A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Phase 1b Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 Administered Orally for 10 Days in Subjects With Hyperuricemia

Conditions
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Hyperuricemia, Gout

Intervention / Treatment
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* Drug: ABP-671
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with ABP-671<br>Three sequential dose escalation cohorts of ABP-671 administered orally for 10 days. | Drug: ABP-671<br>* ABP-671 is an investigational drug<br>|
| Placebo Comparator: Treatment with placebo<br>Three sequential dose escalation cohorts of ABP-671 matching placebo administered orally for 10 days. | Other: Placebo<br>* Matching placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) | Measured by the number of patients with AEs | 38 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration of ABP-671 (Cmax) |  | 2 weeks | 
| Area under time-concentration curve (AUC) |  | 2 weeks | 
| 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 | 
| The effect of ABP-671 versus placebo on the percent change from baseline in serum uric acid |  | 24 days | 
| The effect of ABP-671 versus placebo on change in urine uric acid excretion |  | 24 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gout, Hyperuricemia