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A Study of B-3E07 and Forsteo® in Healthy Adult Female Participants Phase 1 48

Not yet recruiting
Clinical Trial NCT07497503 is designed to study Other for Healthy Volunteers. This Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on April 10, 2026 until the study accrues 48 participants. Led by Syneos Health, this study is expected to complete by June 11, 2026. The latest data from ClinicalTrials.gov was last updated on March 27, 2026.
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.
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

Conditions
Healthy Volunteers
Other Study IDs
  • YF-B07-001
NCT ID Number
NCT07497503
Start Date (Actual)
2026-04-10
Last Update Posted
2026-03-27
Completion Date (Estimated)
2026-06-11
Enrollment (Estimated)
48
Study Type
Interventional
PHASE
Phase 1
Status
Not yet recruiting
Keywords
Crossover
Pharmacokinetics
Immunogenicity
Biosimilarity
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSequence 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 3-day washout between each dosing (Day 1 of each period) and a follow-up of 3 to 7 days after the last dose.
Forsteo®
Forsteo® will be administered as SC injection.
B-3E07
B-3E07 will be administered as SC injection.
Active ComparatorSequence 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 3-day washout between each dosing (Day 1 of each period) and a follow-up of 3 to 7 days after the last dose.
Forsteo®
Forsteo® will be administered as SC injection.
B-3E07
B-3E07 will be administered as SC injection.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Maximum Plasma Concentration (Cmax) of B-3E07 and Forsteo®
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 and Forsteo®
Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 35 days)
Number of Participants With Injection Site Reactions
From baseline up to EOS/ET (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 35 days)
Percentage of Participants With Positive Antidrug antibodies (ADA) and ADA Titers to B-3E07 and Forsteo®
From baseline up to EOS/ET (up to 14 days)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
  1. Healthy adult Caucasian female volunteers, 18-45 years of age, inclusive.
  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 methods include intrauterine device (IUD)/ intrauterine system (IUS), bilateral tubal occlusion, vasectomized partner with documented azoospermia, or sexual abstinence (if this is the participant's usual lifestyle). Hormonal methods for contraception or double-barrier methods (e.g., male condom with diaphragm or cervical cap) are not acceptable. Sexually active male partner of the female participant must use a highly effective method of contraception; for non-sterile male partners, vasectomy must be confirmed by azoospermia.
  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.

  1. Clinically significant abnormal parathyroid hormone (PTH) level at screening and check-in.
  2. Any one of corrected serum calcium, alkaline phosphatase (ALP), or fasting 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 and at check-in.
  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. 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 and no 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 24 hours before first dosing and throughout the study (screening to after last PK blood sample).
  24. Unable to refrain from using foods and beverages containing alcohol for 48 hours before first dosing and throughout the study (screening to after last PK blood sample).
  25. The participant has poor peripheral venous access.
  26. Participants who, in the opinion of the investigator, should not participate in this study.
Syneos Health logoSyneos Health
Yifan Pharmaceutical (Shanghai) Co., Ltd. logoYifan Pharmaceutical (Shanghai) Co., Ltd.
Study Central Contact
Contact: Dr. Benjamin Snyder, MBBS, FRACP, 613 8736 1750, [email protected]
1 Study Locations in 1 Countries

Victoria

Veritus Research, Bayswater, Victoria, 3153, Australia