Healthy
Conditions
Keywords
First time in man, safety study, Cm3.1-AC100, Male volunteer aged 18 to 50 years at Screening
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.
Interventions
DRUGCM3.1-AC100
Solution for sc injection, single ascending doses
DRUGPlacebo
Solution for sc injection
Sponsors
CellMed AG, a subsidiary of BTG plc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany
Outcome results
None listed