This study is a Phase 1b/2a randomized, double-blind, placebo-controlled 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).
Subjects who meet all inclusion and no exclusion criteria at screening will be enrolled into
the study. Subjects will be randomized on Day 1 in a 2:1 ratio 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
Subjects will continue to be followed for safety, and tolerability during the 52-day
Post-Dosing period. Subjects will return to the clinic on Day 38 for collection of immune
safety labs and PD measurements.
On Day 60, subjects will return to the clinic for collection of immune safety labs, PD
measurements and to undergo a Double-Blind, Placebo-Controlled Food Challenge (DBPCFC)
consisting of peanut and placebo (oat) challenges. The DBPCFC will be conducted with a study
physician or staff trained to manage clinical emergencies present on site, with immediate
access to emergency medications and equipment, and within close proximity to hospital
emergency departments for rapid delivery of urgent care if needed.
An additional 120-day Post-Dosing period is optional. On Day 90 and Day 120, subjects may
choose to return to the clinic for collection of immune safety labs, and PD measurements.
Subjects may then return to the clinic for the end of study visit on Day 180 for a second
DBPCFC consisting of peanut and placebo (oat) challenges, collection of safety labs, PD
measurements, and final assessment of AEs and medication changes.
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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