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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Gout, Hyperuricemia

Intervention / Treatment
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* Drug: ABP-671
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Healthy (no clinically significant health concerns), as determined by medical history, physical examination, 12-lead ECG, and vital signs. 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. Participants must have a body mass index (BMI) between 18 and 32 kg/m2 and a body weight of 50 kg or higher. 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. Participants are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study. Exclusion Criteria 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. Participants who have any history or suspicion of kidney stones. 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. Women who are pregnant or breastfeeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABP-671, Cohort 1-<br>ABP-671, Cohort 1 participants received 50 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo). | Drug: ABP-671<br>* Drug: ABP-671, single oral dose<br>Other: Placebo<br>* Other: Placebo, single oral dose<br>|
| Experimental: ABP-671, Cohort 2-<br>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<br>* Drug: ABP-671, single oral dose<br>Other: Placebo<br>* Other: Placebo, single oral dose<br>|
| Experimental: ABP-671, Cohort 3-<br>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<br>* Drug: ABP-671, single oral dose<br>Other: Placebo<br>* Other: Placebo, single oral dose<br>|
| Experimental: ABP-671, Cohort 4-<br>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<br>* Drug: ABP-671, single oral dose<br>Other: Placebo<br>* Other: Placebo, single oral dose<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gout, hyperuricemia