Active — Not RecruitingPhase 1/2

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

Australia53 participantsStarted 2022-12-14

Plain-language 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).

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 regulations regarding 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

✕. 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 limit of 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, would make the participant unsuitable for inclusion, or could interfere with the participant participating in or completing the study.
✕. Positive serology tests (HepB, Hep C, HIV)

What they're measuring

Safety in Healthy Volunteers

Timeframe: 365 days

Safety in Healthy Volunteers

Timeframe: 365 days

Safety in Hereditary Angioedema

Timeframe: 365 days

Trial details

NCT IDNCT05691361

SponsorADARx Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-31

View on ClinicalTrials.gov More Hereditary Angioedema trials

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 regulations regarding 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

✕. 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 limit of 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, would make the participant unsuitable for inclusion, or could interfere with the participant participating in or completing the study.
✕. Positive serology tests (HepB, Hep C, HIV)