First in Man Clinical Study to Investigate Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of CM3.1-AC100

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-05-31

Brief Summary

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A first time in man, phase I study to assess the safety, tolerability and pharmacokinetics of single ascending doses of CM3.1-AC100 in healthy male volunteers.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CM3.1-AC100

Group Type EXPERIMENTAL

CM3.1-AC100

Intervention Type DRUG

Solution for sc injection, single ascending doses

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Solution for sc injection

Interventions

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CM3.1-AC100

Solution for sc injection, single ascending doses

Intervention Type DRUG

Placebo

Solution for sc injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Provision of signed and dated informed consent prior to any study specific procedures
* Body weight between 60.0 to 100.0 kg (both inclusive) and BMI 19 to 29.9 kg/m2 (both inclusive)
* Judged as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination)

Exclusion Criteria

* Any history or presence of a clinically relevant disease as judged to be relevant by the Investigator
* Blood donation within 3 month before administration of the IP
* Have a history of hypersensitivity to the IP or any of the excipients or to medicinal products with similar chemical structures

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes