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

• Sponsor: Corimmun GmbH (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01043146
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 16.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Drug: COR-1; Drug: placebo	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official 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
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: COR-1 single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1	Drug: COR-1; single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1; Other Names: cyclic peptide
Placebo Comparator: placebo intravenous 0.9 % NaCl	Drug: placebo; intravenous 0.9 % NaCl

Outcome Measures

Primary Outcome Measures

1. The Number of Participants Reporting Adverse Events (AEs) [45 days]

   To assess the safety and tolerability of COR-1.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ABX-CRO	Goerlitz	Saxonia	Germany	02826

Sponsors and Collaborators

• Corimmun GmbH

Investigators

• Principal Investigator: Mariola Lappo, MD, ABX CRO

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Corimmun GmbH
• ClinicalTrials.gov Identifier: NCT01043146
• Other Study ID Numbers: COR-1-01; EudraCT2008-007745-31
• First Posted: Jan 6, 2010
• Last Update Posted: Apr 8, 2013
• Last Verified: Mar 1, 2013

• Keywords provided by Corimmun GmbH: anti-beta1 adrenergic receptor; autoantibody; cyclic peptide; heart failure
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

Arm/Group Title	Placebo	10 mg COR-1	40 mg COR-1	80 mg COR-1	160 mg COR-1	240 mg COR-1
Arm/Group Description	intravenous 0.9 % NaCl	single intravenous administration	single intravenous administration	single intravenous administration	single intravenous administration	single intravenous administration
Period Title: Overall Study
STARTED	10	8	8	8	8	8
COMPLETED	10	8	8	8	8	8
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Placebo	10 mg COR-1	40 mg COR-1	80 mg COR-1	160 mg COR-1	240 mg COR-1	Total
Arm/Group Description	intravenous 0.9 % NaCl	single intravenous administration	single intravenous administration	single intravenous administration	single intravenous administration	single intravenous administration	Total of all reporting groups
Overall Participants	10	8	8	8	8	8	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	8 100%	8 100%	8 100%	8 100%	8 100%	50 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.1 (8.61)	32.5 (7.09)	33.1 (8.94)	31.9 (7.77)	30.1 (8.66)	27.5 (8.35)	31.6 (8.15)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Male	10 100%	8 100%	8 100%	8 100%	8 100%	8 100%	50 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo	10 mg COR-1	40 mg COR-1	80 mg COR-1	160 mg COR-1	240 mg COR-1
Arm/Group Description	intravenous 0.9 % NaCl	single intravenous administration	single intravenous administration	single intravenous administration	single intravenous administration	single intravenous administration
Measure Participants	10	8	8	8	8	8
AE	0 0%	0 0%	3 37.5%	0 0%	0 0%	0 0%
SAE	0 0%	0 0%	0 0%	0 0%	0 0%	1 12.5%

Adverse Events

Arm/Group Title	Placebo		10 mg COR-1		40 mg COR-1		80 mg COR-1		160 mg COR-1		240 mg COR-1
Arm/Group Description	intravenous 0.9 % NaCl		single intravenous administration		single intravenous administration		single intravenous administration		single intravenous administration		single intravenous administration
All Cause Mortality
	Placebo		10 mg COR-1		40 mg COR-1		80 mg COR-1		160 mg COR-1		240 mg COR-1
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		10 mg COR-1		40 mg COR-1		80 mg COR-1		160 mg COR-1		240 mg COR-1
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/8 (0%)		0/8 (0%)		0/8 (0%)		0/8 (0%)		1/8 (12.5%)
Injury, poisoning and procedural complications
not drug-related traumatic injury (achilles tendon) during sledging 8600 half-lives post drug admin.	0/10 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0	1/8 (12.5%)	1
Other (Not Including Serious) Adverse Events
	Placebo		10 mg COR-1		40 mg COR-1		80 mg COR-1		160 mg COR-1		240 mg COR-1
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/8 (0%)		3/8 (37.5%)		0/8 (0%)		0/8 (0%)		0/8 (0%)
General disorders
feeling of cold at infusion site when drug was added to cold saline solution	0/10 (0%)	0	0/8 (0%)	0	3/8 (37.5%)	3	0/8 (0%)	0	0/8 (0%)	0	0/8 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The PI can discuss and publish trial results upon review of results communication by the sponsor. The sponsor can require changes to the communication.