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

• Status: Completed
• Trial end date: 2020-02-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Criteria

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.