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Safety, Pharmacokinetic and Pharmacodynamic Study of COR-1, an Anti-ß1 Receptor Antibody Cyclopeptide (COR-1-01)

C

Corimmun

Status and phase

Completed
Phase 1

Conditions

Heart Failure

Treatments

Drug: COR-1
Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01043146
EudraCT2008-007745-31 (Registry Identifier)
COR-1-01

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups, including a placebo group

COR-1
Active Comparator group
Description:
single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1
Treatment:
Drug: COR-1
placebo
Placebo Comparator group
Description:
intravenous 0.9 % NaCl
Treatment:
Drug: placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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