Healthy VolunteersPhase 1NCT07497503
A Study of B-3E07 and Forsteo® in Healthy Adult Female Participants
A Phase 1 study testing Forsteo® and B-3E07 in people with Healthy Volunteers, run by Syneos Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Forsteo® and B-3E07
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Apr 2026to 14 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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.
- History within 3 months of external beam or implant radiation therapy involving the skeleton reported at screening.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Unable to refrain from using foods and beverages containing alcohol for at least 24 hours before each IMP dosing and throughout the inpatient period.
- The participant has poor peripheral venous access.
- Participants who, in the opinion of the investigator, should not participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Veritus Research
Bayswater, Victoria, 3153
About this study
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
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
- Being tested
- Forsteo®, B-3E07
- Keywords
- Crossover, Pharmacokinetics, Immunogenicity, Bio similarity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forsteo®Biological
Forsteo® will be administered as SC injection.
B-3E07Biological
B-3E07 will be administered as SC injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Forsteo®; Biological: B-3E07 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax) of B-3E07
Measured: 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
Measured: Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose
Cmax of Forsteo®
Measured: Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose
AUC 0-inf of Forsteo®
Measured: 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®
Measured: 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®
Measured: 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®
Measured: 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®
Measured: 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®
Measured: 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®
Measured: 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®
Measured: 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®
Measured: 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)
Measured: From baseline up to End of Study (EOS)/ Early termination (ET) (up to 53 days)
Number of Participants With Injection Site Reactions
Measured: 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
Measured: 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®
Measured: Baseline up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start10 Apr 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion14 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syneos Health
- Sponsor type
- University, hospital or other
- Collaborators
- Yifan Pharmaceutical (Shanghai) Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497503
- Sponsor's protocol ID
- YF-B07-001
- Status last verified
- Jul 2026
- First submitted
- 23 Mar 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07497503
- Acronym / sponsor ID
- YF-B07-001
- Conditions
- Healthy Volunteers
- Keywords
- Crossover, Pharmacokinetics, Immunogenicity, Bio similarity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Syneos HealthUniversity, hospital or other
- Collaborators
- Yifan Pharmaceutical (Shanghai) Co., Ltd.
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 14 Oct 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: B-3E07 Followed by Forsteo ® | Experimental | Biological: Forsteo®, Biological: B-3E07Participants 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. |
| Sequence 2: Forsteo® Followed by B-3E07 | Active comparator | Biological: Forsteo®, Biological: B-3E07Participants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forsteo®Forsteo® will be administered as SC injection. | Biological | Sequence 1: B-3E07 Followed by Forsteo ®, Sequence 2: Forsteo® Followed by B-3E07 |
| B-3E07B-3E07 will be administered as SC injection. | Biological | Sequence 1: B-3E07 Followed by Forsteo ®, Sequence 2: Forsteo® Followed by B-3E07 |
Primary outcome
Maximum Plasma Concentration (Cmax) of B-3E07
Time frame: 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
Time frame: Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose
Cmax of Forsteo®
Time frame: Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose
AUC 0-inf of Forsteo®
Time frame: Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose
12 secondary outcomes
Area Under the Plasma Concentration-time Curve up to Time t (AUC 0-t) of B-3E07 and Forsteo®
Time frame: 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®
Time frame: 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®
Time frame: 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®
Time frame: 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®
Time frame: 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®
Time frame: 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®
Time frame: 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®
Time frame: 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)
Time frame: From baseline up to End of Study (EOS)/ Early termination (ET) (up to 53 days)
Number of Participants With Injection Site Reactions
Time frame: 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
Time frame: 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®
Time frame: Baseline up to 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Forsteo® and B-3E07 in people with Healthy Volunteers, run by Syneos Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Benjamin Snyder, MBBS, FRACP (613 8736 1750, bensnyder@veritusresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) of B-3E07 (time frame: Treatment Periods 1 and 2: Day 1 - Pre-dose and up to 6 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.