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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT2008-007745-31 | Registry Identifier | EudraCT |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COR-1 | Active Comparator | single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1 |
|
| placebo | Placebo Comparator | intravenous 0.9 % NaCl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COR-1 | Drug | single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Reporting Adverse Events (AEs) | To assess the safety and tolerability of COR-1. | 45 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mariola Lappo, MD | ABX CRO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ABX-CRO | Görlitz | Saxony | 02826 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22968742 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | intravenous 0.9 % NaCl |
| FG001 | 10 mg COR-1 | single intravenous administration |
| FG002 | 40 mg COR-1 | single intravenous administration |
| FG003 | 80 mg COR-1 | single intravenous administration |
| FG004 | 160 mg COR-1 | single intravenous administration |
| FG005 | 240 mg COR-1 | single intravenous administration |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | intravenous 0.9 % NaCl |
| BG001 | 10 mg COR-1 | single intravenous administration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants Reporting Adverse Events (AEs) | To assess the safety and tolerability of COR-1. | Posted | Number | Participants | 45 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | intravenous 0.9 % NaCl |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| not drug-related traumatic injury (achilles tendon) during sledging 8600 half-lives post drug admin. | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| feeling of cold at infusion site when drug was added to cold saline solution | General disorders | Non-systematic Assessment | Caused by cold temperature of infusion solution. The event never reoccurred when solution was equilibrated to room temperature prior to injection. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Peters, MD, Managing Director | Corimmun, GmbH | 001-215 628-5257 | gpeters7@its.jnj.com |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| ID | Term |
|---|---|
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| placebo | Drug | intravenous 0.9 % NaCl |
|
| BG002 |
| 40 mg COR-1 |
single intravenous administration |
| BG003 | 80 mg COR-1 | single intravenous administration |
| BG004 | 160 mg COR-1 | single intravenous administration |
| BG005 | 240 mg COR-1 | single intravenous administration |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 80 mg COR-1 |
single intravenous administration |
| OG004 | 160 mg COR-1 | single intravenous administration |
| OG005 | 240 mg COR-1 | single intravenous administration |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 10 mg COR-1 | single intravenous administration | 0 | 8 | 0 | 8 |
| EG002 | 40 mg COR-1 | single intravenous administration | 0 | 8 | 3 | 8 |
| EG003 | 80 mg COR-1 | single intravenous administration | 0 | 8 | 0 | 8 |
| EG004 | 160 mg COR-1 | single intravenous administration | 0 | 8 | 0 | 8 |
| EG005 | 240 mg COR-1 | single intravenous administration | 1 | 8 | 0 | 8 |
Injury by sheet metal used for tobogganing 18 days after drug administration. Hospitalisation for 3 days (2 nights). Plastic reconstruction of the Achilles tendon, antibiotic treatment and wound dressing. Ambulatory follow up 31 days later.
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The PI can discuss and publish trial results upon review of results communication by the sponsor. The sponsor can require changes to the communication.