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 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 12:09 AM
NCT ID:
NCT03748758
Eligibility Criteria:
Inclusion Criteria includes but is not limited to:
1. Body mass index of 18 to 30 kg/m2 (inclusive) and a minimum body weight of 50 kg at Screening.
2. Able and willing to follow study instructions (including compliance with daily study treatment administration) and likely to complete all required study visits as assessed by the Investigator's judgement.
3. Female subjects must agree to use an acceptable method of contraception (for pregnancy considerations and contraceptive requirements).
4. Female subjects who are of childbearing potential must have a negative urine pregnancy test result at Screening and Day -1 prior to randomization.
5. Male subjects must agree to use contraception
6. Subjects must agree to refrain from immersing their head fully under water (eg, swimming, diving) from the time of signed informed consent until after the study exit visit.
7. Physiologic tympanogram classified as Type A (normal) by the Investigator or designee.
Exclusion Criteria includes but is not limited to:
1. History or presence of significant medical condition or a clinically significant abnormal finding, as determined by the Investigator.
2. Presence of a clinically significant abnormal olfactory test finding at Screening defined as a total UPSIT score \<35 (for females) and \<34 (for males).
3. Clinically significant ear disorder/disease currently or within 6 weeks prior to Screening.
4. History of tympanostomy tubes in one or both ears within 1 year prior to Screening.
5. Upper respiratory tract infection or pharyngitis currently or within 6 weeks prior to Screening.
6. Allergy or sinus conditions (eg, sinusitis, non-specific nasal inflammation) currently or within 6 weeks prior to Screening.
7. Clinically relevant blockage of one or both nasal passages, in the Investigator's opinion.
8. Gastroesophageal reflux disease currently or within 6 weeks prior to Screening.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03748758
Study Brief:
Protocol Section:
NCT03748758