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

Phase 1

Completed

• Conditions: Heart Failure
• Interventions: Drug: COR-1; Drug: placebo

• Registration Number: NCT01043146
• Lead Sponsor: Corimmun GmbH

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.

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Study First Submitted: 2010-01-05
• Study First Submitted QC: 2010-01-05
• Study First Posted: 2010-01-06
• Results First Submitted: 2012-10-26
• Status Verified: 2013-03
• Results First Submitted QC: 2013-03-05
• Last Update Submitted: 2013-03-05
• Results First Posted: 2013-04-08
• Last Update Posted: 2013-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COR-1	COR-1	single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1
placebo	placebo	intravenous 0.9 % NaCl

Primary Outcome Measures

Name	Time	Method
The Number of Participants Reporting Adverse Events (AEs)	45 days	To assess the safety and tolerability of COR-1.

Trial Locations

Locations (1)

ABX-CRO; 🇩🇪 Goerlitz, Saxonia, Germany