Gout, Hyperuricemia
Conditions
Keywords
Gout, Hyperuricemia
Brief summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of ABP-671 administered orally in subjects with hyperuricemia.
Interventions
OTHERPlacebo
Matching placebo
DRUGABP-671
ABP-671 is an investigational drug
Sponsors
Atom Therapeutics Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must be medically documented as healthy and acceptable at screening. * Subjects must have serum uric acid level at screening ≥ 7.0 mg/dL for men, ≥ 6.0 mg/dL for women. * Subjects must have a Body Mass Index (BMI) between 18.0 and 34.0 kg/m2 (inclusive). * Subjects must have a body weight of 50 kg or higher. * The subject agrees to abstain from alcohol consumption for 48 hours prior to dosing, for the duration of the in-house study period, and for 48 hours prior to each in-clinic follow up visit. * The subject is a nonsmoker. * Women must be non-pregnant and non-lactating, and either surgically sterile or postmenopausal for ≥ 12 months. * Men must be surgically sterile, abstinent or if engaged in sexual relations with a female partner of child-bearing potential, the participant must be using a condom with spermicide from Screening and for a period of 30 days after the last dose of Study Drug. The Investigator will assess the adequacy of methods of contraception on a case-by-case basis. * Subjects must have a complete blood count (CBC) and platelet count within the normal range or considered not clinically significant by the principal investigator. * Other than elevated serum uric acid, subjects must have normal blood chemistry or results considered not clinically significant by the investigator. * Subjects must have a normal urinalysis or results considered not clinically significant by the investigator including a normal protein/creatinine ratio per local lab reference ranges (≤ 200 mg/g) and a urine creatinine result that does not exceed 300 mg/dL. Any out of range values may be repeated per Investigator discretion. * Subjects must have a normal ECG or results considered not clinically significant by the principal investigator. * Subjects must be able to comply with the study and follow-up procedures. * Subjects are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study.
Exclusion criteria
* Subjects with any history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders. * Subjects who are positive for human immunodeficiency virus (HIV), Hepatitis B surface antigen, and/or Hepatitis C virus. * Subjects who have used prescription drugs, over-the-counter drugs, or herbal remedies within 3 weeks before Day 1 of study medication dosing. * Subjects who are positive for urine drug and alcohol screening tests. * Subjects who have undergone major surgery within 3 months prior to Day 1. * Women who are pregnant or breastfeeding. * Subjects who received any investigational test article within 5 half-lives or 30 days, whichever is longer, prior to Day 1 study medication dosing. * Recent blood donation for more than 500 mL within 2 months of screening. * Abnormal ECG including QTc \> 470 (F) and \> 450 (M). * Subjects who consumed Seville oranges- or grapefruit-containing foods or beverages within 7 days before Day 1 and during the entire study duration. * Subjects with any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study. * Prior exposure to ABP-671.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events (AEs) | 38 days | Measured by the number of patients with AEs |
Secondary
| Measure | Time frame |
|---|---|
| Time of maximum observed plasma concentration of ABP-671 (Tmax) | 2 weeks |
| Volume of distribution (Vd) | 2 weeks |
| Half life of ABP-671 (t1/2) | 2 weeks |
| Area under time-concentration curve (AUC) | 2 weeks |
| The effect of ABP-671 versus placebo on change in urine uric acid excretion | 24 days |
| Maximum observed plasma concentration of ABP-671 (Cmax) | 2 weeks |
| The effect of ABP-671 versus placebo on the percent change from baseline in serum uric acid | 24 days |
Countries
United States
Outcome results
None listed