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NCT05628740 · ClinicalTrials.gov registry record · Phase 1
Placebo-controlled, Single and Multiple Dose Study in Healthy Volunteers and Refractory Chronic Cough Patients to Assess the Safety, Tolerability, and Pharmacokinetics of Two Formulations of NTX-1175
A Phase 1 study of Refractory Chronic Cough, sponsored by Nocion Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 3
- Study locations
NCT05628740: Completed Phase 1 study of Refractory Chronic Cough, sponsored by Nocion Therapeutics.
NCT05628740 is a Phase 1 study of Refractory Chronic Cough that has completed, run by Nocion Therapeutics. The registered enrollment target is 24 participants, below the 386-participant average among 5 other Refractory Chronic Cough trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05628740, a Phase 1 study of Refractory Chronic Cough, has completed, sponsored by Nocion Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 3
- Study locations
Study Summary
Part 1 will evaluate the safety, tolerability and PK of single doses of three dose levels of NTX-1175 drug substance administered by dry powder inhaler (NOC-110) compared to a single dose reference nebulizer (NOC-100) treatment in healthy participants. Part 2 will evaluate the safety, tolerability and PK of multiple doses of NTX-1175 drug substance administered by dry powder inhaler (NOC-110) to participants with refractory chronic cough. Part 2 will also evaluate the treatment effect of multiple doses of one dose level of NTX-1175 drug substance administered by dry powder inhaler (NOC-110).
Primary Outcome
To evaluate the safety and tolerability of single doses of three dose levels of NTX-1175 drug substance administered by DPI (Drug Product NOC-110) compared to a single dose reference nebulizer treatment (Drug Product NOC-100) in healthy participants, number and severity of TEAEs following single doses of NOC-110 or placebo administered with a DPI compared to a reference period administration of NOC 100 via a nebulizer in healthy adult participants will be reported.
Conditions Studied
Interventions
- DRUG 3 mg NOC-100 (via nebulizer)
- DRUG 1 mg NOC-110 (via DPI) [1x 1 mg capsule]
- DRUG 3 mg NOC-110 (via DPI)
- DRUG Placebo (via DPI)
- DRUG 6 mg NOC-110 (via DPI)
Study Locations (3)
Florida
- Clinical Site Partners - Leesburg
- Clinical Site Partners - Winter Park
Arizona
- Celerion - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-02-07 |
| Est. Completion | 2022-10-25 |
| Phase | Phase 1 |
What the finished NCT05628740 record still lists
NCT05628740 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 386-participant average among 5 other Refractory Chronic Cough trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Refractory Chronic Cough appearing as the primary indexed condition, and to 5 interventions - of which 3 mg NOC-100 (via nebulizer) is the first listed.
NCT05628740 reports a single indexed study location in Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT05628740 about?
NCT05628740 is a clinical study titled "Placebo-controlled, Single and Multiple Dose Study in Healthy Volunteers and Refractory Chronic Cough Patients to Assess the Safety, Tolerability, and Pharmacokinetics of Two Formulations of NTX-1175". Part 1 will evaluate the safety, tolerability and PK of single doses of three dose levels of NTX-1175 drug substance administered by dry powder inhaler (NOC-110) compared to a single dose reference nebulizer (NOC-100) treatment in healthy participants. Part 2 will evaluate the safety, tolerability ...
What is the current status of trial NCT05628740?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2022-02-07. Estimated completion is 2022-10-25.
What conditions does trial NCT05628740 study?
This clinical trial studies the following conditions: Refractory Chronic Cough.
What interventions are being tested in trial NCT05628740?
The interventions under investigation include: 3 mg NOC-100 (via nebulizer) (DRUG), 1 mg NOC-110 (via DPI) [1x 1 mg capsule] (DRUG), 3 mg NOC-110 (via DPI) (DRUG), Placebo (via DPI) (DRUG), 6 mg NOC-110 (via DPI) (DRUG).
Who is sponsoring clinical trial NCT05628740?
This trial is sponsored by Nocion Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05628740 being conducted?
This trial has 3 study locations across Arizona, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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