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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:
Information provided by:
CellMed AG, a subsidiary of BTG plc.
ClinicalTrials.gov Identifier:
NCT01028521
First received: December 2, 2009
Last updated: July 14, 2010
Last verified: July 2010
  Purpose

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
Healthy
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028521

Locations
Germany
Parexel International GmbH
Berlin, Germany, 14050
Sponsors and Collaborators
CellMed AG, a subsidiary of BTG plc.
Investigators
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
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on November 27, 2014