Heart Failure
Conditions
Keywords
anti-beta1 adrenergic receptor, autoantibody, cyclic peptide, heart failure
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.
Interventions
DRUGCOR-1
single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1
DRUGplacebo
intravenous 0.9 % NaCl
Sponsors
Corimmun GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants Reporting Adverse Events (AEs) | 45 days | To assess the safety and tolerability of COR-1. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo intravenous 0.9 % NaCl | 10 |
| 10 mg COR-1 single intravenous administration | 8 |
| 40 mg COR-1 single intravenous administration | 8 |
| 80 mg COR-1 single intravenous administration | 8 |
| 160 mg COR-1 single intravenous administration | 8 |
| 240 mg COR-1 single intravenous administration | 8 |
| Total | 50 |
Baseline characteristics
| Characteristic | 10 mg COR-1 | 40 mg COR-1 | 80 mg COR-1 | 160 mg COR-1 | 240 mg COR-1 | Placebo | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 10 Participants | 50 Participants |
| Age Continuous | 32.5 years STANDARD_DEVIATION 7.09 | 33.1 years STANDARD_DEVIATION 8.94 | 31.9 years STANDARD_DEVIATION 7.77 | 30.1 years STANDARD_DEVIATION 8.66 | 27.5 years STANDARD_DEVIATION 8.35 | 34.1 years STANDARD_DEVIATION 8.61 | 31.6 years STANDARD_DEVIATION 8.15 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 8 Participants | 10 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 8 | 3 / 8 | 0 / 8 | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 10 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 8 | 1 / 8 |
Outcome results
Primary
The Number of Participants Reporting Adverse Events (AEs)
To assess the safety and tolerability of COR-1.
Time frame: 45 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | The Number of Participants Reporting Adverse Events (AEs) | AE | 0 Participants |
| Placebo | The Number of Participants Reporting Adverse Events (AEs) | SAE | 0 Participants |
| 10 mg COR-1 | The Number of Participants Reporting Adverse Events (AEs) | AE | 0 Participants |
| 10 mg COR-1 | The Number of Participants Reporting Adverse Events (AEs) | SAE | 0 Participants |
| 40 mg COR-1 | The Number of Participants Reporting Adverse Events (AEs) | AE | 3 Participants |
| 40 mg COR-1 | The Number of Participants Reporting Adverse Events (AEs) | SAE | 0 Participants |
| 80 mg COR-1 | The Number of Participants Reporting Adverse Events (AEs) | AE | 0 Participants |
| 80 mg COR-1 | The Number of Participants Reporting Adverse Events (AEs) | SAE | 0 Participants |
| 160 mg COR-1 | The Number of Participants Reporting Adverse Events (AEs) | AE | 0 Participants |
| 160 mg COR-1 | The Number of Participants Reporting Adverse Events (AEs) | SAE | 0 Participants |
| 240 mg COR-1 | The Number of Participants Reporting Adverse Events (AEs) | AE | 0 Participants |
| 240 mg COR-1 | The Number of Participants Reporting Adverse Events (AEs) | SAE | 1 Participants |