Safety, Tolerability, PK, PD of ADX-324 in Healthy Volunteers and Hereditary Angioedema Patients

Last updated: April 10, 2025
Sponsor: ADARx Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Urticaria

Hives (Urticaria)

Allergy

Treatment

ADX-324

Placebo

Clinical Study ID

NCT05691361
ADX-324-101
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The first-in-human Phase 1 study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-324 in healthy volunteers (HV) and in patients with Hereditary Angioedema (HAE).

Eligibility Criteria

Inclusion

Part A - HV

Inclusion Criteria:

  1. Male and female adults 18 to 55 years old

  2. Body mass index (BMI) between 18 and 30 kg/m2

  3. Contraception use by men or women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies

  4. Willing and able to provide informed consent and comply with all study visits

Exclusion

Exclusion Criteria:

  1. Any significant medical history

  2. Active malignancy and/or history of malignancy in the past 5 years

  3. History of liver disease, Gilbert's syndrome, or abnormal liver function test

  4. Estimated creatinine clearance <60 mL/min or serum creatinine > 1.5-fold upper limitof normal.

  5. Any active infection or acute illness

  6. Major surgery or significant traumatic injury occurring within 3 months

  7. 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.

  8. Positive serology tests (HepB, Hep C, HIV)

  9. Use of any prescription, vaccines, supplements/vitamins, or over-the countermedication

  10. Treatment with another investigational product within 30 days prior to the firststudy drug administration

  11. Known any clinically significant allergic reactions which, in the opinion of theInvestigator, would interfere with the volunteer's ability to participate in thestudy

  12. Known hypersensitivity to any of the study drug ingredients.

  13. Pregnancy, intent to become pregnant during the course of the study, or lactatingwomen

Part B - HAE

Inclusion Criteria:

  1. Male and female ≥18 years old, inclusive, at the time of signing the PICF

  2. Confirmed diagnosis of HAE Types I or II

  3. Evidence of an average of (at least) one HAE attack per month

  4. Participants must have access to, and the ability to use, acute medication(s) totreat angioedema attacks.

  5. Body mass index (BMI) between 18 and 30 kg/m2

  6. Contraception use by men or women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies

  7. Willing and able to provide informed consent and comply with all study visits

Exclusion Criteria:

  1. Concurrent diagnosis of any other type of chronic angioedema

  2. History of clinically significant arterial or venous thrombosis, or current historyof a clinically significant prothrombotic risk.

  3. Any significant medical history

  4. Active malignancy and/or history of malignancy in the past 5 years

  5. Any active infection or acute illness, inclusive of cold/flu or COVID-19, within 30days prior to the first study drug administration.

  6. Major surgery or significant traumatic injury occurring within 3 months prior tosignature of the PICF

  7. 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.

  8. Positive serology tests for human immunodeficiency virus (HIV), hepatitis B surfaceantigen (HBsAg), or hepatitis C virus (HCV).

  9. Use of C1-INH products, androgens, antifibrinolytics or other small moleculemedications for routine prophylaxis within four half-lives prior to screening

  10. Must have documented evidence of medical history of HAE attacks

  11. 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.

  12. Treatment with another investigational product or biologic agent within 30 daysprior to the study drug administration

  13. History or presence of alcohol abuse or drug use within 30 days prior to the firststudy drug administration and throughout the study.

  14. 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.

  15. Pregnancy, intent to become pregnant during the course of the study, or lactatingwomen.

Study Design

Total Participants: 53
Treatment Group(s): 2
Primary Treatment: ADX-324
Phase: 1/2
Study Start date:
December 14, 2022
Estimated Completion Date:
January 31, 2026

Study Description

The clinical study described in this protocol is a Phase 1, single-center study evaluating safety, tolerability, PK, and PD of ADX-324.

The study consists of 2 parts:

  • Randomized, double-blind, placebo-controlled, parallel group, single ascending dose (SAD) in HV with up to 6 dose cohorts. For SAD cohorts and planned dosing; and,

  • Expansion cohort in participants with Hereditary Angioedema (HAE) at selected dose from Part A and will be open label.

Connect with a study center

  • CMAX Clinical Research

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

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