Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers

Inclusion criteria

includes but is not limited to:

• Body mass index of 18 to 30 kg/m2 (inclusive) and a minimum body weight of 50 kg at Screening.
• 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.
• Female subjects must agree to use an acceptable method of contraception (for pregnancy considerations and contraceptive requirements).
• Female subjects who are of childbearing potential must have a negative urine pregnancy test result at Screening and Day -1 prior to randomization.
• Male subjects must agree to use contraception
• 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.
• Physiologic tympanogram classified as Type A (normal) by the Investigator or designee.

Exclusion criteria

includes but is not limited to:

• History or presence of significant medical condition or a clinically significant abnormal finding, as determined by the Investigator.
• Presence of a clinically significant abnormal olfactory test finding at Screening defined as a total UPSIT score <35 (for females) and <34 (for males).
• Clinically significant ear disorder/disease currently or within 6 weeks prior to Screening.
• History of tympanostomy tubes in one or both ears within 1 year prior to Screening.
• Upper respiratory tract infection or pharyngitis currently or within 6 weeks prior to Screening.
• Allergy or sinus conditions (eg, sinusitis, non-specific nasal inflammation) currently or within 6 weeks prior to Screening.
• Clinically relevant blockage of one or both nasal passages, in the Investigator's opinion.
• Gastroesophageal reflux disease currently or within 6 weeks prior to Screening.