NCT03748758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 21, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

November 27, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
11 months until next milestone

Results Posted

Study results publicly available

February 25, 2020

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

November 13, 2018

Results QC Date

January 30, 2020

Last Update Submit

February 11, 2020

Conditions

Healthy Adult Volunteers

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With of Adverse Events

    21 Days

Secondary Outcomes (4)

  • Evaluation of Systemic Exposure of DPPC: Observed DPPC Serum Concentration (µg/mL) by Nominal Timepoint

    Day 1 and Day 14

  • Evaluation of Systemic Exposure of CP: Observed CP Serum Concentrations (µM) by Nominal Timepoint

    Day 1 and Day 14

  • Evaluation of Systemic Exposure of DPPC: Baseline-corrected DPPC Serum Concentration (µg/mL) by Nominal Timepoint

    Day 1 and Day 14

  • Evaluation of Systemic Exposure of CP: Baseline-corrected CP Serum Concentrations (µM) by Nominal Timepoint

    Day 1 and Day 14

Study Arms (3)

Drug: OP0201 (30 mg)

ACTIVE COMPARATOR

Cohort A- 30 mg per day X 14 days

Combination Product: Drug: OP0201

Drug: Placebo

PLACEBO COMPARATOR

Cohort A- 0 mg per day X 14 days Cohort B- 0 mg per day X 14 days

Combination Product: Drug: Placebo

Drug: OP0201 (60 mg)

ACTIVE COMPARATOR

Cohort B-60 mg per day X 14 days

Combination Product: Drug: OP0201

Interventions

Drug: OP0201COMBINATION_PRODUCT

Drug OP0201

Drug: OP0201 (30 mg)Drug: OP0201 (60 mg)
Drug: PlaceboCOMBINATION_PRODUCT

Placebo

Drug: Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vince and Associates

Overland Park, Kansas, 66212, United States

Location

Related Links

Results Point of Contact

Title
Clinical Director
Organization
Novus Therapeutics
study002@novustherapeutics.com
949-679-1110

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2018

First Posted

November 21, 2018

Study Start

November 27, 2018

Primary Completion

March 20, 2019

Study Completion

March 20, 2019

Last Updated

February 25, 2020

Results First Posted

February 25, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)