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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT02725957
Eligibility Criteria:
Inclusion Criteria:
1. Healthy men and women between 18 and 55 years (inclusive) of age
2. Body Mass Index (BMI) 19 to 29.9 kg/m2 (inclusive) and weighing at least 55 kg.
3. Subjects in general good health in the opinion of the investigator
4. Blood pressure and heart rate within normal limits
5. Female subjects must have a negative serum pregnancy test during the Screening period (Day -28 to -1) and be willing and able to use a medically acceptable method of birth control or be postmenopausal.
Exclusion Criteria:
1. Diabetes mellitus type 1 or 2 or HbA1c \> 5.6 % at Screening
2. History of significant medical disorder
3. Any clinically significant abnormality in safety laboratory tests during the Screening period (Day -28 to -1)
4. Known contraindication, hypersensitivity and/or allergy to trehalose
5. Any acute illness (e.g. acute infection) within 72 hours
6. Participation in another clinical trial with drugs received within 3 months prior to dosing
7. Positive serum pregnancy test determined during the Screening period or currently lactating women
8. ECG with clinically significant finding recorded during the Screening period
9. Positive HIV, Hepatitis B or Hepatitis C serology at Screening
10. Known history of alcohol or drug abuse in the past 5 years
11. Positive urinary drug screen determined during the Screening period
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT02725957
Study Brief:
Protocol Section:
NCT02725957