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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corimmun GmbH
ClinicalTrials.gov Identifier:
NCT01043146
First received: January 5, 2010
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Heart Failure
Drug: COR-1
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Corimmun GmbH:

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


Enrollment: 50
Study Start Date: October 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043146

Locations
Germany
ABX-CRO
Goerlitz, Saxonia, Germany, 02826
Sponsors and Collaborators
Corimmun GmbH
Investigators
Principal Investigator: Mariola Lappo, MD ABX-CRO
  More Information

No publications provided by Corimmun GmbH

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Corimmun GmbH
ClinicalTrials.gov Identifier: NCT01043146     History of Changes
Other Study ID Numbers: COR-1-01, EudraCT2008-007745-31
Study First Received: January 5, 2010
Results First Received: October 26, 2012
Last Updated: March 5, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Corimmun GmbH:
anti-beta1 adrenergic receptor
autoantibody
cyclic peptide
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 09, 2014