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
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.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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