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

NCT ID: NCT04060173

Last Updated: 2020-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-05
• Study Completion Date: 2020-02-07

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.

Conditions

Hyperuricemia; Gout

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment with ABP-671

Three sequential dose escalation cohorts of ABP-671 administered orally for 10 days.

Group Type: EXPERIMENTAL

ABP-671

Intervention Type: DRUG

ABP-671 is an investigational drug

Treatment with placebo

Three sequential dose escalation cohorts of ABP-671 matching placebo administered orally for 10 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Matching placebo

Interventions

ABP-671

ABP-671 is an investigational drug

Intervention Type: DRUG

Placebo

Matching placebo

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Atom Therapeutics Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielle Armas, MD

Role: PRINCIPAL_INVESTIGATOR

Celerion

Locations

Celerion

Tempe, Arizona, United States

Countries

United States

Other Identifiers

ABP-671-102

Identifier Type: -

Identifier Source: org_study_id