Safety, Pharmacokinetic and Pharmacodynamic Study of COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide (COR-1-01)

March 5, 2013 updated by: Corimmun GmbH

A Single-Blind Placebo-Controlled Dose Escalating Safety and Pharmacokinetic Study of an Acute Intravenous Administration of Cor-1, An Anti-ß1 Receptor Antibody Cyclopeptide, in Five Different Strengths in Healthy Male Volunteers

Primary Trial objectives:

To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160, 240 mg) in 50 healthy, male volunteers after single intravenous administration (8 subjects on verum per dose level, 10 subjects receiving placebo)

Secondary objectives:

To evaluate safety and tolerability by using adverse events (AEs) and vital signs

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Trial objective:

To evaluate the pharmacokinetics and -dynamics of five strengths of COR-1 (10, 40, 80, 160, 240 mg) in healthy, male volunteers after single intravenous administration

Secondary objectives:

To evaluate safety and tolerability by using adverse events (AEs), vital signs including blood pressure/pulse rate (BP/PR), electrocardiographic examinations (12 lead ECG), evaluation of antibody titer and safety laboratory tests (biochemistry, hematology, coagulation, urinalysis)

Methodology:

Mono-center, single-blind, dose escalating study with five dose levels (8 subjects on verum per dose level, 2 subjects receiving placebo) in a total of 50 volunteers.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saxonia
      • Goerlitz, Saxonia, Germany, 02826
        • ABX-CRO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy, male Caucasians between 18 and 45 years of age, inclusive
  • Normotensive subjects (systolic BP <140 mmHg and diastolic BP <90 mmHg)
  • Body mass index (BMI) 19-27, minimal weight 60 kg
  • Negative results in HIV antibody, HBs antigen (HBsAg) and HCV tests, and negative result in anti-ß1-receptor-autoantibody screening
  • Signed Informed Consent Form
  • Normal or clinically irrelevant laboratory findings

Exclusion Criteria:

  • Autoimmune disorders
  • Kidney diseases
  • Liver diseases, liver function impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: COR-1
single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1
Drug: COR-1
single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1
Other Names:
  • cyclic peptide
PLACEBO_COMPARATOR: placebo
intravenous 0.9 % NaCl
Drug: placebo
intravenous 0.9 % NaCl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants Reporting Adverse Events (AEs)
Time Frame: 45 days
To assess the safety and tolerability of COR-1.
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corimmun GmbH

Investigators

  • Principal Investigator: Mariola Lappo, MD, ABX CRO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 5, 2010

First Posted (ESTIMATE)

January 6, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 8, 2013

Last Update Submitted That Met QC Criteria

March 5, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COR-1-01
  • EudraCT2008-007745-31 (REGISTRY: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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