoint(s) modified 2026-05-15
Trial Details
NCT Number NCT07497503
Lead Sponsor Syneos Health
Collaborators: Yifan Pharmaceutical (Shanghai) Co., Ltd.
Conditions Healthy Volunteers
Enrollment 48 participants
Start Date 2026-04-10
Primary Completion 2026-09-30 (estimated)
Study Completion 2026-10-14 (estimated)
Updated on ClinicalTrials.gov 2026-07-16