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

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

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

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Drug: recombinant human cardiotrophin-1; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Hosp. Universitario Puerta de Hierro de Majadahonda
  • Pamplona, Spain
    • Clinica Universidad de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Other: Placebo; Single dose intravenous administration
EXPERIMENTAL: Cardiotrophin-1	Drug: recombinant human cardiotrophin-1; Single dose intravenous administration

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic and Pharmacodynamic parameters	Obtain pharmacokinetic parameters before and after CT-1 single dose administration. Analyze surrogated biological markers associated with CT-1 administration	single adminsitration (baseline) and 1 week of follow up

Collaborators and Investigators

• Sponsor: Digna Biotech S.L.
• Investigators: Principal Investigator: Belén Sádaba, MD, Clínica Universidad de Pamplona

Publications and helpful links

Helpful Links

• Treatment of murine fulminant hepatitis with genetically engineered endothelial progenitor cells.
• [Obesity, inflammation and insulin resistance: role of gp 130 receptor ligands].

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ANTICIPATED): August 1, 2013
• Study Completion (ANTICIPATED): August 1, 2013

Study Registration Dates

• First Submitted: April 5, 2011
• First Submitted That Met QC Criteria: April 12, 2011
• First Posted (ESTIMATE): April 13, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 30, 2013
• Last Update Submitted That Met QC Criteria: July 29, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Cardiotrophin-1; CT-1
• Other Study ID Numbers: CT1-HEPT-01, 2010-022929-15