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

NCT ID: NCT01043146

Last Updated: 2013-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-01-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

COR-1

single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1

Group Type: ACTIVE_COMPARATOR

COR-1

Intervention Type: DRUG

single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1

placebo

intravenous 0.9 % NaCl

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

intravenous 0.9 % NaCl

Interventions

COR-1

single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1

Intervention Type: DRUG

placebo

intravenous 0.9 % NaCl

Intervention Type: DRUG

Other Intervention Names

cyclic peptide

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Corimmun GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mariola Lappo, MD

Role: PRINCIPAL_INVESTIGATOR

ABX CRO

Locations

ABX-CRO

Görlitz, Saxony, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 22968742 (View on PubMed)

Other Identifiers

EudraCT2008-007745-31

Identifier Type: REGISTRY

Identifier Source: secondary_id

COR-1-01

Identifier Type: -

Identifier Source: org_study_id