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

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 - BIM23B065 in healthy volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41949

Enrollment

Registered

2015-12-03

Start date

2015-03-25

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acromegaly gigantism.

Interventions

Single or multiple doses of BIM23B065 or placebo.

acromegaly

dopamine

dopastatin

somatostatin

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - healthy male subjects - 18-45 yrs, inclusive - BMI: 19-30 kg/m2, inclusive - Provision of written informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Safety: Incidence and severity of adverse events, laboratory abnormalities, changes in ECGs and Vital signs	—

Secondary

Measure	Time frame
Pharmacokinetic characteristics of BIM23B065 and pharmacodynamic markers profile (Growth Hormone cycle, Prolactin cycle and Insulin like growth factor-1 levels).	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)