NCT06656806

Efficacy and Safety of Inhaled NC-107 As Compared to Placebo After 4 Weeks of Treatment in Patients with Anxiety

A Double-Blind, Placebo-Controlled, Single Center Study to Evaluate the Efficacy and Safety of Inhaled NC-107 As Compared to Placebo After 4 Weeks of Treatment in Patients with Anxiety

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Trinity Hypertension & Metabolic Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if inhaled drug NC-107 works to treat Generalized anxiety disorder in adults. It will also learn about the safety of the drug NC-107. The main questions it aims to answer are: Does the inhaled drug NC-107 decrease the severity of anxiety in participants? What medical problems could participants have when taking drug NC-107? How quickly does NC-107 absorb and get into the blood stream? Researchers will compare drug NC-107 to a placebo (a look-alike substance that contains no drug) to see how effective NC-107 in treating generalized anxiety disorder. Participants will be equal to or above 18 years of age and sign an informed consent. They will answer two questionnaires about anxiety and have vitals taken, as well as blood drawn for laboratory results. If a questionnaire reveals moderate anxiety and all blood work is normal the patient will enter the study. The patient will be instructed on the use of an inhaler, that will deliver the medication via the lung. Two puffs twice daily of NC-107 or placebo will be used during the remainder of the study. Blood will be drawn for peak and trough levels of NC-107. Questionnaires will be completed at each visit.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	Measure concentrations of CBD in spot urine collections from subjects treated with inhaled CBD	Measure concentrations of CBD in spot urine collections from subjects with generalized anxiety disorder treated with inhaled CBD
DRUG	Determine the presence and concentration of CBD in subject's plasma with inhaled CBD	Determine the presence and concentration of CBD in plasma of subjects with generalized anxiety disorder treated with inhaled CBD

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-10-24
• Last updated: 2024-10-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study