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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Digna Biotech S.L.
ClinicalTrials.gov Identifier:
NCT01334697
First received: April 5, 2011
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Healthy
Drug: recombinant human cardiotrophin-1
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Digna Biotech S.L.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Evaluate the tolerability and safety of single dose intravenous administration


Secondary Outcome Measures:
  • Pharmacokinetic and Pharmacodynamic parameters [ Time Frame: single adminsitration (baseline) and 1 week of follow up ] [ Designated as safety issue: No ]

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

    Analyze surrogated biological markers associated with CT-1 administration



Estimated Enrollment: 33
Study Start Date: November 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cardiotrophin-1 Drug: recombinant human cardiotrophin-1
Single dose intravenous administration
Placebo Comparator: Placebo Other: Placebo
Single dose intravenous administration

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334697

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

Additional Information:
No publications provided

Responsible Party: Digna Biotech S.L.
ClinicalTrials.gov Identifier: NCT01334697     History of Changes
Other Study ID Numbers: CT1-HEPT-01, 2010-022929-15
Study First Received: April 5, 2011
Last Updated: July 29, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Digna Biotech S.L.:
Cardiotrophin-1
CT-1

ClinicalTrials.gov processed this record on September 22, 2014