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

ConditionHealthy Volunteers

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexFemale

Age18-45

SponsorSyneos Health

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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/m²) (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).

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

Forsteo®
Biological/Vaccine
Forsteo® will be administered as SC injection.
B-3E07
Biological/Vaccine
B-3E07 will be administered as SC injection.

Treatment groups

48 Participants

are divided into 2 treatment groups

Group A: Sequence 1: B-3E07 Followed by Forsteo ®Experimental treatment 2 interventions

Group B: Sequence 2: Forsteo® Followed by B-3E07Active comparator 2 interventions