Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetics of Cardiotrophin-1 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01334697
Recruitment Status : Unknown
Verified July 2013 by Digna Biotech S.L..
Recruitment status was:  Active, not recruiting
First Posted : April 13, 2011
Last Update Posted : July 30, 2013
Information provided by (Responsible Party):
Digna Biotech S.L.

Brief Summary:
The general aim of the study is to determinate safety, tolerability and early pharmacokinetics of cardiotrophin.1 in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: recombinant human cardiotrophin-1 Other: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Phase I, Randomized, Multicenter, Double-blind, Single Dose, Dose-Escalation, Placebo-Controlled, Parallel Group Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous Administration of Cardiotrophin-1 (CT-1)in Healthy Volunteers
Study Start Date : November 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Arm Intervention/treatment
Experimental: Cardiotrophin-1 Drug: recombinant human cardiotrophin-1
Single dose intravenous administration

Placebo Comparator: Placebo Other: Placebo
Single dose intravenous administration

Primary Outcome Measures :
  1. Number of participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: single dose administration (baseline) and 1 post-treatment follow up week ]
    Evaluate the tolerability and safety of single dose intravenous administration

Secondary Outcome Measures :
  1. Pharmacokinetic and Pharmacodynamic parameters [ Time Frame: single adminsitration (baseline) and 1 week of follow up ]

    Obtain pharmacokinetic parameters before and after CT-1 single dose administration.

    Analyze surrogated biological markers associated with CT-1 administration

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Male or Female, between the ages of 18 and 55.
  • Healthy condition (no suffering from known acute or chronic disease)
  • No clinically important abnormal physical or laboratory findings at the screening examination.
  • Normal or clinically acceptable ECG.
  • Normal blood pressure (systolic: 90-140 mmHg; diastolic: 50-90 mmHg) and heart rate (40-100 bpm).
  • Body Mass Index of 19.0-29.0 (kg/m2).
  • Ability to communicate well with the investigator and to comply with the requirements of the entire study.
  • Willingness to give written informed consent (prior to any study-related procedures being performed) and to be able to adhere to the study restrictions and examination schedule.
  • For female subjects with childbearing potential: use of a known highly effective method of birth control, defined as those which results in a low failure rate: i.e. less 1% per year, (contraceptive pills, intrauterine contraceptive device, implants, vasectomized partner or sexual abstinence), for at least three consecutive months prior to the study, during the study and one month after the end of the study.
  • For male subjects with partners of child bearing potential: use of appropriate contraceptive methods (vasectomy, condoms or sexual abstinence), for at least the study period and one month after the end of the study.

Exclusion Criteria:

  • Administration of any investigational drug in the period within three months prior to informed consent.
  • Use of any prescription medication during the period 0 to 30 days or over-the-counter medication during the 0 to 5 days before entry to the study.
  • Donation or loss of greater than 400 ml of blood in the period 0 to 12 weeks before entry to the study.
  • Serious adverse reaction or hypersensitivity to any drug.
  • Inability to communicate or co-operate with the investigator because of a language problem, poor mental development or impaired cerebral function.
  • History of drug dependence (except tobacco) or psychiatric illness within the past 2 years.
  • Consumption of alcohol within 24 hours prior to dose administration.
  • Presence of pain incurred by unknown causes.
  • Pregnancy or nursing.
  • Positive urine drug screen for drugs with a high potential for abuse and low persistence in the urine.
  • Inability to refrain from smoking during study days.
  • Any other condition which, in the opinion of the investigators, is likely to interfere with the successful collection of the measures required for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01334697

Hosp. Universitario Puerta de Hierro de Majadahonda
Madrid, Spain
Clínica Universidad de Navarra
Pamplona, Spain
Sponsors and Collaborators
Digna Biotech S.L.
Principal Investigator: Belén Sádaba, MD Clínica Universidad de Pamplona

Additional Information:
Responsible Party: Digna Biotech S.L. Identifier: NCT01334697     History of Changes
Other Study ID Numbers: CT1-HEPT-01, 2010-022929-15
First Posted: April 13, 2011    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013

Keywords provided by Digna Biotech S.L.: