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

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ClinicalTrials.gov Identifier: NCT03748758
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Novus Therapeutics, Inc

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.

Condition or disease Intervention/treatment Phase
Healthy Adult Volunteers Combination Product: Drug: OP0201 Combination Product: Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Arm Intervention/treatment
Active Comparator: Drug: OP0201
Cohort A- 30 mg per day X 14 days Cohort B-60 mg per day X 14 days
Combination Product: Drug: OP0201
Drug OP0201

Placebo Comparator: Drug: Placebo
Cohort A- 0 mg per day X 14 days Cohort B- 0 mg per day X 14 days
Combination Product: Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Safety (Evaluation of Adverse Events) [ Time Frame: 21 Days ]

Secondary Outcome Measures :
  1. Evaluation of systemic exposure of DPPC in plasma at levels higher than endogenous DPPC [ Time Frame: Day 1 and Day 14 ]
    This will be evaluated by collecting blood on Day 1 and Day 14.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748758


Contacts
Contact: Amy Tran 949-238-8090 Study002@novustherapeutics.com

Locations
United States, Kansas
Vince and Associates Recruiting
Overland Park, Kansas, United States, 66212
Contact: Martin K Kankam, M.D., PhD, MPH         
Sponsors and Collaborators
Novus Therapeutics, Inc

Additional Information:
Responsible Party: Novus Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT03748758     History of Changes
Other Study ID Numbers: OP0201-C-002
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No