Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||16 Years - 55 Years|
Inclusion Criteria:1. Men and non-pregnant women, ages 16 to 55 years inclusive. 2. Subjects with physician-diagnosed peanut allergy or documented history of peanut allergy. 3. Subjects with weight ≥ 31.25 kg at Screening. Subjects who fall outside of this range may be included at the discretion of the investigator. 4. Subjects with a documented history of non-severe anaphylaxis (Grade ≤ 3) to peanuts, including mild wheezing or dyspnea without hypoxia. 5. Subjects with peanut specific IgE > 5 kU/L as measured by ImmunoCAP at Screening. Subjects who have previously been on OIT for peanut allergy and who do not have peanut specific IgE ≥ 5 kU/L as measured by ImmunoCAP at Screening may be included at the discretion of the investigator. 6. Subjects who are self-reported to be on a peanut free diet with no suspected peanut exposure, including any peanut food challenge, for at least 14 days prior to Screening and agreement to continue restriction to peanut exposure during the study. 7. Subjects with a positive skin prick test (SPT) to peanut with a change in wheal diameter ≥ 3 mm as compared to a negative control (50% glycerin) at Screening. Subjects who have previously been on OIT for peanut allergy and who do not have a positive skin prick test (SPT) to peanut with a change in wheal diameter ≥ 3 mm at Screening may be included at the discretion of the investigator. 8. Female subjects and male subjects and their female spouse/partners who are willing to practice a highly effective method of contraception that may include, but is not limited to, abstinence, sex only with persons of the same sex, monogamous relationship with vasectomized partner, vasectomy, hysterectomy, bilateral tubal ligation, licensed hormonal methods, intrauterine device (IUD), or use of spermicide combined with a barrier method (e.g., condom, diaphragm) starting at Screening and continuing to Day 38. 9. Female subjects who agree to not breastfeed starting at initial Screening and continuing to Day 38. 10. Female subjects who agree to not donate ova starting at initial Screening and continuing to Day 38.. 11. Subjects who are willing and able to provide Institutional Review Board (IRB) approved written informed consent. 12. Subjects who are willing to perform and comply with all study procedures. 13. Male subjects who agree to not donate sperm starting at Screening and continuing to Day 38.
Exclusion Criteria:1. Subjects with history of severe anaphylaxis to peanuts defined as neurological compromise or requiring intubation. 2. Subjects who have received administration of vaccinations in the following timeframe:
- - Any live vaccine (other than intranasal Influenza) within 28 days prior to Screening.
- - Any subunit vaccine within 14 days prior to Screening.
- - Global Initiative for Asthma (GINA) 2020: Personalized management to control symptoms and minimize future risk requiring treatment Steps 4 or 5 (Appendix 3) OR; - Forced expiratory volume in 1 second (FEV1) < 80% of predicted, or ratio of FEV1 to forced vital capacity (FEV1/FVC) < 75% of predicted, with or without controller medications (only those able to reliable perform spirometry.
- - One overnight admission to a hospital in the past year for asthma OR; - Emergency room visit for asthma within 6 months prior to Screening OR; - History of two or more systemic corticosteroid courses within 6 months of Screening or one course of systemic corticosteroids within 3 months of Screening to treat asthma/wheezing OR; - Prior intubation/mechanical ventilation for asthma/wheezing.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Phase 1/Phase 2|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|COUR Pharmaceutical Development Company, Inc.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Greta Wodarcyk, PhD|
|Principal Investigator Affiliation||COUR Pharmaceuticals|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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 changes. Subjects will continue to be followed for safety, and tolerability during the 172-day Post-Dosing period (up to Study Day 180). 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. On Day 90 and Day 120, subjects will return to the clinic for collection of immune safety labs, and PD measurements. Subjects will 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.
Experimental: CNP-201 25 mg
200 mL intravenous infusion on Day 1 and Day 8: 25 mg CNP-201
Experimental: CNP-201 TBD(1) mg
200 mL intravenous infusion on Day 1 and Day 8: TBD mg CNP-201
Experimental: CNP-201 TBD(2) mg
200 mL intravenous infusion on Day 1 and Day 8: TBD mg CNP-201
Placebo Comparator: Placebo
200 ml intravenous infusion on Day 1 and Day 8: CNP-201 Placebo
Drug: - CNP-201
CNP-201 is comprised of purified peanut extract (PPE) drug substance dispersed within a negatively charged polymer matrix of poly (lactic-co-glycolic acid) (PLGA) particles at a target concentration of ~5 μg of PPE per mg of PLGA.
Drug: - Placebo
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.