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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01334697
• Other study ID #: CT1-HEPT-01, 2010-022929-15
• Status: Active, not recruiting
• Phase: Phase 1
• First received: April 5, 2011
• Last updated: July 29, 2013
• Start date: November 2012
• Est. completion date: August 2013

Study information

• Verified date: July 2013
• Source: Digna Biotech S.L.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• recombinant human cardiotrophin-1
Single dose intravenous administration

Other:
• Placebo
Single dose intravenous administration

Locations

Country	Name	City	State
Spain	Hosp. Universitario Puerta de Hierro de Majadahonda	Madrid
Spain	Clínica Universidad de Navarra	Pamplona

Sponsors (1)

Lead Sponsor	Collaborator
Digna Biotech S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No

External Links

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