First in Man Clinical Study to Investigate Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of CM3.1-AC100
- Registration Number
- NCT01028521
- Lead Sponsor
- CellMed AG, a subsidiary of BTG plc.
- Brief Summary
A first time in man, phase I study to assess the safety, tolerability and pharmacokinetics of single ascending doses of CM3.1-AC100 in healthy male volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 56
Inclusion Criteria
- Provision of signed and dated informed consent prior to any study specific procedures
- Body weight between 60.0 to 100.0 kg (both inclusive) and BMI 19 to 29.9 kg/m2 (both inclusive)
- Judged as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination)
Exclusion Criteria
- Any history or presence of a clinically relevant disease as judged to be relevant by the Investigator
- Blood donation within 3 month before administration of the IP
- Have a history of hypersensitivity to the IP or any of the excipients or to medicinal products with similar chemical structures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CM3.1-AC100 CM3.1-AC100 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Safety measurements (Adverse events, ECG recordings, blood pressure, pulse, body temperature, laboratory variables,local tolerability, nausea questionnaire) Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Parexel International GmbH
🇩🇪Berlin, Germany