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VLP Peanut

Phase 1

Peanut Allergy | Monoclonal antibody | Immunology |cbdMD, Inc.|Last Updated: Mar 13, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

VLP Peanut · 1 trial · 1 indication

Phase 1 1
NCT05476497Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic SubjectsPeanut Allergy
ACTIVE NOT_RECRUITING46 Analytics
PHASE1ACTIVE NOT_RECRUITING
Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects
Peanut AllergyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number and severity of Adverse Events (AEs) (including local and systemic AEs).
Group A1: 18 weeks; Part B: 64 weeks (Part B). Group A2: 3 days.
Number of subjects discontinuing prematurely from treatment due to AEs
Group A1: 11 weeks Part B: 15 weeks

Secondary Endpoints

Incidence of fatigue (tiredness)
Group A1: 14 weeks Part B: 16 weeks
Frequency of fatigue (tiredness)
Group A1: 14 weeks Part B: 16 weeks
Incidence of headache
Group A1: 14 weeks Part B: 16 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A - Group A1EXPERIMENTAL4 parallel cohorts (1-4) of adult healthy subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut.
Part A - Group A2EXPERIMENTALAdult peanut allergic subjects, will undergo skin prick tests with ascending concentrations of VLP Peanut.
Part B - Cohorts 1-4EXPERIMENTAL4 parallel cohorts (1-4) of peanut allergic subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut.

Interventions

NameTypeDescription
VLP PeanutBIOLOGICALsolution for subcutaneous administration
PlaceboBIOLOGICALsolution for subcutaneous administration
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites10

Part A Main Inclusion Criteria: 1. Capable of giving signed informed consent. 2. Subject who has a signed and dated Informed Consent Form (ICF). 3. Subject must be 18 to 50 years inclusive, at the time of signing the ICF. 4. Male or female. 5. Female subjects who are not of childbearing potential (...

Countries:United States
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Frequently asked questions about VLP Peanut

What is VLP Peanut used for?

VLP Peanut is an investigational monoclonal antibody being developed for the treatment of peanut allergy. It is currently in Phase 1 clinical development and is not yet approved by the FDA. The drug is being studied in both healthy volunteers and individuals with peanut allergy.

Who makes VLP Peanut?

VLP Peanut is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker symbol YCBD. The company is conducting clinical trials to evaluate the safety and efficacy of VLP Peanut for peanut allergy.

What phase is VLP Peanut in?

VLP Peanut is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is actively enrolling participants, though recruitment is not currently open.

What clinical trials is VLP Peanut in?

VLP Peanut is being studied in a Phase 1 clinical trial registered as NCT05476497, titled 'Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects.' The trial is active but not recruiting, with an enrollment of 46 participants in the United States.

Is VLP Peanut a monoclonal antibody?

Yes, VLP Peanut is a monoclonal antibody. It is being developed as an investigational treatment for peanut allergy and is currently in Phase 1 clinical trials. The drug is being evaluated in a controlled, randomized, double-blind study.