Phase
Condition
Urticaria
Hives (Urticaria)
Allergy
Treatment
ADX-324
Placebo
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Part A - HV
Inclusion Criteria:
Male and female adults 18 to 55 years old
Body mass index (BMI) between 18 and 30 kg/m2
Contraception use by men or women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies
Willing and able to provide informed consent and comply with all study visits
Exclusion
Exclusion Criteria:
Any significant medical history
Active malignancy and/or history of malignancy in the past 5 years
History of liver disease, Gilbert's syndrome, or abnormal liver function test
Estimated creatinine clearance <60 mL/min or serum creatinine > 1.5-fold upper limitof normal.
Any active infection or acute illness
Major surgery or significant traumatic injury occurring within 3 months
Have any other conditions that, in the opinion of the Investigator or Sponsor, wouldmake the participant unsuitable for inclusion, or could interfere with theparticipant participating in or completing the study.
Positive serology tests (HepB, Hep C, HIV)
Use of any prescription, vaccines, supplements/vitamins, or over-the countermedication
Treatment with another investigational product within 30 days prior to the firststudy drug administration
Known any clinically significant allergic reactions which, in the opinion of theInvestigator, would interfere with the volunteer's ability to participate in thestudy
Known hypersensitivity to any of the study drug ingredients.
Pregnancy, intent to become pregnant during the course of the study, or lactatingwomen
Part B - HAE
Inclusion Criteria:
Male and female ≥18 years old, inclusive, at the time of signing the PICF
Confirmed diagnosis of HAE Types I or II
Evidence of an average of (at least) one HAE attack per month
Participants must have access to, and the ability to use, acute medication(s) totreat angioedema attacks.
Body mass index (BMI) between 18 and 30 kg/m2
Contraception use by men or women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies
Willing and able to provide informed consent and comply with all study visits
Exclusion Criteria:
Concurrent diagnosis of any other type of chronic angioedema
History of clinically significant arterial or venous thrombosis, or current historyof a clinically significant prothrombotic risk.
Any significant medical history
Active malignancy and/or history of malignancy in the past 5 years
Any active infection or acute illness, inclusive of cold/flu or COVID-19, within 30days prior to the first study drug administration.
Major surgery or significant traumatic injury occurring within 3 months prior tosignature of the PICF
Have any other conditions that, in the opinion of the Investigator or Sponsor, wouldmake the participant unsuitable for inclusion, or could interfere with theparticipant participating in or completing the study.
Positive serology tests for human immunodeficiency virus (HIV), hepatitis B surfaceantigen (HBsAg), or hepatitis C virus (HCV).
Use of C1-INH products, androgens, antifibrinolytics or other small moleculemedications for routine prophylaxis within four half-lives prior to screening
Must have documented evidence of medical history of HAE attacks
Use of any prescription, vaccines, supplements/vitamins, or over-the countermedication (with the exception of oral contraceptives) within 7 days prior to thefirst study drug administration.
Treatment with another investigational product or biologic agent within 30 daysprior to the study drug administration
History or presence of alcohol abuse or drug use within 30 days prior to the firststudy drug administration and throughout the study.
Blood donation of 50 to 499 mL within 30 days prior to the first study drugadministration or of >499 mL within 60 days prior to the first study drugadministration.
Pregnancy, intent to become pregnant during the course of the study, or lactatingwomen.
Study Design
Study Description
Connect with a study center
CMAX Clinical Research
Adelaide, South Australia 5000
AustraliaActive - Recruiting
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