NCT01028521

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

July 15, 2010

Status Verified

July 1, 2010

Enrollment Period

3 months

First QC Date

December 2, 2009

Last Update Submit

July 14, 2010

Conditions

Healthy

Keywords

First time in man, safety study, Cm3.1-AC100Male volunteer aged 18 to 50 years at Screening

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

CM3.1-AC100

EXPERIMENTAL
Drug: CM3.1-AC100

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

CM3.1-AC100DRUG

Solution for sc injection, single ascending doses

CM3.1-AC100
PlaceboDRUG

Solution for sc injection

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parexel International GmbH

Berlin, State of Berlin, 14050, Germany

Location

Study Officials

  • Peter Geigle, Dr. med.

    CellMed AG, a subsidiary of BTG plc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 2, 2009

First Posted

December 9, 2009

Study Start

February 1, 2010

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

July 15, 2010

Record last verified: 2010-07

Locations

DE(1)