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

• Sponsor: Digna Biotech S.L. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01334697
• Collaborator: (none)
• Enrollment: 33
• Locations: 2
• Arms: 2
• Duration (Months): 9
• Patients Per Site: 16.5
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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 Design

• Study Type: Interventional
• Anticipated 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: Nov 1, 2012
• Anticipated Primary Completion Date: Aug 1, 2013
• Anticipated Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cardiotrophin-1	Drug: recombinant human cardiotrophin-1; Single dose intravenous administration
Placebo Comparator: Placebo	Other: Placebo; Single dose intravenous administration

Outcome Measures

Primary Outcome Measures

1. Number of participants with Adverse Events as a Measure of Safety and Tolerability [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hosp. Universitario Puerta de Hierro de Majadahonda	Madrid		Spain
2	Clínica Universidad de Navarra	Pamplona		Spain

Sponsors and Collaborators

• Digna Biotech S.L.

Investigators

• Principal Investigator: Belén Sádaba, MD, Clínica Universidad de Pamplona

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Digna Biotech S.L.
• ClinicalTrials.gov Identifier: NCT01334697
• Other Study ID Numbers: CT1-HEPT-01, 2010-022929-15
• First Posted: Apr 13, 2011
• Last Update Posted: Jul 30, 2013
• Last Verified: Jul 1, 2013

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

Study Results

No Results Posted as of Jul 30, 2013