Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects (NCT05476497) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects
United States46 participantsStarted 2022-10-17
Plain-language summary
This phase I clinical trial is designed to evaluate the safety and tolerability of VLP Peanut in healthy subjects and in subjects with peanut allergy (PA). This clinical trial will evaluate the immunotoxicity profile of VLP Peanut in healthy subjects and assess the immunotoxicity profile and the degree of reactogenicity (allergenicity) in subjects with PA. This clinical trial will also explore preliminary proof of efficacy of VLP Peanut in subjects with PA.
Who can participate
Age range18 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Capable of giving signed informed consent.
✓. Subject who has a signed and dated Informed Consent Form (ICF).
✓. Subject must be 18 to 50 years inclusive, at the time of signing the ICF.
✓. Male or female.
✓. Female subjects who are not of childbearing potential (or females of childbearing potential who agree to comply with the contraceptive requirements of the clinical trial protocol).
✓. Good general health, as determined by the Investigator.
✓. A positive SPT to histamine.
✓. Healthy subjects (non-atopic) with no clinically significant co-morbidity (including broncho-reactive airway disease like asthma, current allergic rhinitis, etc.).
Exclusion criteria
✕. Pregnant or lactating subject.
✕. Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
✕. Subjects with atopic dermatitis with \>25% skin surface involvement.
✕. For subjects with PA, presence of severe, poorly controlled or uncontrolled asthma.
✕. History of severe or life-threatening anaphylactic reactions to peanut resulting in neurological compromise or requiring mechanical ventilation.
What they're measuring
1
Number and severity of Adverse Events (AEs) (including local and systemic AEs).
Timeframe: Group A1: 18 weeks; Part B: 64 weeks (Part B). Group A2: 3 days.
2
Number of subjects discontinuing prematurely from treatment due to AEs
✕. History of severe or life-threatening anaphylactic reactions to foods (excluding peanuts), insect venom, exercise, drugs, or idiopathic causes, resulting in neurological compromise or requiring mechanical ventilation or deemed severe as per Investigator assessment.
✕. Unable to receive epinephrine therapy or at greater risk of developing adverse reactions after epinephrine administration as assessed by the site Investigator.
✕. Clinical history of drug or alcohol abuse, which, in the Investigator's opinion, could interfere with the subject's ability to participate in the clinical trial.