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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: Clinical Trial Early Phase 1 study, sponsored by Trinity Hypertension & Metabolic Research Institute.
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, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measure the concentration of CBD in the plasma of male and female subjects with Generalized Anxiety Disorder treated with inhaled CBD.
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 |
What is known before NCT06656806 opens enrollment
NCT06656806 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06656806's enrollment target sits among peer trials
40 629th of 2000 higher than 1,312 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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