NCT05250856

CNP-201 in Subjects With Peanut Allergy

Terminated Phase 1 Last updated 20 December 2023

What this trial tests

Phase 1 trial testing CNP-201 in Peanut Allergy in 15 participants. Terminated before completion.

Timeline

14 March 2022

Primary endpoint
12 December 2023

12 December 2023

Quick facts

Lead sponsor	COUR Pharmaceutical Development Company, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	15
Start date	14 March 2022
Primary completion	12 December 2023
Estimated completion	12 December 2023
Sites	17 locations across United States

Drugs / interventions tested

• CNP-201 — full drug profile →
• Placebo

Conditions studied

• Peanut Allergy — all drugs for Peanut Allergy →

Sponsor

COUR Pharmaceutical Development Company, Inc. — full company profile →

Who can join

Adults 16 to 55, any sex, with Peanut Allergy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. PLGA-Based Nanomedicine: History of Advancement and Development in Clinical Applications of Multiple Diseases.
   Alsaab HO, Alharbi FD, Alhibs AS, Alanazi NB, et al · · 2022 · cited 141× · PMID 36559223 · DOI 10.3390/pharmaceutics14122728
2. Feast for thought: A comprehensive review of food allergy 2021-2023.
   Bartha I, Almulhem N, Santos AF. · · 2024 · cited 74× · PMID 38101757 · DOI 10.1016/j.jaci.2023.11.918
3. Treatment of food allergy: Oral immunotherapy, biologics, and beyond.
   Sindher SB, Hillier C, Anderson B, Long A, et al · · 2023 · cited 22× · PMID 37100276 · DOI 10.1016/j.anai.2023.04.023
4. A novel peanut allergy immunotherapy: Plant-based enveloped Ara h 2 Bioparticles activate dendritic cells and polarize T cell responses to Th1.
   Castenmiller C, Nagy NA, Kroon PZ, Auger L, et al · · 2023 · cited 4× · PMID 38020282 · DOI 10.1016/j.waojou.2023.100839
5. Update on clinical research for food allergy treatment.
   Fowler J, Lieberman J. · · 2023 · cited 4× · PMID 37520143 · DOI 10.3389/falgy.2023.1154541
6. Next-Generation Allergen-Specific Immunotherapy for Food Allergy.
   Lee JZX, Sit JKC, Leung NYH, Chu KH, et al · · 2025 · cited 3× · PMID 41123726 · DOI 10.1007/s12016-025-09104-8
7. Regulatory T Cells and Nanomaterials: Dual Perspectives in Therapeutics and Immunomodulation.
   Chen Y, Huang H, Wang X, Yu X, et al · · 2026 · PMID 41537174 · DOI 10.1002/smsc.202500481
8. Editorial: Food allergy: advances in basic and translational animal models.
   Dolence JJ, Krempski JW, O'Konek JJ. · · 2023 · PMID 37885609 · DOI 10.3389/falgy.2023.1299113