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

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ClinicalTrials.gov Identifier: NCT01028521
Recruitment Status : Completed
First Posted : December 9, 2009
Last Update Posted : July 15, 2010
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: CM3.1-AC100 Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : February 2010
Primary Completion Date : May 2010
Study Completion Date : May 2010
Arms and Interventions

Arm Intervention/treatment
Experimental: CM3.1-AC100 Drug: CM3.1-AC100
Solution for sc injection, single ascending doses
Placebo Comparator: Placebo Drug: Placebo
Solution for sc injection

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Peter Geigle, Cellmed AG
ClinicalTrials.gov Identifier: NCT01028521     History of Changes
Other Study ID Numbers: CellMed CM3.1-AC100/01
EudraCT No. 2009-017344-13 ( Registry Identifier: EudraCT )
First Posted: December 9, 2009    Key Record Dates
Last Update Posted: July 15, 2010
Last Verified: July 2010

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