Status and phase
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About
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).
Full description
The Escalation Phase will consist of multiple cohorts (4 subjects per cohort) to identify a safe and tolerable dose(s). The Expansion Phase will consist of up to 40 additional subjects who will receive either a Placebo or CNP-201 at a safe and tolerable dose as determined from the Escalation Phase. One or more dose levels may be explored in the Expansion Phase.
Subjects who meet all inclusion and no exclusion criteria at screening will be enrolled into the study.
In the Escalation Phase, each cohort of four (4) subjects will receive CNP-201 by intravenous (IV) infusion on Days #1 and #8. Subjects in the Expansion Phase will be randomized in a 1:1 ratio to receive either a safe and tolerable dose level of CNP-201 identified in the Escalation Phase or Placebo (0.9% Sodium Chloride for injection).
Subjects will remain in the clinic on Days #1 and #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 (7) 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, and tolerability during a 52-day Post-Dosing period.
On Day 60, subjects will return to the clinic for collection of immune safety labs, PD measurements and to undergo Day 1 a Double-Blind, Placebo-Controlled Food Challenge (DBPCFC) consisting of peanut and placebo (oat) challenges. On Day 61, subjects will return to the clinic to undergo Day 2 of the DBPCFC and final assessment of AEs and medication changes.
The total duration of the study for an individual subject is approximately 67 days: 7 days for Screening; 8 days for CNP-201 or Placebo dosing; and 52 days post-dosing evaluation.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
Subjects with history of severe anaphylaxis to peanuts defined as neurological compromise or requiring intubation.
Subjects with peanut specific IgE ≥ 100 kU/L as measured by ImmunoCAP at Screening.
Subjects who have received administration of vaccinations in the following timeframe:
Any COVID-19 vaccine within 14 days prior to Screening. Subjects who have received the first dose of any COVID-19 vaccine may not screen for the study until 14 days following their last dose of the vaccine if applicable.
Any planned vaccination prior to Day 15.
Subjects in build-up phase of immunotherapy for aeroallergens or venom. Individuals tolerating maintenance aeroallergen or venom immunotherapy at Screening can be enrolled.
Subjects with relative contraindication or inability to use epinephrine auto-injector.
Subjects who have used the following drug(s) within 2 months prior to Screening: Th2 cytokine inhibitors, thromboxane A2 synthesis inhibitors, thromboxane A2 receptor antagonists, β-blockers, angiotensin-converting enzyme inhibitors, and/or angiotensin-receptor blockers unless, in the investigator's opinion, the underlying condition being treated by the drug is well controlled and the drug dose and frequency is not expected to interfere with the mechanism of action of CNP-201 as determined in consultation with the sponsor.
Subjects who have used biologics and/or immune modulators (including but not limited to anti-TNFα antibody and anti-IgE monoclonal antibody) within three months prior to Screening.
Subjects with a history of allergic reactions such as anaphylactic shock, angioedema with airway constriction, or hypotension caused by food other than peanut and/or medical products.
Subjects with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen/ antibody as determined at Screening.
Subjects who are immunocompromised, including those receiving immunosuppressive doses of corticosteroids (more than 20 mg of prednisone given daily or on alternate days for 2 weeks or more within 6 months prior to Screening, any dose of corticosteroids within 30 days of Screening, or high dose inhaled corticosteroids [> 960 μg/day of beclomethasone dipropionate or equivalent]) or other immunosuppressive agents.
Subjects with a history of unstable angina pectoris, cardiac disease or dysrhythmias, severe chronic lung disease, or any other chronic medical condition that which in the opinion of the investigator, would pose a significant health threat in the event of anaphylaxis/treatment of anaphylaxis.
Subjects with active eosinophilic esophagitis (EoE) or other eosinophilic gastrointestinal disease.
Subjects with clinically significant abnormality on electrocardiogram (ECG) at Screening that, in the investigator's opinion, makes the subject unsuitable for study participation.
Subjects with active malignancy, or history of malignancy or chemotherapy within the past 5 years other than history of localized or surgical removal of focal skin cancer, or cervical cancer in situ treated successfully in the past by local treatment (including but not limited to cryotherapy or laser therapy) or by hysterectomy.
Subjects with a mental condition such as schizophrenia, bipolar disorder, major depressive disorder, generalized anxiety disorder, panic disorder/attacks, or subjects who have received drug(s) for the treatment of dementia.
Subjects with severe or poorly controlled (resistant to appropriate medical intervention) atopic disease including atopic dermatitis, generalized eczema, allergic rhinitis and/or urticaria.
Subjects with tryptase values outside of the normal reference range.
Subjects with severe or uncontrolled/difficult to control asthma/wheezing, defined by at least one of the following criteria:
Subjects who have received an investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to Screening.
Subjects with any condition which, in the investigator's opinion, makes the subject unsuitable for study participation: Past or current medical problems, history of other chronic diseases requiring therapy, findings from physical assessment, or abnormalities in clinical laboratory testing that are not listed above, which in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.
Subjects with a known sensitivity to any components of CNP-201 (PLGA, sucrose, mannitol, or sodium citrate).
Primary purpose
Allocation
Interventional model
Masking
15 participants in 5 patient groups, including a placebo group
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Central trial contact
Jerry Staser
Data sourced from clinicaltrials.gov
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