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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
40
MAD study with repeated subcutaneous (sc) doses
Placebo for compound CM3.1-AC100 s.c.
Parexel International GmbH
Berlin, State of Berlin, Germany
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
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.
Time frame: Intense PK-sampling during the 15 hours following administration of CM3.1-AC100 during day 1 and day 7
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