NCT03906006

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Atom Therapeutics Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Gout
• Hyperuricemia

Interventions

Type	Name	Description
DRUG	ABP-671	Drug: ABP-671, single oral dose
OTHER	Placebo	Other: Placebo, single oral dose

Timeline

• Start date: 2018-10-17
• Primary completion: 2019-06-20
• Completion: 2019-06-20
• First posted: 2019-04-08
• Last updated: 2020-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study