Study of CYR-064 Versus Placebo in Patients.

Completed · Phase 2 · Has a placebo group

Conditions studied: Hyposmia

In brief

Randomized, double-blinded, placebo-controlled trial to determine the safety and efficacy of CYR-064.

Key facts

Study ID

NCT06019000

Run by

Cyrano Therapeutics, Inc.

People needed

151

Starts

2023-09-26

Expected to finish

2025-11-21

Last updated by the study team

2026-02-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to provide written informed consent.
• Male or female 18-70 years of age.
• Endoscopy of the nasal cavity showing no structural or pathologic issues leading to hyposmia (nasal polyps, sinusitis, infection, etc.) that in the opinion of the Investigator, believes would hinder the delivery of study drug to the olfactory receptors.
• CT scan of the nasal cavity after the onset of hyposmia (within prior 2 years) prior to Baseline showing no structural or pathologic issue leading to hyposmia that in the opinion of the Investigator, believes would hinder the delivery of study drug to the olfactory receptors.
• Willing and able to self-administer the study drug, follow the study drug administration instructions, comply with study procedures, and participate in the scheduled study visits specified in this protocol.

You may not qualify if…

• History of traumatic brain injury, Parkinson's disease, early dementia, Alzheimer's disease, or any other condition in which hyposmia is not expected to improve in the opinion of the Investigator, such as history of congenital or idiopathic hyposmia or a surgical procedure that led to hyposmia.
• History of surgery that led to hyposmia.
• Concomitant Medical Conditions
• Current symptoms or signs of an acute respiratory viral illness at Screening or Baseline.
• Chronic viral infection or immunodeficiency condition (e.g., medical history of human immunodeficiency virus) based on medical records.
• Any active malignancy.
• Any concomitant medical condition that in the opinion of the Investigator, compromises patient safety or compliance with the study protocol or collected data.
• History of moderate to severe Substance Use Disorder within the past 3 years as assessed by the Investigator.
• History of persistent chronic sinusitis without polyps or chronic sinusitis with polyps.
• Use or planned use of tobacco or nicotine-containing products, including smoking, smokeless tobacco, e-cigarettes, or nicotine replacement products within 3 months prior to Screening through EOS.
• Unwilling or unable to discontinue current or planned use of over the counter or prescription medication administered intranasally, with the exception of nasal saline.
• Use or planned use of another investigational drug within 4 weeks prior to Screening through Follow-Up.
• Receiving any concomitant medication/therapy that would, in the opinion of the Investigator, compromise patient safety or compliance with the study protocol or collected data.
• General Exclusions Any female who is pregnant, planning to become pregnant during the study, or who is lactating.
• Vulnerable patients. Any condition or abnormality (including clinical laboratory, physical examination, or vital sign abnormalities), current or past, that, in the opinion of the Investigator, would compromise the efficacy evaluation, safety of the patient, or would interfere with or complicate study procedures or assessments.

Where it is running

• Colorado ENT & Allergy — Colorado Springs, Colorado, United States
• ENTAAFL — Boca Raton, Florida, United States
• ENTAAFL — Plantation, Florida, United States
• ENTAAFL — Port Saint Lucie, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• KU Medical Center-University of Kansas — Kansas City, Kansas, United States
• Advanced ENT and Allergy — Louisville, Kentucky, United States
• Tandem Clinical Research — Marrero, Louisiana, United States
• Centers for Advanced ENT — Baltimore, Maryland, United States
• Specialty Physician Associates — Bethlehem, Pennsylvania, United States
• Medical University of South Carolina-MUSC — Charleston, South Carolina, United States
• Charleston ENT and Allergy — North Charleston, South Carolina, United States
• Houston Methodist — Houston, Texas, United States
• Ear Nose Throat & Allergy Associates — Puyallup, Washington, United States

Full record on ClinicalTrials.gov

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