Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers
NCT ID: NCT03748758
Last Updated: 2020-02-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2018-11-27
2019-03-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Drug: OP0201 (30 mg)
Cohort A- 30 mg per day X 14 days
Drug: OP0201
Drug OP0201
Drug: Placebo
Cohort A- 0 mg per day X 14 days Cohort B- 0 mg per day X 14 days
Drug: Placebo
Placebo
Drug: OP0201 (60 mg)
Cohort B-60 mg per day X 14 days
Drug: OP0201
Drug OP0201
Interventions
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Drug: OP0201
Drug OP0201
Drug: Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
50 Years
ALL
Yes
Sponsors
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Novus Therapeutics, Inc
INDUSTRY
Responsible Party
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Locations
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Vince and Associates
Overland Park, Kansas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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OP0201-C-002
Identifier Type: -
Identifier Source: org_study_id
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