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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
9
Medical Research of Arizona
Scottsdale, Arizona, United States
Stanford University School of Medicine / Sean N. Parker Center for Allergy and Asthma Research
Mountain View, California, United States
Peninsula Research Institute
Rolling Hills Estates, California, United States
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Frequency tables will be presented by treatment group for all AEs and SAEs by System Organ Class (SOC) and Preferred Term (PT). Frequency tables will also be produced by treatment group for AEs leading to discontinuation from TP and study, by severity, and by causality. No formal statistical testing will be done.
Time frame: through Study Completion, an average of 90 Days
Serum Cytokines (TNF-α, IL-2, IL-6, IL-8, IL-1β, MCP-1, MIP-1β, MIP-1α, IFN-γ, and IL-12p70)
Serum Cytokines (TNF-α, IL-2, IL-6, IL-8, IL-1β, MCP-1, MIP-1β, MIP-1α, IFN-γ, and IL-12p70)
Time frame: through Study Completion, an average of 90 Days
Change in the proportion of peanut specific Th2a+ T cells (peanut specific Th2a+ cells / total peanut specific T cells)
Change in the proportion of peanut specific Th2a+ T cells (peanut specific Th2a+ cells / total peanut specific T cells) following ex vivo stimulation of PBMCs between placebo and CNP-201
Time frame: Baseline (Day 1 pre-dose) and at Day 15
Change in the proportion of activated peanut specific T cells (activated peanut specific T cells / total peanut specific T cells)
Change in the proportion of activated peanut specific T cells (activated peanut specific T cells / total peanut specific T cells) following ex vivo stimulation of PBMCs between placebo and CNP-201
Time frame: Baseline (Day 1 pre-dose) and at Day 15
Change in the ratio of IL-5 to IFN-γ
Change in the ratio of IL-5 to IFN-γ following ex vivo stimulation of PBMCs between placebo and CNP-201
Time frame: Baseline (Day 1 pre-dose) and at Day 15
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Allergy & Asthma Medical Group and Research Center
San Diego, California, United States
Allergy & Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States
Pharmaceutical Research & Consulting, Inc
Dallas, Texas, United States
Western Sky Medical Research
El Paso, Texas, United States
Seattle Allergy & Asthma
Seattle, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States