NCT01043146

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 heart-failure

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_1 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

April 8, 2013

Completed
Last Updated

April 8, 2013

Status Verified

March 1, 2013

Enrollment Period

3 months

First QC Date

January 5, 2010

Results QC Date

October 26, 2012

Last Update Submit

March 5, 2013

Conditions

Heart Failure

Keywords

anti-beta1 adrenergic receptorautoantibodycyclic peptideheart failure

Outcome Measures

Primary Outcomes (1)

  • The Number of Participants Reporting Adverse Events (AEs)

    To assess the safety and tolerability of COR-1.

    45 days

Study Arms (2)

COR-1

ACTIVE COMPARATOR

single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1

Drug: COR-1

placebo

PLACEBO COMPARATOR

intravenous 0.9 % NaCl

Drug: placebo

Interventions

COR-1DRUG

single intravenous administration of 10, 40, 80, 160 or 240 mg of COR-1

Also known as: cyclic peptide
COR-1
placeboDRUG

intravenous 0.9 % NaCl

placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Autoimmune disorders
  • Kidney diseases
  • Liver diseases, liver function impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ABX-CRO

Görlitz, Saxony, 02826, Germany

Location

Related Publications (1)

  • 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.

    PMID: 22968742DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Peptides, Cyclic

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Macrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Gary Peters, MD, Managing Director
Organization
Corimmun, GmbH
gpeters7@its.jnj.com
001-215 628-5257

Study Officials

  • Mariola Lappo, MD

    ABX CRO

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 6, 2010

Study Start

October 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

April 8, 2013

Results First Posted

April 8, 2013

Record last verified: 2013-03

Locations

DE(1)