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

NCT01165502 | Completed Phase 1

• 2 other identifiers: CellMed CM3.1-AC100/022010-020512-11
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

MAD study CM3.1-AC100; Healthy men, age 18 - 50

Outcome Measures

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)

  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

  Intense PK-sampling during the 15 hours following administration of CM3.1-AC100 during day 1 and day 7

Study Arms (2)

CM3.1-AC100

EXPERIMENTAL

Compound CM3.1-AC100 s.c.

Drug: CM3.1-AC100

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

CM3.1-AC100 DRUG

MAD study with repeated subcutaneous (sc) doses

CM3.1-AC100

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• CellMed AG, a subsidiary of BTG plc.: lead

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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: July 20, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 19, 2011

Record last verified: 2011-01

Locations

DE (1)