Skip to main content
OpenTrials
Completed

NCT Number: NCT01165502

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

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

Completed

Looking for future studies?

Notify Me

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;
  • 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

Treatment and study plan

CM3.1-AC100

Drug

MAD study with repeated subcutaneous (sc) doses

Placebo

Drug

Placebo for compound CM3.1-AC100 s.c.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    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.

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 Multiple Ascending Doses of CM3.1-AC100 in Healthy Male Volunteers

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 20, 2010
Registry last updated
Jan 19, 2011

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.