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:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT01775358
Eligibility Criteria:
Inclusion Criteria:
1. Healthy male or female subjects aged 20 to 50 years, inclusive, at the time of informed consent.
2. Subjects must be in good health as determined by the Investigator based on detailed medical history, physical examination, vital signs, clinical laboratory tests, ECGs and other screening evaluations.
3. Ability to provide written informed consent and complying with all study requirements and restrictions.
4. Is a non-smoker and non-tobacco user for a minimum of 6 months prior to screening
Exclusion Criteria:
1. History or current evidence of any clinically significant cardiac, endocrinologic, hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator
2. Previous treatment with any GH Releasing Hormone (GHRH) analog.
3. Participation in another clinical trial or treatment with an investigational agent within 30 days or 5 half-lives, whichever is longer, prior to enrollment.
4. History of cancer within the past five years (excluding non-melanoma skin cancer).
5. History of alcohol or drug abuse or dependence within 12 months of screening as determined by the Investigator.
6. Subjects with a body weight \> 120 kg.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
50 Years
Study:
NCT01775358
Study Brief:
Protocol Section:
NCT01775358