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First in Man Clinical Study to Investigate Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of CM3.1-AC100

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01028521
First Posted: December 9, 2009
Last Update Posted: July 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
CellMed AG, a subsidiary of BTG plc.
December 2, 2009
December 9, 2009
July 15, 2010
February 2010
May 2010   (Final data collection date for primary outcome measure)
Safety measurements (Adverse events, ECG recordings, blood pressure, pulse, body temperature, laboratory variables,local tolerability, nausea questionnaire) [ Time Frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study ]
Same as current
Complete list of historical versions of study NCT01028521 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
First in Man Clinical Study to Investigate Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of CM3.1-AC100
Single-centre, Randomised, Double-blind, Placebo-controlled Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Single Ascending Doses of CM3.1-AC100 in Healthy Male Volunteers
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: CM3.1-AC100
    Solution for sc injection, single ascending doses
  • Drug: Placebo
    Solution for sc injection
  • Experimental: CM3.1-AC100
    Intervention: Drug: CM3.1-AC100
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
May 2010
May 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01028521
CellMed CM3.1-AC100/01
EudraCT No. 2009-017344-13 ( Registry Identifier: EudraCT )
No
Not Provided
Not Provided
Dr. Peter Geigle, Cellmed AG
CellMed AG, a subsidiary of BTG plc.
Not Provided
Study Chair: Peter Geigle, Dr. med. CellMed AG, a subsidiary of BTG plc.
CellMed AG, a subsidiary of BTG plc.
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP