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

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

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• 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;
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo for compound CM3.1-AC100 s.c.	Drug: Placebo; Placebo for compound CM3.1-AC100 s.c.
Experimental: CM3.1-AC100; Compound CM3.1-AC100 s.c.	Drug: CM3.1-AC100; MAD study with repeated subcutaneous (sc) 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 Intensity, anti- CM3.1-AC100 antibodies)	Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic samples for CM3.1-AC100	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.	Intense PK-sampling during the 15 hours following administration of CM3.1-AC100 during day 1 and day 7

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: July 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: July 16, 2010
• First Submitted That Met QC Criteria: July 19, 2010
• First Posted (Estimate): July 20, 2010

Study Record Updates

• Last Update Posted (Estimate): January 19, 2011
• Last Update Submitted That Met QC Criteria: January 18, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: MAD study CM3.1-AC100; Healthy men, age 18 - 50
• Other Study ID Numbers: CellMed CM3.1-AC100/02; 2010-020512-11 (EudraCT Number)