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

NCT01334697 | Unknown Phase 1 DMC

• 1 other identifier: CT1-HEPT-01, 2010-022929-15
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy

Keywords

Cardiotrophin-1; CT-1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pharmacokinetic and Pharmacodynamic parameters

  single adminsitration (baseline) and 1 week of follow up

Study Arms (2)

Cardiotrophin-1

EXPERIMENTAL

Drug: recombinant human cardiotrophin-1

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

recombinant human cardiotrophin-1 DRUG

Single dose intravenous administration

Cardiotrophin-1

Placebo OTHER

Single dose intravenous administration

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Digna Biotech S.L.: lead

Study Sites (2)

Hosp. Universitario Puerta de Hierro de Majadahonda

Madrid, Spain

Location

Clínica Universidad de Navarra

Pamplona, Spain

Location

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Study Officials

• Belén Sádaba, MD

  Clínica Universidad de Pamplona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2011
• First Posted: April 13, 2011
• Study Start: November 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: July 30, 2013

Record last verified: 2013-07

Locations

ES (2)