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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: CM3.1-AC100; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • Parexel International GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety measurements (Adverse events, ECG recordings, blood pressure, pulse, body temperature, laboratory variables,local tolerability, nausea questionnaire)	Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study

Collaborators and Investigators

• Sponsor: CellMed AG, a subsidiary of BTG plc.
• Investigators: Study Chair: Peter Geigle, Dr. med., CellMed AG, a subsidiary of BTG plc.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: December 2, 2009
• First Submitted That Met QC Criteria: December 8, 2009
• First Posted (Estimate): December 9, 2009

Study Record Updates

• Last Update Posted (Estimate): July 15, 2010
• Last Update Submitted That Met QC Criteria: July 14, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: First time in man, safety study, Cm3.1-AC100; Male volunteer aged 18 to 50 years at Screening
• Other Study ID Numbers: CellMed CM3.1-AC100/01; EudraCT No. 2009-017344-13 (Registry Identifier: EudraCT)