NCT04950504

Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-201 in Subjects Ages 16-35 With Peanut Allergy

A Two-Part 1b/2a Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-201 in Subjects Ages 16-35 With Peanut Allergy

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: COUR Pharmaceutical Development Company, Inc. · Industry
• Sex: All
• Age: 16 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study is a two-part Phase 1b/2a First-in-Human (FIH) randomized, double-blind, placebo-controlled clinical trial to assess the safety, tolerability, pharmacodynamics, and efficacy of multiple ascending doses of CNP-201 in Part A, with the goal of identifying a safe and tolerable dose level to be evaluated further in a larger number of subjects in Part B.

Detailed description

Subjects who meet all inclusion and no exclusion criteria after initial screening assessments will undergo a Skin Prick Test (SPT) followed by a baseline Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) consisting of peanut and placebo (oat) challenges, administered on two separate days to confirm an allergy to peanut. Subjects who continue to meet all inclusion and no exclusion criteria after completing both days of the DBPCFC will be enrolled into the study. To mitigate the risk of anaphylaxis ahead of administering CNP-201, all Subjects who continue to meet all inclusion and no exclusion criteria following the DBPCFC will receive subcutaneous injections of omalizumab (XOLAIR). The dose of omalizumab (XOLAIR) will follow the product label specified in the protocol and will be determined by the subject's serum IgE at Screening and weight measured at the XOLAIR Dose 1 visit. Subjects will be dosed either every 2 weeks or every 4 weeks according to the product label. Subjects who continue to meet all inclusion and no exclusion criteria will be randomized on Day 1 in a 2:1 ratio (Part A) or 1:1 ratio (Part B) to receive either CNP-201 or Placebo (0.9% Sodium Chloride USP) by intravenous (IV) infusion. Subjects will be administered CNP-201 or Placebo on Day 1 and on Day 8. Subjects will remain in the clinic on Day 1 and Day 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 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, pharmacodynamics, and immunogenicity during the Post-Dosing period.

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	CNP-201 Placebo

Timeline

• Start date: 2021-06-02
• Primary completion: 2022-06-24
• Completion: 2022-07-29
• First posted: 2021-07-06
• Last updated: 2023-09-18

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study