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Official title A Study of B-3E07 and Forsteo® in Healthy Adult Female Participants
ClinicalTrials.gov ID: NCT07497503
What this study is testing
What is Forsteo®?
Forsteo® is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for healthy volunteers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join 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...
- 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...
- Absence of tattoos, scars, or any skin conditions, including infections or open wounds, or dermatitis at the injection site that could interfere with...
You likely can't join 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...
- 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...
- 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...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bayswater, Victoria, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bayswater, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.