Clinical trial NCT01043146: Safety, Pharmacokinetic and Pharmacodynamic Study of COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide
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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Failure
Keywords: anti-beta1 adrenergic receptor
autoantibody
cyclic peptide
heart failure
Lead sponsor: Corimmun GmbH
Sponsor class: INDUSTRY
First posted: 2010-01-06
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Number of Participants Reporting Adverse Events (AEs)
timeFrame: 45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Goerlitz
country: Germany
facility: ABX-CRO
state: Saxonia
Study officials:
affiliation: ABX CRO
name: Mariola Lappo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.