Actively Recruiting
A Study of B-3E07 and Forsteo® in Healthy Adult Female Participants
Led by Syneos Health · Updated on 2026-05-14
48
Participants Needed
1
Research Sites
10 weeks
Total Duration
On this page
Sponsors
S
Syneos Health
Lead Sponsor
Y
Yifan Pharmaceutical (Shanghai) Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Study of B-3E07 and Forsteo® in Healthy Adult Female Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adult Caucasian female volunteers aged 18 to 45 years at the time of consent
- Body Mass Index (BMI) greater than 18.5 and less than or equal to 30.0 kg/m² at screening
- Body weight greater than or equal to 45.0 kilograms at screening
- Considered in good general health without significant illness or surgery within 4 weeks prior to dosing
- No clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, or metabolic disease
- No tattoos, scars, skin infections, open wounds, or dermatitis at the injection site
- Negative pregnancy test at screening and check-in for participants of childbearing potential
- Agreement to use a highly effective contraception method from screening through study completion and for 30 days after last dose
- Ability to understand and sign informed consent and comply with study restrictions
You will not qualify if you...
- Corrected serum calcium and/or alkaline phosphatase above normal limits at screening and check-in
- Abnormal parathyroid hormone, total cholesterol above normal, or low 25 hydroxyvitamin D levels at screening
- Hemoglobin less than 12 g/dL or hematocrit less than 0.32, or active bleeding at screening
- Positive hepatitis B surface antigen or total hepatitis B core antibody at screening (except immune or vaccinated participants)
- Positive hepatitis C or HIV results at screening
- Positive urine drug screen or breath alcohol test at screening and check-in
- Lactating, pregnant, or positive serum human chorionic gonadotropin test at screening and check-in
- Postmenopausal women
- History or presence of bone diseases including Paget's disease, bone carcinoma, bone metastases, metabolic bone disease, or known osteoporosis (except traumatic fracture over 90 days prior)
- Significant endocrine disease within past 5 years
- Active urolithiasis at screening
- Estimated glomerular filtration rate less than 90 mL/min/1.73 m² or significant renal disease
- Sensitivity to study drug, components, or Escherichia coli derived proteins
- Significant hypersensitivity or allergy to drugs, food, or substances unless approved
- Continuous use within 90 days of drugs or supplements affecting bone metabolism
- Use of prescription or nonprescription medications, herbal remedies, or supplements at screening, except approved over-the-counter medications
- External beam or implant radiation therapy involving skeleton within past 3 months
- Blood donation or transfusion within 8 weeks prior to dosing
- History of alcohol abuse in past 5 years or unwillingness to follow alcohol and illicit drug restrictions
- Drug abuse within 6 months prior to screening
- Habitual tobacco or nicotine use over 5 cigarettes per day within 90 days prior and unwillingness to abstain
- Participation in other drug or device clinical studies within 30 days or 5 drug half-lives prior to screening
- Inability to avoid caffeine or alcohol for required times before dosing
- Poor peripheral venous access
- Any condition that investigator judges as unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Veritus Research
Bayswater, Victoria, Australia, 3153
Actively Recruiting
Research Team
D
Dr. Benjamin Snyder, MBBS, FRACP
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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