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Completed

NCT Number: NCT01028521

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

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.

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International GmbH

Berlin, State of Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CM3.1-AC100

Drug

Solution for sc injection, single ascending doses

Placebo

Drug

Solution for sc injection

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

CellMed AG, a subsidiary of BTG plc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 9, 2009
Registry last updated
Jul 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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