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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
History of Changes
  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
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 May 16, 2013