A Randomized, Single-Blind, Fixed-Order Crossover Study to Assess the Effects of CSX-1004 Injection on Fentanyl-Induced Respiratory Depression in Healthy Adult Subjects and Subjects with Opioid Use Disorder

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524133-33-00

Enrollment

Registered

2026-03-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid use disorder

Brief summary

Peak change in MV (absolute and % [L/min]), calculated based on a 1-minute average of the ventilation data of each individual participant.

Detailed description

Peak change in respiratory rate [breaths/min], oxygen saturation (SpO2), tidal volume [L], Incidence of apnea (≥20 sec loss of respiratory activity), Incidence of oxygen desaturation (<92%), Pupillometry (maximum pupil diameter), Alertness/Drowsiness visual analog scale (VAS) (minimum effect [Emin]), Any Drug Effects VAS (maximum effect [Emax]), Drug Liking VAS (Emax), High VAS (Emax)

Interventions

DRUGCSX-1004

DRUGNatriumchloride 0

DRUG9%

DRUGoplossing voor infusie

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Peak change in MV (absolute and % [L/min]), calculated based on a 1-minute average of the ventilation data of each individual participant.	—

Secondary

Measure	Time frame
Peak change in respiratory rate [breaths/min], oxygen saturation (SpO2), tidal volume [L], Incidence of apnea (≥20 sec loss of respiratory activity), Incidence of oxygen desaturation (<92%), Pupillometry (maximum pupil diameter), Alertness/Drowsiness visual analog scale (VAS) (minimum effect [Emin]), Any Drug Effects VAS (maximum effect [Emax]), Drug Liking VAS (Emax), High VAS (Emax)	—

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 21, 2026