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

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04060173
• Other study ID #: ABP-671-102
• Status: Completed
• Phase: Phase 1
• Start date: September 5, 2019
• Est. completion date: February 7, 2020

Study information

• Verified date: February 2020
• Source: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 7, 2020
• Est. primary completion date: December 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gout
• Hyperuricemia

Intervention

Drug:
• ABP-671
ABP-671 is an investigational drug

Other:
• Placebo
Matching placebo

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AEs)	Measured by the number of patients with AEs	38 days
Secondary	Maximum observed plasma concentration of ABP-671 (Cmax)		2 weeks
Secondary	Area under time-concentration curve (AUC)		2 weeks
Secondary	Time of maximum observed plasma concentration of ABP-671 (Tmax)		2 weeks
Secondary	Volume of distribution (Vd)		2 weeks
Secondary	Half life of ABP-671 (t1/2)		2 weeks
Secondary	The effect of ABP-671 versus placebo on the percent change from baseline in serum uric acid		24 days
Secondary	The effect of ABP-671 versus placebo on change in urine uric acid excretion		24 days