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

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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: CM3.1-AC100
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CM3.1-AC100<br>Compound CM3.1-AC100 s.c. | Drug: CM3.1-AC100<br>* MAD study with repeated subcutaneous (sc) doses<br>|
| Placebo Comparator: Placebo<br>Placebo for compound CM3.1-AC100 s.c. | Drug: Placebo<br>* Placebo for compound CM3.1-AC100 s.c.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MAD study CM3.1-AC100, Healthy men, age 18 - 50