NCT05250856

CNP-201 in Subjects With Peanut Allergy

A Phase 1b/2a Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of CNP-201 in Subjects Ages 16-55 With Peanut Allergy

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: COUR Pharmaceutical Development Company, Inc. · Industry
• Sex: All
• Age: 16 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase 1b/2a 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 dose(s). 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 1:1 ratio to receive either a safe and tolerable dose level of CNP-201 identified in the Escalation Phase or Placebo (0.9% 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.

Conditions

• Peanut Allergy

Interventions

Type	Name	Description
DRUG	CNP-201	CNP-201 is comprised of purified peanut extract (PPE) drug substance dispersed within a negatively charged polymer matrix of poly (lactic-co-glycolic acid) (PLGA) particles at a target concentration of \~5 μg of PPE per mg of PLGA.
DRUG	Placebo	Placebo, (0.9% Sodium Chloride for IV infusion)

Timeline

• Start date: 2022-03-14
• Primary completion: 2023-12-12
• Completion: 2023-12-12
• First posted: 2022-02-22
• Last updated: 2023-12-20

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study