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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Biological: Forsteo®; Biological: B-3E07

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Dr. Benjamin Snyder, MBBS, FRACP; Phone Number: 613 8736 1750; Email: bensnyder@veritusresearch.com

Study Locations

• Australia
  • Victoria
    • Bayswater, Victoria, Australia, 3153
      • Recruiting
      • Veritus Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1: B-3E07 Followed by Forsteo ®; Participants will receive the B-3E07 as a single subcutaneous (SC) injection on Day 1 of Period 1 followed by the Forsteo® on Day 1 of Period 2. There will be a 14-day washout between each dosing (Day 1 of each period) and a follow-up of 14-days after the last dose.	Biological: Forsteo®; Forsteo® will be administered as SC injection.; Biological: B-3E07; B-3E07 will be administered as SC injection.
Active Comparator: Sequence 2: Forsteo® Followed by B-3E07; Participants will receive the Forsteo® as a single SC injection on Day 1 of Period 1 followed by the B-3E07 on Day 1 of Period 2. There will be a 14-day washout between each dosing (Day 1 of each period) and a follow-up of 14-day after the last dose.	Biological: Forsteo®; Forsteo® will be administered as SC injection.; Biological: B-3E07; B-3E07 will be administered as SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Plasma Concentration (Cmax) of B-3E07	Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC 0-inf) of B-3E07	Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose
Cmax of Forsteo®	Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose
AUC 0-inf of Forsteo®	Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Area Under the Plasma Concentration-time Curve up to Time t (AUC 0-t) of B-3E07 and Forsteo®	Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose
Time to Attain Maximal Plasma Concentration (Tmax) of B-3E07 and Forsteo®	Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose
Terminal Elimination Half-life (t1/2) of B-3E07 and Forsteo®	Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose
Volume of Distribution (Vz/F) of B-3E07 and Forsteo®	Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose
Apparent Clearance (CL/F) of B-3E07 and Forsteo®	Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose
Maximum Observed Effect (Emax) of B-3E07 and Forsteo®	Treatment Periods 1 and 2: Pre-dose and up to 24 hours post-dose
Area Under the Effect-time Curve to the Last Measurable Time Point (AUEC 0-t) of B-3E07 and Forsteo®	Treatment Periods 1 and 2: Pre-dose and up to 24 hours post-dose
Time to Attain Maximal Serum Concentration (Tmax) of B-3E07 and Forsteo®	Treatment Periods 1 and 2: Pre-dose and up to 24 hours post-dose
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	From baseline up to End of Study (EOS)/ Early termination (ET) (up to 53 days)
Number of Participants With Injection Site Reactions	Baseline up to 14 days
Number of Participants With Clinically Significant Changes in Vital Signs, 12-lead Electrocardiograph (ECG), Physical Examinations, and Laboratory Test Results	From baseline up to EOS/ ET (up to 53 days)
Percentage of Participants With Positive Antidrug antibodies (ADA) and ADA Titers to B-3E07 and Forsteo®	Baseline up to 14 days

Collaborators and Investigators

• Sponsor: Syneos Health
• Collaborators: Yifan Pharmaceutical (Shanghai) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2026
• Primary Completion (Estimated): June 10, 2026
• Study Completion (Estimated): June 24, 2026

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Crossover; Immunogenicity; Bio similarity
• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Parathyroid Hormone; Teriparatide
• Other Study ID Numbers: YF-B07-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No