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

NCT07497503 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-05-14

No results posted yet for this study

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

  • Healthy Volunteers

Interventions

BIOLOGICAL

Forsteo®

Forsteo® will be administered as SC injection.

BIOLOGICAL

B-3E07

B-3E07 will be administered as SC injection.

Sponsors & Collaborators

  • Yifan Pharmaceutical (Shanghai) Co., Ltd.

    collaborator UNKNOWN

  • Syneos Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-10
Primary Completion
2026-06-10
Completion
2026-06-24

Countries

  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07497503 on ClinicalTrials.gov