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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CM3.1-AC100; Drug: Placebo

• Registration Number: NCT01165502
• Lead Sponsor: CellMed AG, a subsidiary of BTG plc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-16
• Study First Submitted QC: 2010-07-19
• Study First Posted: 2010-07-20
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-18
• Last Update Posted: 2011-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CM3.1-AC100	CM3.1-AC100	Compound CM3.1-AC100 s.c.
Placebo	Placebo	Placebo for compound CM3.1-AC100 s.c.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	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.

Trial Locations

Locations (1)

Parexel International GmbH; 🇩🇪 Berlin, Germany