Health TrialsbyHealthPanel

Study of ENP-501 in Peanut-Allergic and Non-Allergic Participants

ConditionPeanut Allergy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age14-50
SponsorN-Fold, LLC

About this trial

This is a Phase 1/2 study to evaluate the safety and clinical activity of ENP-501 in non-peanut allergic (NPA) healthy participants and participants with an established peanut allergy (PA)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

14-50 years of age (inclusive)

Otherwise medically healthy and able to participate in the study

Able to perform spirometry testing in accordance with the American Thoracic Society (ATS) guidelines (2019)

All women of child-bearing potential, agree to either abstain from sexual activity or agree to use an adequate method of contraception for the duration of the study and for 30 days after the last dose of investigational product

Disqualifiers

History of severe anaphylactic event requiring mechanical ventilation or use of intravenous (IV) vasopressor drugs

Clinically significant screening electrocardiogram (ECG) abnormality or corrected QTcF >/= 450 msec at Screening

FEV1 value < 80% predicted at Screening

Any hospitalization in the past year for asthma, >1 course of oral steroids for asthma in the past 6 months, or any emergency room visit in the past 6 months for asthma

Trial design

Design model

Parallel

Treatments tested in this trial

  • ENP-501

    Drug

    * Part 1: Participants will receive buccal administrations of ENP-501 daily for 6-14 weeks * Part 2: Participants will receive buccal administrations of ENP-501 daily for 52 weeks following achieving the 2000 µg target dose

  • Placebo

    Drug

    * Part 1: Participants will receive buccal administrations of placebo daily for 6-14 weeks * Part 2: Participants will receive buccal administrations of placebo daily for 52 weeks following achieving the 2000 µg target dose

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: ENP-501Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI CTCAE v 5.0 in Part 1

Time frame
Up to 22 Weeks
2

Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) as Assessed by NCI CTCAE v 5.0 in Part 1

Time frame
Up to 22 Weeks
3

Number of Participants with Dose Limiting Toxicities (DLTs) as Assessed by NCI CTCAE v 5.0 in Part 1

Time frame
Up to 22 Weeks
4

Number of Participants with Systemic Reactions as Assessed by NCI CTCAE v 5.0 in Part 1

Time frame
Up to 22 Weeks

Secondary outcomes

1

Number of Participants Able to Tolerate 2000 µg Dose of ENP-501 Without Experiencing Dose-Limiting Toxicity (DLT) in Part 1

Time frame
Up to 22 Weeks
2

Change in Total IgE Levels in Part 1

Time frame
Screening and Week 22 (EOS)
3

Change in Ara h 1-Specific IgE Levels in Part 1

Time frame
Screening and Week 22 (EOS)
4

Change in Ara h 2-Specific IgE Levels in Part 1

Time frame
Screening and Week 22 (EOS)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

N-Fold, LLC

Lead sponsor

CBCC Global Research

Collaborator

Source ClinicalTrials.gov
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