Trials / Not Yet Recruiting
Not Yet RecruitingNCT07497503
A Study of B-3E07 and Forsteo® in Healthy Adult Female Participants
A Randomised, Double-Blind, Two-Sequence, Single-Dose, Crossover Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity Profile of B-3E07 and Forsteo in Healthy Adult Female Participants
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Syneos Health · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Forsteo® | Forsteo® will be administered as SC injection. |
| BIOLOGICAL | B-3E07 | B-3E07 will be administered as SC injection. |
Timeline
- Start date
- 2026-04-10
- Primary completion
- 2026-05-29
- Completion
- 2026-06-11
- First posted
- 2026-03-27
- Last updated
- 2026-03-27
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT07497503. Inclusion in this directory is not an endorsement.