A phase I, double-blind, randomised, placebo-controlled study, in three parts (parts A, B and C) to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of BIM23B065 administered subcutaneously as single and multiple ascending doses to young healthy male subjects
Completed
- Conditions
- acromegalygigantism.10021112
- Registration Number
- NL-OMON41949
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
Inclusion Criteria
- healthy male subjects
- 18-45 yrs, inclusive
- BMI: 19-30 kg/m2, inclusive
- Provision of written informed consent
Exclusion Criteria
Any clinically significant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study. Positive test at screening of any of the following: Hepatitis B, Hepatitis C or human immunodeficiency virus/AIDS, History of cholelithiasis, or detected at screening gallbladder echography
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety: Incidence and severity of adverse events, laboratory abnormalities,<br /><br>changes in ECGs and Vital signs</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacokinetic characteristics of BIM23B065 and pharmacodynamic markers<br /><br>profile (Growth Hormone cycle, Prolactin cycle and Insulin like growth factor-1<br /><br>levels).</p><br>