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

Gout Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03906006
• Other study ID #: ABP-671-101
• Status: Completed
• Phase: Phase 1
• Start date: October 17, 2018
• Est. completion date: June 20, 2019

Study information

• Verified date: July 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 single ascending doses of ABP-671 administered orally in healthy volunteers.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 20, 2019
• Est. primary completion date: June 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gout
• Hyperuricemia

Intervention

Drug:
• ABP-671
Drug: ABP-671, single oral dose

Other:
• Placebo
Other: Placebo, single oral dose

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	Incidence of adverse events	baseline to 7 days
Primary	Maximum tolerable dose	Maximum tolerable dose	baseline to 7 days
Secondary	Peak plasma concentration	Peak plasma concentration	baseline to 72 hours
Secondary	half-life	half-life	baseline to 72 hours
Secondary	area under the curve	area under the curve	baseline to 72 hours
Secondary	volume of distribution	volume of distribution	baseline to 72 hours
Secondary	level of serum and urine uric acid	level of serum and urine uric acid	baseline to 72 hours
Secondary	level of serum and urine creatinine	level of serum and urine creatinine	baseline to 72 hours