Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05250856
Status:
TERMINATED
Last Update Posted:
2023-12-20
First Post:
2022-02-11
Brief Title:
CNP-201 in Subjects With Peanut Allergy
Sponsor:
COUR Pharmaceutical Development Company Inc
Organization:
COUR Pharmaceutical Development Company Inc
Study Overview
Official Title:
A Phase 1b2a Study to Evaluate the Safety Tolerability and Pharmacodynamics of CNP-201 in Subjects Ages 16-55 With Peanut Allergy
Status:
TERMINATED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lagging Enrollment and Administrative Reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a Phase 1b2a clinical trial to assess the safety tolerability and pharmacodynamics of multiple ascending doses Escalation Phase of CNP-201 with the goal of identifying a safe and tolerable dose level to be evaluated further in a larger number of subjects Expansion Phase
Detailed Description:
The Escalation Phase will consist of multiple cohorts 4 subjects per cohort to identify a safe and tolerable doses The Expansion Phase will consist of up to 40 additional subjects who will receive either a Placebo or CNP-201 at a safe and tolerable dose as determined from the Escalation Phase One or more dose levels may be explored in the Expansion Phase
Subjects who meet all inclusion and no exclusion criteria at screening will be enrolled into the study
In the Escalation Phase each cohort of four 4 subjects will receive CNP-201 by intravenous IV infusion on Days 1 and 8 Subjects in the Expansion Phase will be randomized in a 11 ratio to receive either a safe and tolerable dose level of CNP-201 identified in the Escalation Phase or Placebo 09 Sodium Chloride for injection
Subjects will remain in the clinic on Days 1 and 8 from the time of admission prior to administration of CNP-201 or Placebo through the final procedure conducted 4-hours post-dose that same day unless an infusion reaction anaphylaxis or other adverse event requires an extended duration of monitoring Subjects will be discharged if safety parameters are acceptable to the investigator Seven 7 days after the second administration of CNP-201 or Placebo subjects must return to the clinic for collection of safety labs PD measurements and assessment of AEs and medication changes
Subjects will continue to be followed for safety and tolerability during a 52-day Post-Dosing period
On Day 60 subjects will return to the clinic for collection of immune safety labs PD measurements and to undergo Day 1 a Double-Blind Placebo-Controlled Food Challenge DBPCFC consisting of peanut and placebo oat challenges On Day 61 subjects will return to the clinic to undergo Day 2 of the DBPCFC and final assessment of AEs and medication changes
The total duration of the study for an individual subject is approximately 67 days 7 days for Screening 8 days for CNP-201 or Placebo dosing and 52 days post-dosing evaluation
Subjects who meet all inclusion and no exclusion criteria at screening will be enrolled into the study
In the Escalation Phase each cohort of four 4 subjects will receive CNP-201 by intravenous IV infusion on Days 1 and 8 Subjects in the Expansion Phase will be randomized in a 11 ratio to receive either a safe and tolerable dose level of CNP-201 identified in the Escalation Phase or Placebo 09 Sodium Chloride for injection
Subjects will remain in the clinic on Days 1 and 8 from the time of admission prior to administration of CNP-201 or Placebo through the final procedure conducted 4-hours post-dose that same day unless an infusion reaction anaphylaxis or other adverse event requires an extended duration of monitoring Subjects will be discharged if safety parameters are acceptable to the investigator Seven 7 days after the second administration of CNP-201 or Placebo subjects must return to the clinic for collection of safety labs PD measurements and assessment of AEs and medication changes
Subjects will continue to be followed for safety and tolerability during a 52-day Post-Dosing period
On Day 60 subjects will return to the clinic for collection of immune safety labs PD measurements and to undergo Day 1 a Double-Blind Placebo-Controlled Food Challenge DBPCFC consisting of peanut and placebo oat challenges On Day 61 subjects will return to the clinic to undergo Day 2 of the DBPCFC and final assessment of AEs and medication changes
The total duration of the study for an individual subject is approximately 67 days 7 days for Screening 8 days for CNP-201 or Placebo dosing and 52 days post-dosing evaluation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None