A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 in Healthy Subjects

A Single-Center, Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Oral Doses of ABP-671 in Healthy Volunteers in the United States

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of ABP-671 administered orally in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Hyperuricemia; Gout
• Intervention / Treatment: Drug: ABP-671; Other: Placebo

Detailed Description

Primary Objectives:

• To assess the safety and tolerability of single ascending oral doses of ABP-671 in Healthy Volunteers (HVs).

Secondary Objectives:

• To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of single ascending oral doses of ABP-671 in HVs.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. Healthy (no clinically significant health concerns), as determined by medical history, physical examination, 12-lead ECG, and vital signs.
2. Participants serum uric acid level at screening ≥ 4.0 mg/dL to ≤ 5.5 mg/dL for males, and ≥ 4.0 mg/dL to ≤ 5.0 mg/dL for females.
3. Participants must have a body mass index (BMI) between 18 and 32 kg/m2 and a body weight of 50 kg or higher.
4. Participants must have normal blood chemistry or results considered not clinically significant by the investigator including electrolytes, alkaline phosphatase, total protein, albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, uric acid, creatinine, blood urea nitrogen (BUN), and glucose at Screening Visit and at Pre-dose Visit.
5. Participants are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study.

Exclusion Criteria

1. Participants with any history or clinical manifestations of significant metabolic, hematological, pulmonary, including latent tuberculosis, cardiovascular, gastrointestinal including cholecystectomy, neurologic, hepatic, renal, urological, or psychiatric disorders.
2. Participants who have any history or suspicion of kidney stones.
3. Participants who have used prescription drugs, over-the-counter drugs, or herbal remedies within 14 days before Day 1 of study medication dosing. Females who have received hormone replacement therapy (HRT) within 28 days prior to dosing.
4. Women who are pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABP-671, Cohort 1-; ABP-671, Cohort 1 participants received 50 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).	Drug: ABP-671; Drug: ABP-671, single oral dose; Other: Placebo; Other: Placebo, single oral dose
Experimental: ABP-671, Cohort 2-; ABP-671, Cohort 2 participants will receive 0.1 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).	Drug: ABP-671; Drug: ABP-671, single oral dose; Other: Placebo; Other: Placebo, single oral dose
Experimental: ABP-671, Cohort 3-; ABP-671, Cohort 3 participants will receive 0.5 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).	Drug: ABP-671; Drug: ABP-671, single oral dose; Other: Placebo; Other: Placebo, single oral dose
Experimental: ABP-671, Cohort 4-; ABP-671, Cohort 4 participants will receive 1.0 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).	Drug: ABP-671; Drug: ABP-671, single oral dose; Other: Placebo; Other: Placebo, single oral dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Incidence of adverse events	baseline to 7 days
Maximum tolerable dose	Maximum tolerable dose	baseline to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak plasma concentration	Peak plasma concentration	baseline to 72 hours
half-life	half-life	baseline to 72 hours
area under the curve	area under the curve	baseline to 72 hours
volume of distribution	volume of distribution	baseline to 72 hours
level of serum and urine uric acid	level of serum and urine uric acid	baseline to 72 hours
level of serum and urine creatinine	level of serum and urine creatinine	baseline to 72 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2018
• Primary Completion (Actual): June 20, 2019
• Study Completion (Actual): June 20, 2019

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (Actual): April 8, 2019

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: gout; hyperuricemia
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia
• Other Study ID Numbers: ABP-671-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No