NL-OMON41949CompletedNot Applicable
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
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
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
Investigators
Similar Trials
Completed
Phase 1
Assessment of the safety and distribution of NVB302 in healthy volunteersClostridium difficile infectionInfections and InfestationsISRCTN40071144ovacta Biosystems Limited (UK)72
Active, not recruiting
Not Applicable
A study to evaluate reactogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated liquid human rotavirus (HRV) vaccine 444563, in healthy infants.EUCTR2012-001481-16-Outside-EU/EEAGlaxoSmithKline Biologicals50
Completed
Phase 1
HIVIS07: A phase I trial to assess the safety and immunogenicity of a plasmid DNA-MVA prime boost HIV-1 vaccine candidate administered together with dermal electroporation among volunteers in Stockholm, SwedeHIVInfections and InfestationsHuman immunodeficiency virus [HIV] diseaseISRCTN60284968Swedish Institute for Infectious Disease Control (SMI) (Sweden)48
Completed
Not Applicable
A Phase I, double-blind, randomised, placebo-controlled, multiple dose study to evaluate the safety, pharmacokinetics and pharmacodynamics of two dosages of estetrol in healthy meProstate cancerNL-OMON43503Pantarhei Oncology45
Recruiting
Phase 1
A Phase I, double-blind, randomised, placebo-controlled, single-ascending and multiple-ascending dose trial to evaluate the safety and pharmacokinetics of oral controlled-ileal-release nicotinic acid (CIR-NA) compared to immediate-release nicotinic acid and placebo in healthy subjects and subjects with prediabetesThis is a phase I clinical trial which includes only healthy subjects and subjects with prediabetes.DRKS00030865niversitätsklinikum Schleswig-Holstein, Campus Kiel66
