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CNP-201 for Peanut Allergy
Phase 1
Waitlist Available
Research Sponsored by COUR Pharmaceutical Development Company, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1 pre-dose) through day 60, an average of 52 days
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and effective.
Who is the study for?
This trial is for men and women aged 16-55 with a physician-diagnosed peanut allergy or documented history of it. They must weigh at least 31.25 kg, have been on a peanut-free diet for at least 14 days prior to screening, and agree to avoid peanuts during the study. Participants need a specific level of peanut-specific IgE or positive skin test results for peanuts. Women can't be pregnant or breastfeeding, and all participants must use effective contraception.Check my eligibility
What is being tested?
The trial is testing CNP-201 against a placebo in people with peanut allergies over multiple doses to find a safe amount that's tolerable. It has two phases: an Escalation Phase to determine the right dose levels, followed by an Expansion Phase where these levels are tested on more subjects.See study design
What are the potential side effects?
Potential side effects aren't detailed here but generally could include reactions typical of new medications such as discomfort at injection site, allergic reactions, gastrointestinal issues like nausea or diarrhea, headaches, fatigue, or other immune-related responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1 pre-dose) through day 60, an average of 52 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1 pre-dose) through day 60, an average of 52 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Serum Cytokines (TNF-α, IL-2, IL-6, IL-8, IL-1β, MCP-1, MIP-1β, MIP-1α, IFN-γ, and IL-12p70)
Secondary outcome measures
Change in peanut specific IgE between CNP-201 and Placebo
Change in the effective concentration at 50% of maximal basophil activation (EC50)
Regulatory T-Lymphocytes
+3 moreTrial Design
5Treatment groups
Experimental Treatment
Placebo Group
Group I: CNP-201 8 mgExperimental Treatment1 Intervention
intravenous infusion on Day 1 and Day 8: 8 mg CNP-201
Group II: CNP-201 4 mgExperimental Treatment1 Intervention
intravenous infusion on Day 1 and Day 8: 4 mg CNP-201
Group III: CNP-201 2 mgExperimental Treatment1 Intervention
intravenous infusion on Day 1 and Day 8: 2 mg CNP-201
Group IV: CNP-201 1 mgExperimental Treatment1 Intervention
intravenous infusion on Day 1 and Day 8: 1 mg CNP-201
Group V: PlaceboPlacebo Group2 Interventions
200 ml intravenous infusion on Day 1 and Day 8: CNP-201 Placebo
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Who is running the clinical trial?
COUR Pharmaceutical Development Company, Inc.Lead Sponsor
4 Previous Clinical Trials
128 Total Patients Enrolled
Jerry StaserStudy DirectorCOUR Pharmaceuticals
1 Previous Clinical Trials
9 Total Patients Enrolled
Greta Wodarcyk, PhDStudy DirectorCOUR Pharmaceuticals
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced severe allergic reactions in the past, like difficulty breathing, swelling, or low blood pressure, due to food or medications other than peanuts.You have a condition called eosinophilic esophagitis or another similar condition affecting your gastrointestinal system.You have a severe or uncontrolled allergic condition like eczema, hay fever, or hives that does not respond well to treatment.You have a history of serious heart or lung problems, or any other chronic medical condition that could be dangerous if you had a severe allergic reaction or needed treatment for an allergic reaction.You have a mental condition like schizophrenia, bipolar disorder, major depressive disorder, or anxiety disorder. You have also taken medication for dementia treatment.You have experienced a severe allergic reaction to peanuts in the past, which caused serious symptoms like difficulty breathing or needing a breathing tube.You have had a previous allergic reaction to peanuts, but it was not severe.
Research Study Groups:
This trial has the following groups:- Group 1: CNP-201 1 mg
- Group 2: CNP-201 2 mg
- Group 3: CNP-201 4 mg
- Group 4: CNP-201 8 mg
- Group 5: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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