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Clinical Trials/NCT01028521
NCT01028521
Completed
Phase 1

Single-centre, Randomised, Double-blind, Placebo-controlled Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Single Ascending Doses of CM3.1-AC100 in Healthy Male Volunteers

CellMed AG, a subsidiary of BTG plc.1 site in 1 country56 target enrollmentFebruary 2010
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ConditionsHealthy
InterventionsPlaceboCM3.1-AC100
DrugsCM3.1-AC100Placebo

Overview

Phase
Phase 1
Intervention
Placebo
Conditions
Healthy
Sponsor
CellMed AG, a subsidiary of BTG plc.
Enrollment
56
Locations
1
Primary Endpoint
Safety measurements (Adverse events, ECG recordings, blood pressure, pulse, body temperature, laboratory variables,local tolerability, nausea questionnaire)
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
May 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
CellMed AG, a subsidiary of BTG plc.

Eligibility Criteria

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

Arms & Interventions

Placebo

Intervention: Placebo

CM3.1-AC100

Intervention: CM3.1-AC100

Outcomes

Primary Outcomes

Safety measurements (Adverse events, ECG recordings, blood pressure, pulse, body temperature, laboratory variables,local tolerability, nausea questionnaire)

Time Frame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study

Study Sites (1)

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