NCT03828149 is a Phase 1 clinical trial of Drug:OP0201 in Healthy Adults, sponsored by Novus Therapeutics, Inc.

Who is sponsoring NCT03828149?

NCT03828149 is sponsored by Novus Therapeutics, Inc.

What drugs are being tested in NCT03828149?

Interventions in NCT03828149: Drug:OP0201, Drug: Placebo.

What condition does NCT03828149 study?

NCT03828149 studies Healthy Adults.

Is NCT03828149 still recruiting?

NCT03828149 is currently completed. Last updated 30 December 2019.

Are results published for NCT03828149?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-12-30 · How we verify

NCT03828149

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults

Completed Phase 1 Results posted Last updated 30 December 2019

What this trial tests

Phase 1 trial testing Drug:OP0201 in Healthy Adults in 17 participants. Completed in 7 March 2019.

Timeline

8 February 2019

Primary endpoint
7 March 2019

7 March 2019

Quick facts

Lead sponsor	Novus Therapeutics, Inc
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	other
Enrollment	17
Start date	8 February 2019
Primary completion	7 March 2019
Estimated completion	7 March 2019
Sites	1 location across Germany

Drugs / interventions tested

Drug:OP0201
Drug: Placebo — full drug profile →

Conditions studied

Healthy Adults — all drugs for Healthy Adults →

Sponsor

Novus Therapeutics, Inc — full company profile →

Who can join

Adults 18 to 50, any sex, with Healthy Adults. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Safety (Evaluation of Adverse Events) Primary · Days 1-9

All randomized participants who received at least one spray of study treatment in either nare were included in the safety analysis.

Group	Value	95% CI
Drug: OP0201	17
Drug: Placebo	17

Adverse events — posted to ClinicalTrials.gov

Time frame: 9 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

OP0201

Serious: 0/17 (0%)

Deaths: 0/17

Placebo

Serious: 0/17 (0%)

Deaths: 0/17

Other adverse events (11 terms — click to expand)

Reaction	System	OP0201	Placebo
Ear Pain	Ear and labyrinth disorders	—	—
Tympanic membrane hyperaemia	Ear and labyrinth disorders	—	—
Tympanic membrane disorder	Ear and labyrinth disorders	—	—
Headache	Nervous system disorders	—	—
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—
Ear discomfort	Ear and labyrinth disorders	—	—
Dizziness	Nervous system disorders	—	—
Nasal injury	Respiratory, thoracic and mediastinal disorders	—	—
Fatigue	General disorders	—	—
Peripheral swelling	General disorders	—	—

Data from ClinicalTrials.gov NCT03828149 adverse events section.

Sponsor's own description

Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Novus Therapeutics, Inc trials

Trials by the same sponsor.

NCT03818815 — A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infa · Phase 2 · completed
NCT03766373 — Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media and Reduction of Ear Pain in Adults Wit · Phase 1 · completed
NCT03748758 — Evaluation of Safety of Repeated Doses of OP0201 Metered Dose Inhaler Compared to Placebo in Healthy Adult Volunteers · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03828149 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novus Therapeutics, Inc
Last refreshed: 30 December 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03828149.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing