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NCT06656806 · ClinicalTrials.gov registry record · Early Phase 1
Efficacy and Safety of Inhaled NC-107 As Compared to Placebo After 4 Weeks of Treatment in Patients with Anxiety
A Early Phase 1 study, sponsored by Trinity Hypertension & Metabolic Research Institute.
- Not yet
- Registry status
- Early Phase 1
- Development phase
- 40
- Enrollment target
NCT06656806 is a Early Phase 1 study that has not yet begun recruiting, run by Trinity Hypertension & Metabolic Research Institute. The registered enrollment target is 40 participants.
The verdict
NCT06656806, a Early Phase 1 study, has not yet begun recruiting, sponsored by Trinity Hypertension & Metabolic Research Institute.
- NOT YET RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 40 participants
- Enrollment target
Study 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.
Interventions
- DRUG Measure concentrations of CBD in spot urine collections from subjects treated with inhaled CBD
- DRUG Determine the presence and concentration of CBD in subject's plasma with inhaled CBD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-12-01 |
| Est. Completion | 2025-05-01 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06656806
The ClinicalTrials.gov registry entry for NCT06656806 describes a study currently listed as not yet recruiting, categorized as Early Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Trinity Hypertension & Metabolic Research Institute, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Measure concentrations of CBD in spot urine collections from subjects treated with inhaled CBD is the first listed.
NCT06656806 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06656806 about?
NCT06656806 is a clinical study titled "Efficacy and Safety of Inhaled NC-107 As Compared to Placebo After 4 Weeks of Treatment in Patients with Anxiety". 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 is the current status of trial NCT06656806?
This trial is currently not yet recruiting. It is a Early Phase 1 study. The enrollment target is 40 participants. The study started on 2024-12-01. Estimated completion is 2025-05-01.
What interventions are being tested in trial NCT06656806?
The interventions under investigation include: Measure concentrations of CBD in spot urine collections from subjects treated with inhaled CBD (DRUG), Determine the presence and concentration of CBD in subject's plasma with inhaled CBD (DRUG).
Who is sponsoring clinical trial NCT06656806?
This trial is sponsored by Trinity Hypertension & Metabolic Research Institute, which has 3 total clinical trials registered on ClinicalTrials.gov.
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