Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 45 Women only

B-3E07 vs Forsteo biosimilarity in healthy adult women

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

Run by Syneos Health · NCT07497503 · Data updated 2026-11-12

This study tests whether B-3E07 behaves the same as EU-sourced Forsteo® in healthy adult women.

More Healthy Adult Male and Female Volunteers trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 45 Years
SexWomen only
Enrollment48 (estimated)
SponsorSyneos Health
Academic / other
Drugs / interventionsradiation
Locations1 site (Bayswater, Victoria)
StatusRecruiting
StartedApril 10, 2026
Main results expectedSeptember 30, 2026
Study endsOctober 14, 2026
Registry record updatedJuly 16, 2026
Trial IDNCT07497503 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Healthy adult Caucasian female volunteers aged 18-45, with BMI 18.5-30 and weight ≥45 kg, in good general health with no significant medical history.

Probably not a fit

Individuals with significant medical conditions or abnormal vital signs or ECGs may not benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial comparing the pharmacokinetics and immunogenicity of two injections, B-3E07 and Forsteo®, in healthy adult female volunteers. The study uses a crossover design to assess biosimilarity and bioavailability between the products. Participants are healthy Caucasian women aged 18-45 with BMI 18.5-30 and weight at least 45 kg, screened to exclude significant medical conditions. Primary aims include PK similarity and potential immunogenic responses, with locations in Victoria, Australia. Lead sponsor is Syneos Health, with collaboration from Yifan Pharmaceutical (Shanghai).

Why it matters

Potential benefit: If successful, the findings could support biosimilarity between B-3E07 and Forsteo®, potentially guiding future development and regulatory decisions.

How similar studies have gone: Biosimilarity assessments have been used in prior similar trials to compare PK and immunogenicity between biosimilar and reference products.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Healthy adult Caucasian female volunteers, 18-45 years of age, inclusive, at the time of consent.
2. Body Mass Index (BMI) greater than (\>)18.5 and less than or equal to (\<=) 30.0 kilograms per square meter (kg/m\^2) (inclusive) at the time of screening.
3. Body weight greater than or equal to (\>=) 45.0 kilograms (kg) at the time of screening.
4. The participant is considered by the investigator to be in good general health, defined as absence of clinically significant illness or surgery within 4 weeks prior to dosing, and no clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, or metabolic disease as determined by medical history, clinical laboratory test results vital sign measurements (systolic blood pressure \[BP\] \>=90 millimiters of mercury \[mmHg\] and \<=145 mmHg, diastolic BP \>=50 mmHg and \<=95 mmHg), 12-lead ECG results, and physical examination findings at screening and check-in (congenital nonhaemolytic hyperbilirubinemia \[for example Gilbert's syndrome\] and/or abnormal findings without clinical significance are acceptable).
5. Absence of tattoos, scars, or any skin conditions, including infections or open wounds, or dermatitis at the injection site that could interfere with the evaluation of injection reaction.
6. All participants of childbearing potential must have a negative pregnancy test at screening and check-in and must agree to use a highly effective method of contraception from screening through study completion and for 30 days after the last dose. Acceptable highly effective methods of contraception include intrauterine device (IUD)/ intrauterine system (IUS), bilateral tubal occlusion, exclusive relationship with a vasectomized partner with documented azoospermia, sexual abstinence (if this is the participant's usual lifestyle) or exclusively engaging in a same-sex relationship. Male partners of female participants should also use a condom. Hormonal methods for contraception (including a hormone-releasing intrauterine system such as Mirena) or double-barrier methods (e.g., male condom with diaphragm or cervical cap) are not permitted.
7. The participant must be able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions. Participants must have signed an ICF before any study-related procedure or evaluation is performed.

Exclusion Criteria:

1. Corrected serum calcium and/or alkaline phosphatase (ALP) above the upper limit of normal (ULN) at screening and check-in.
2. Clinically significant abnormal parathyroid hormone (PTH) level and/or total cholesterol above the upper limit of normal (ULN) range or 25 hydroxyvitamin D (25OH-Vit D) less than the lower limit of normal range at screening.
3. Haemoglobin less than (\<)12 grams per decilitre (g/dL) or haematocrit \<0.32, or there is any active bleeding at screening and at check-in.
4. Positive results for hepatitis B surface antigen \[HBsAg\] and total hepatitis B core antibody \[anti-HBc\]) at screening. Participants with immunity to hepatitis B from previous natural infection (defined as negative HBsAg, positive anti-HBc, and positive hepatitis B surface antibody \[anti-HBs\]) or vaccination (defined as negative HBsAg, negative anti-HBc, and positive anti-HBs) may be included in the study.
5. Positive results for hepatitis C (HCV) and/or Positive results for human immunodeficiency (HIV) at screening.
6. Positive urine drug screen (Amphetamine, Benzodiazepine, Cocaine, Methamphetamines, Opiates, Marijuana, Methylenedioxymethamphetamine, Buprenorphine, Alcohol, Fentanyl, Tramadol, Tricyclic Antidepressants, Barbiturates, Methadone, Oxycodone, Phencyclidine) -and/or positive breath alcohol test at screening and check-in.
7. Lactating or known pregnant or positive result for serum human chorionic gonadotropin (HCG) test at screening and at check-in.
8. Postmenopausal women.
9. History or presence of bone diseases including, but not limited to, Paget's disease of bone, bone carcinoma, metastases in the bone, metabolic bone disease, known osteoporosis (except for history of traumatic bone fracture at least 90 days prior to screening) at screening.
10. History within the past 5 years and/or presence of any significant endocrine (including thyroid and parathyroid gland) disease at screening.
11. Known active urolithiasis at screening.
12. Estimated glomerular filtration rate (eGFR) \<90 milliter per minutes per 1.73 square meter (mL/min/1.73m\^2) using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method or clinically significant renal disease as judged by the Investigator.
13. History of sensitivity to study drug or its components or Escherichia coli (E. coli) derived proteins.
14. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator.
15. History within the past 90 days of continuous use (for at least 2 weeks) of any drugs or supplements affecting bone metabolism (such as bisphosphonates, calcitonin, estrogen, selective estrogen receptor modulators (SERMs), parathyroid hormone and its analogues, strontium salts, fluoride, active vitamin D and its analogues, vitamin K2, calcium supplements, etc.) at screening.
16. History of using any prescription, nonprescription medications/products, herbal remedies, supplements at screening. Use of Paracetamol up to 2 grams (g) daily and other over-the-counter medications (antihistamines, Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)) up to 72 hours prior to admission as long as more than 5 half-lives have elapsed and the investigator approves, and topical or intranasal medication with limited systemic absorption is allowed.
17. History within 3 months of external beam or implant radiation therapy involving the skeleton reported at screening.
18. Donated or lost 500 milliliters (mL) or more of whole blood, or received a blood transfusion, or used blood products within 8 weeks prior to dosing.
19. History of alcohol abuse within the past 5 years (defined as drinking more than or equal to 14 units of alcohol per week: 1 unit approximately (≈) 285 ml of beer, or 25 ml of spirits, or 100 ml of wine), or an unwillingness to adhere to visit window alcohol restrictions, or to refrain from illicit drugs throughout the study.
20. History of drug abuse within 6 months prior to Screening, defined as non-medical use of substances to achieve psychoactive effects, as determined by medical history, Investigator assessment, and /or positive drug screen.
21. History or evidence of habitual use of tobacco- or nicotine-containing products (more than 5 cigarettes per day on average) within 90 days prior to Screening and unwillingness to abstain throughout the study.
22. Previous enrolment in any other drug, device clinical study within 30 days or 5 times the half-life of the drug used in the previous study (whichever was longer) prior to Screening, or plan to take part in other clinical studies during this study.
23. Unable to refrain from using foods and beverages containing xanthines/caffeine for at least 48 hours before each investigational medicinal product (IMP) dosing and throughout the inpatient period.
24. Unable to refrain from using foods and beverages containing alcohol for at least 24 hours before each IMP dosing and throughout the inpatient period.
25. The participant has poor peripheral venous access.
26. Participants who, in the opinion of the investigator, should not participate in this study.

Where it's running

  • Veritus Research
    Bayswater, Victoria, Australia
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.