Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT03062956
Eligibility Criteria:
Inclusion Criteria:
* Weight between 60 and 90 kg inclusive
* Resting heart rate of \< 80 beats per minute
* Documented LVEF greater than or equal to 55% during Screening
* Normal electrocardiogram (ECG) at Screening
* Normal acoustic windows on transthoracic echocardiograms at Screening
* All safety laboratory parameters within normal limits at Screening
* History or evidence of another clinically significant disorder, in the opinion of the investigator.
Exclusion Criteria:
* Active infection
* History of coronary artery disease
* History of malignancy with the exception of in situ cervical cancer more than 5 years prior to Screening or surgically-excised non-melanomatous skin cancers more than 2 years prior to Screening
* Positive serology tests at screening
* Current use of tobacco or nicotine-containing products exceeding 10 per day.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT03062956
Study Brief:
Protocol Section:
NCT03062956