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

This study has been completed.
Information provided by:
CellMed AG, a subsidiary of BTG plc. Identifier:
First received: December 2, 2009
Last updated: July 14, 2010
Last verified: July 2010

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.

Condition Intervention Phase
Drug: CM3.1-AC100
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by CellMed AG, a subsidiary of BTG plc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 56
Study Start Date: February 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CM3.1-AC100 Drug: CM3.1-AC100
Solution for sc injection, single ascending doses
Placebo Comparator: Placebo Drug: Placebo
Solution for sc injection


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts 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
  Contacts and Locations
Please refer to this study by its identifier: NCT01028521

Parexel International GmbH
Berlin, Germany, 14050
Sponsors and Collaborators
CellMed AG, a subsidiary of BTG plc.
Study Chair: Peter Geigle, Dr. med. CellMed AG, a subsidiary of BTG plc.
  More Information

No publications provided

Responsible Party: Dr. Peter Geigle, Cellmed AG Identifier: NCT01028521     History of Changes
Other Study ID Numbers: CellMed CM3.1-AC100/01, EudraCT No. 2009-017344-13
Study First Received: December 2, 2009
Last Updated: July 14, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by CellMed AG, a subsidiary of BTG plc.:
First time in man, safety study, Cm3.1-AC100
Male volunteer aged 18 to 50 years at Screening processed this record on April 17, 2014