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

Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.1 site in 1 country27 target enrollmentSeptember 5, 2019

ConditionsHyperuricemia Gout

InterventionsABP-671 Placebo

DrugsABP-671

Overview

Phase: Phase 1
Intervention: ABP-671
Conditions: Hyperuricemia
Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
Enrollment: 27
Locations: 1
Primary Endpoint: Incidence of Adverse Events (AEs)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 5, 2019

End Date

February 7, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

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.

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
•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.

Arms & Interventions

Treatment with ABP-671

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

Intervention: ABP-671

Treatment with placebo

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

Intervention: Placebo

Outcomes

Primary Outcomes

Incidence of Adverse Events (AEs)

Time Frame: 38 days

Measured by the number of patients with AEs

Secondary Outcomes

Area under time-concentration curve (AUC)(2 weeks)
Maximum observed plasma concentration of ABP-671 (Cmax)(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)
Time of maximum observed plasma concentration of ABP-671 (Tmax)(2 weeks)