Clinical Trials

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 (or females of childbearing
potential who agree to comply with the contraceptive requirements of the clinical
trial protocol).

6. Good general health, as determined by the Investigator.

7. A positive SPT to histamine.

The following additional inclusion criteria are only applicable to the healthy
subjects in Group A1:

8. Healthy subjects (non-atopic) with no clinically significant co-morbidity (including
broncho-reactive airway disease like asthma, current allergic rhinitis, etc.).

9. Subjects with no history of allergy or intolerance to peanut or any other food and who
consume peanuts with no effect.

10. Subjects with lack of sensitivity to peanut allergen confirmed by SPT using whole
peanut extract.

11. Peanut specific immunoglobulin E (IgE) <0.1 kU/L.

12. Ara h 2 specific IgE <0.1 kU/L.

13. Subjects with negative basophil activation test (BAT).

The following additional inclusion criteria are only applicable to the subjects with
PA in Group A2:

14. Clinical history of physician diagnosed PA.

15. Peanut allergen sensitivity confirmed by SPT and IgE.

16. Subjects who currently adhere to a strict peanut-free diet and who agree to continue
this for the duration of the clinical trial.

17. Subjects who are able to handle and correctly use an adrenaline auto-injector.

Part B Main Inclusion Criteria:

1. Capable of giving signed informed consent.

2. Subject who has a signed and dated ICF.

3. Subjects aged 18 to 50 years of age inclusive, at the time of signing the ICF.

4. Male or female.

5. 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).

6. Clinical history of physician diagnosed PA.

7. Peanut allergen sensitivity confirmed by SPT and IgE (Peanut specific IgE ≥5.0 kU/L
and Ara h 2 specific IgE ≥2.0 kU/L)

8. Subjects with positive BAT.

9. Subjects who currently adhere to a strict peanut-free diet and who agree to continue
this for the duration of the clinical trial.

10. Good general health, as determined by the Investigator.

11. Subjects who are able to handle and correctly use an adrenaline auto-injector.

Main Exclusion Criteria Part A and B:

1. Pregnant or lactating subject.

2. Presence of any medical condition that may reduce the ability to survive a serious
allergic reaction.

3. Subjects with atopic dermatitis with >25% skin surface involvement.

4. For subjects with PA, presence of severe, poorly controlled or uncontrolled asthma.

5. History of severe or life-threatening anaphylactic reactions to peanut resulting in
neurological compromise or requiring mechanical ventilation.

6. Clinical history of severe systemic or life-threatening anaphylactic reactions to
other foods (apart from peanut), insect venom, exercise, drugs, etc. or idiopathic
anaphylaxis.

7. Unable to receive epinephrine therapy or at greater risk of developing adverse
reactions after epinephrine administration as assessed by the site Investigator.

8. 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.

9. Participation in a clinical research trial with any investigational drug/placebo
within 3 months of screening (Visit 1) or concomitantly with this clinical trial.

10. Personal, financial or other dependent relationship (e.g., employee or immediate
relative) with the clinical trial site, Sponsor, Sponsor's representative, or another
individual who has access to the clinical trial protocol.

11. Vulnerable subjects or those in judicial or governmental detention, detainment or
imprisonment in a public institution.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/19/24. Questions regarding updates should be directed to the study team contact.