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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

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

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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

NCT ID

NCT01043146

First Posted

January 5, 2010

Last Updated

March 5, 2013

Sponsor

Corimmun GmbH

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

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

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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