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NOT YET RECRUITING
NCT07497503
PHASE1

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

Sponsor: Syneos Health

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-04-10

Completion Date

2026-06-11

Last Updated

2026-03-27

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

Forsteo®

Forsteo® will be administered as SC injection.

BIOLOGICAL

B-3E07

B-3E07 will be administered as SC injection.

Locations (1)

Veritus Research

Bayswater, Victoria, Australia