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

NCT07497503 | Recruiting Phase 1

• 1 other identifier: YF-B07-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Crossover; Pharmacokinetics; Immunogenicity; Bio similarity

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• 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

Study Arms (2)

Sequence 1: B-3E07 Followed by Forsteo ®

EXPERIMENTAL

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®; Biological: B-3E07

Sequence 2: Forsteo® Followed by B-3E07

ACTIVE COMPARATOR

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®; Biological: B-3E07

Interventions

Forsteo® BIOLOGICAL

Forsteo® will be administered as SC injection.

Sequence 1: B-3E07 Followed by Forsteo ®; Sequence 2: Forsteo® Followed by B-3E07

B-3E07 BIOLOGICAL

B-3E07 will be administered as SC injection.

Sequence 1: B-3E07 Followed by Forsteo ®; Sequence 2: Forsteo® Followed by B-3E07

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult Caucasian female volunteers, 18-45 years of age, inclusive, at the time of consent.
• 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.
• Body weight greater than or equal to (\>=) 45.0 kilograms (kg) at the time of screening.
• 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).
• 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.
• 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.
• 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.

You may not qualify if:

• Corrected serum calcium and/or alkaline phosphatase (ALP) above the upper limit of normal (ULN) at screening and check-in.
• 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.
• 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.
• 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.
• Positive results for hepatitis C (HCV) and/or Positive results for human immunodeficiency (HIV) at screening.
• 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.
• Lactating or known pregnant or positive result for serum human chorionic gonadotropin (HCG) test at screening and at check-in.
• Postmenopausal women.
• 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.
• History within the past 5 years and/or presence of any significant endocrine (including thyroid and parathyroid gland) disease at screening.
• Known active urolithiasis at screening.
• 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.
• History of sensitivity to study drug or its components or Escherichia coli (E. coli) derived proteins.
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator.
• 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.

Sponsors & Collaborators

• Syneos Health: lead
• Yifan Pharmaceutical (Shanghai) Co., Ltd.: collaborator

Study Sites (1)

Veritus Research

Bayswater, Victoria, 3153, Australia

RECRUITING

MeSH Terms

Interventions

Teriparatide

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Central Study Contacts

Dr. Benjamin Snyder, MBBS, FRACP

CONTACT

613 8736 1750; bensnyder@veritusresearch.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: April 10, 2026
• Primary Completion: June 10, 2026
• Study Completion (Estimated): June 24, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)