Clinical trial NCT01334697: Clinical Trial to Assess the Safety, Tolerability and Pharmacokinetics of Cardiotrophin-1 in Healthy Volunteers
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Keywords: Cardiotrophin-1
CT-1
Lead sponsor: Digna Biotech S.L.
Sponsor class: INDUSTRY
First posted: 2011-04-13
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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


Eligibility 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.

Primary outcomes:
measure: Number of participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: single dose administration (baseline) and 1 post-treatment follow up week
Secondary outcomes:
measure: Pharmacokinetic and Pharmacodynamic parameters
timeFrame: single adminsitration (baseline) and 1 week of follow up
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hosp. Universitario Puerta de Hierro de Majadahonda
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
Study officials:
affiliation: Clínica Universidad de Pamplona
name: Belén Sádaba, MD
role: PRINCIPAL_INVESTIGATOR
References: