Status:
COMPLETED
Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Multiple Ascending Doses of CM3.1-AC100 in Healthy Male Volunteers
Lead Sponsor:
CellMed AG, a subsidiary of BTG plc.
Conditions:
Healthy
Eligibility:
MALE
18-50 years
Phase:
PHASE1
Brief Summary
The primary objective is to assess the safety and tolerability of the GLP-1 peptide analogue CM3.1-AC100 after repeated subcutaneous (sc) doses.
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent prior to any study specific procedures;
- Male volunteer aged 18 to 50 years at Screening, both inclusive;
- Body weight between 60.0 to 100.0 kg (both inclusive) and BMI 19 to 29.9 kg/m2 (both inclusive)
Exclusion
- Any history or presence of a clinically relevant disease as judged to be relevant by the Investigator: cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, ocular or infectious disease and any acute infectious disease or signs of acute illness;
- Blood donation within 3 month before administration of the IP;
- Presence or history of drug allergy, or allergic disease diagnosed and treated by a physician
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01165502
Start Date
July 1 2010
End Date
November 1 2010
Last Update
January 19 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Parexel International GmbH
Berlin, State of Berlin, Germany, 14050