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

CellMed

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: CM3.1-AC100

Study type: Interventional

Funder types: Industry

Identifiers

NCT01028521

CellMed CM3.1-AC100/01

EudraCT No. 2009-017344-13 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 56 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
• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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56 participants in 2 patient groups, including a placebo group

CM3.1-AC100

Experimental group

Treatment:

Drug: CM3.1-AC100

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo