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Recruiting NCT07497503

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

Conditions: Healthy Volunteers

Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 48
Sponsor: Syneos Health

Location: Veritus Research Bayswater Victoria

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.

Eligibility Criteria

Inclusion Criteria: 1. Healthy adult Caucasian female volunteers, 18-45 years of age, inclusive, at the time of consent. 2. Body Mass Index (BMI) greater than (\>)18.5 and less 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 \=50 mmHg and \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07497503). StuddyBuddy aggregates publicly available trial information.