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

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ClinicalTrials.gov Identifier: NCT01043146
Recruitment Status : Completed
First Posted : January 6, 2010
Results First Posted : April 8, 2013
Last Update Posted : April 8, 2013
Sponsor:
Information provided by (Responsible Party):
Corimmun GmbH

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment Phase
Heart Failure Drug: COR-1 Drug: placebo Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010
Arms and Interventions
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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 Name: cyclic peptide
Placebo Comparator: placebo
intravenous 0.9 % NaCl
 Drug: placebo
intravenous 0.9 % NaCl


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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01043146


Locations
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Germany
ABX-CRO
Goerlitz, Saxonia, Germany, 02826
Sponsors and Collaborators
Corimmun GmbH
Investigators
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Principal Investigator: Mariola Lappo, MD ABX CRO
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Corimmun GmbH
ClinicalTrials.gov Identifier: NCT01043146    
Other Study ID Numbers: COR-1-01
EudraCT2008-007745-31 ( Registry Identifier: EudraCT )
First Posted: January 6, 2010    Key Record Dates
Results First Posted: April 8, 2013
Last Update Posted: April 8, 2013
Last Verified: March 2013
Keywords provided by Corimmun GmbH:
anti-beta1 adrenergic receptor
autoantibody
cyclic peptide
heart failure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases