Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Multiple Ascending Doses of CM3.1-AC100 in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by:
CellMed AG, a subsidiary of BTG plc.
ClinicalTrials.gov Identifier:
NCT01165502
First received: July 16, 2010
Last updated: January 18, 2011
Last verified: January 2011
  Purpose

The primary objective is to assess the safety and tolerability of the GLP-1 peptide analogue CM3.1-AC100 after repeated subcutaneous (sc) doses.


Condition Intervention Phase
Healthy
Drug: CM3.1-AC100
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Official Title: Single-centre, Randomised, Double-blind, Placebo-controlled Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Multiple 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 Intensity, anti- CM3.1-AC100 antibodies) [ 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 ]

Secondary Outcome Measures:
  • Pharmacokinetic samples for CM3.1-AC100 [ Time Frame: Intense PK-sampling during the 15 hours following administration of CM3.1-AC100 during day 1 and day 7 ] [ Designated as safety issue: No ]

    Pharmacokinetics:

    Following the first dosing on Day 1:

    AUC, AUC0-t, AUC0-9h, Cmax, tmax, t1/2λz, λz, CL/F, Vz/F of CM3.1-AC100.

    Following multiple dosing on Day 7:

    AUCss, AUCss,0-t, AUCss,0-9h, Css,max, Css, min, tss,max, t1/2λz,ss, λz,ss, CLss/F, Vz,ss/F, of CM3.1-AC100.



Estimated Enrollment: 40
Study Start Date: July 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CM3.1-AC100
Compound CM3.1-AC100 s.c.
Drug: CM3.1-AC100
MAD study with repeated subcutaneous (sc) doses
Placebo Comparator: Placebo
Placebo for compound CM3.1-AC100 s.c.
Drug: Placebo
Placebo for compound CM3.1-AC100 s.c.

  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;
  • Male volunteer aged 18 to 50 years at Screening, both inclusive;
  • Body weight between 60.0 to 100.0 kg (both inclusive) and BMI 19 to 29.9 kg/m2 (both inclusive)

Exclusion Criteria:

  • Any history or presence of a clinically relevant disease as judged to be relevant by the Investigator: cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, ocular or infectious disease and any acute infectious disease or signs of acute illness;
  • Blood donation within 3 month before administration of the IP;
  • Presence or history of drug allergy, or allergic disease diagnosed and treated by a physician
  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: NCT01165502

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: NCT01165502     History of Changes
Other Study ID Numbers: CellMed CM3.1-AC100/02, 2010-020512-11
Study First Received: July 16, 2010
Last Updated: January 18, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by CellMed AG, a subsidiary of BTG plc.:
MAD study CM3.1-AC100
Healthy men, age 18 - 50

ClinicalTrials.gov processed this record on September 16, 2014