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

Digna Biotech

Status and phase

Unknown

Phase 1

Conditions

Healthy

Treatments

Other: Placebo

Drug: recombinant human cardiotrophin-1

Study type

Interventional

Funder types

Industry

Identifiers

CT1-HEPT-01, 2010-022929-15

Details and patient eligibility

About

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

Enrollment

33 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.