CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 17 enrolled
Drug / intervention
Drug:OP0201 +1 morecombination
Likely dose
Not stated in record
Key inclusion· 5
  • ✓BMI 18–30 kg/m² with minimum body weight ≥50 kg
  • ✓No significant medical condition or clinically significant abnormal finding
  • ✓Normal ear function: physiologic tympanogram type A (normal) or type C
  • ✓Negative urine pregnancy test (females of childbearing potential)
Key exclusion· 11
  • ✕Known substance abuse (alcohol, illicit or licit drugs) within 96 weeks prior to screening
  • ✕Positive urine drug screen at screening
  • ✕Upper respiratory tract infection currently or within 6 weeks prior to screening
  • ✕Allergy or sinus conditions (sinusitis, non-specific nasal inflammation) currently or within 6 weeks prior to screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03828149
NCT03828149Phase 1Completed
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Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo

Novus Therapeutics, Inc·interventional·Posted Feb 4, 2019·Updated Dec 30, 2019

In Brief

A Phase 1 clinical trial evaluating Drug:OP0201 and Drug: Placebo for Healthy Adults. Completed, enrolled 17 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy Adults
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedFeb 4, 2019
Enrollment StartFeb 8, 2019
Primary CompletionMar 7, 2019
TodayJul 2, 2026
Enrollment to primary: 29 daysPosted 7.4 years ago

Interventions

Drug:OP0201combination

Drug: OP0201

Drug: Placebocombination

Drug: Placebo