Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT04987294
Eligibility Criteria:
Inclusion Criteria:
* Male or female, age 18 to 70 years
* Serum UA level ≥ 8.0 mg/dL at Screening (hyperuricemia)
* Meets 2015 American College of Rheumatology (ACR)/EULAR criteria for gout
* Screening eGFR of ≥60 - \<90 mL/minute/1.73 m2 for Cohort A and ≥30 - \<60 mL/minute/1.73 m2 for Cohort B.
* Concomitant medications stable for a minimum of 4 weeks prior to and during Screening
* Body Mass Index (BMI) ≥ 18 and ≤ 40 kg/m2, inclusive, at screening
* Not pregnant, not capable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation
Exclusion Criteria:
* Currently taking any oral urate-lowering medication within 2 weeks prior to Screening
* Prior uricase therapy or exposure to recombinant uricase, such as Rasburicase or Pegloticase
* Gout flare requiring treatment within 14 days prior to or during Screening
* Clinically significant finding during Screening, any ongoing clinically significant illness requiring a clinically significant intervention or change in management within 4 weeks prior to or during Screening
* History of GI surgery, including gastric sleeve, Roux-en-Y or gastric banding (unless gastric band removed for a minimum of 12 months prior to Screening
* Received treatment with or exposure to an Investigational drug or device within 30 days - prior to or during Screening
* Prior dosing in ALLN-346 clinical study
* Per Investigator judgment, is not an ideal clinical study candidate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04987294
Study Brief:
Protocol Section:
NCT04987294