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

CellMed

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: CM3.1-AC100

Study type

Interventional

Funder types

Industry

Identifiers

CellMed CM3.1-AC100/02

2010-020512-11 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment

40 estimated patients

Sex

Male

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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