Safety, Pharmacokinetic and Pharmacodynamic Study of COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide (COR-1-01)
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
COR-1
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring anti-beta1 adrenergic receptor, autoantibody, cyclic peptide, heart failure
Eligibility 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
Sites / Locations
- ABX-CRO
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
COR-1
placebo
Arm Description
single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1
intravenous 0.9 % NaCl
Outcomes
Primary Outcome Measures
The Number of Participants Reporting Adverse Events (AEs)
To assess the safety and tolerability of COR-1.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01043146
Brief Title
Safety, Pharmacokinetic and Pharmacodynamic Study of COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide
Acronym
COR-1-01
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 Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Corimmun GmbH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
anti-beta1 adrenergic receptor, autoantibody, cyclic peptide, heart failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COR-1
Arm Type
Active Comparator
Arm Description
single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
intravenous 0.9 % NaCl
Intervention Type
Drug
Intervention Name(s)
COR-1
Other Intervention Name(s)
cyclic peptide
Intervention Description
single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
intravenous 0.9 % NaCl
Primary Outcome Measure Information:
Title
The Number of Participants Reporting Adverse Events (AEs)
Description
To assess the safety and tolerability of COR-1.
Time Frame
45 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariola Lappo, MD
Organizational Affiliation
ABX CRO
Official's Role
Principal Investigator
Facility Information:
Facility Name
ABX-CRO
City
Goerlitz
State/Province
Saxonia
ZIP/Postal Code
02826
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
22968742
Citation
Munch G, Boivin-Jahns V, Holthoff HP, Adler K, Lappo M, Truol S, Degen H, Steiger N, Lohse MJ, Jahns R, Ungerer M. Administration of the cyclic peptide COR-1 in humans (phase I study): ex vivo measurements of anti-beta1-adrenergic receptor antibody neutralization and of immune parameters. Eur J Heart Fail. 2012 Nov;14(11):1230-9. doi: 10.1093/eurjhf/hfs118. Epub 2012 Sep 11. Erratum In: Eur J Heart Fail. 2013 Apr;15(4):478. Dosage error in article text.
Results Reference
derived
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Safety, Pharmacokinetic and Pharmacodynamic Study of COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide
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