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

NCT04060173 | Completed Phase 1 FDA Drug

• 1 other identifier: ABP-671-102
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Keywords

Gout; Hyperuricemia

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (AEs)

  Measured by the number of patients with AEs

  38 days

Secondary Outcomes (7)

• 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

Study Arms (2)

Treatment with ABP-671

EXPERIMENTAL

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

Drug: ABP-671

Treatment with placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

ABP-671 DRUG

ABP-671 is an investigational drug

Treatment with ABP-671

Placebo OTHER

Matching placebo

Treatment with placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atom Therapeutics Co., Ltd: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Hyperuricemia; Gout

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Danielle Armas, MD

  Celerion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 19, 2019
• Study Start: September 5, 2019
• Primary Completion: December 29, 2019
• Study Completion: February 7, 2020
• Last Updated: February 12, 2020

Record last verified: 2020-02

Locations

US (1)