Clinical trial NCT03748758: Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers
Official title: Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult Volunteers
Lead sponsor: Novus Therapeutics, Inc
Sponsor class: INDUSTRY
First posted: 2018-11-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the safety and tolerability of two dose levels of OP0201 and placebo, when administered intranasally in healthy adults subjects.


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.

Primary outcomes:
measure: Number of Participants With of Adverse Events
timeFrame: 21 Days
Secondary outcomes:
measure: Evaluation of Systemic Exposure of DPPC: Observed DPPC Serum Concentration (µg/mL) by Nominal Timepoint
timeFrame: Day 1 and Day 14
measure: Evaluation of Systemic Exposure of CP: Observed CP Serum Concentrations (µM) by Nominal Timepoint
timeFrame: Day 1 and Day 14
measure: Evaluation of Systemic Exposure of DPPC: Baseline-corrected DPPC Serum Concentration (µg/mL) by Nominal Timepoint
timeFrame: Day 1 and Day 14
measure: Evaluation of Systemic Exposure of CP: Baseline-corrected CP Serum Concentrations (µM) by Nominal Timepoint
timeFrame: Day 1 and Day 14
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Vince and Associates
state: Kansas
Study officials:
References: