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OpenTrials
Completed

NCT Number: NCT01043146

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

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

Completed

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

ABX-CRO

Görlitz, Saxony, 02826, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COR-1

Drug

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

Other names: cyclic peptide

Placebo

Drug

intravenous 0.9 % NaCl

Primary outcomes

  1. The Number of Participants Reporting Adverse Events (AEs)

    Time frame: 45 days

    To assess the safety and tolerability of COR-1.

Sponsors and collaborators

Lead sponsor

Corimmun GmbH

Industry

Registry information

Official study 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

Acronym: COR-1-01

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 6, 2010
Registry last updated
Apr 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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