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

Phase 1

Completed

• Conditions: Gout; Hyperuricemia
• Interventions: Drug: ABP-671; Other: Placebo

• Registration Number: NCT03906006
• Lead Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Brief 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.

Study Timeline

• Study Start: 2018-10-17
• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-04-04
• Study First Posted: 2019-04-08
• Primary Completion: 2019-06-20
• Study Completion: 2019-06-20
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABP-671, Cohort 1-	ABP-671	ABP-671, Cohort 1 participants received 50 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).
ABP-671, Cohort 1-	Placebo	ABP-671, Cohort 1 participants received 50 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).
ABP-671, Cohort 2-	ABP-671	ABP-671, Cohort 2 participants will receive 0.1 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).
ABP-671, Cohort 2-	Placebo	ABP-671, Cohort 2 participants will receive 0.1 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).
ABP-671, Cohort 3-	ABP-671	ABP-671, Cohort 3 participants will receive 0.5 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).
ABP-671, Cohort 3-	Placebo	ABP-671, Cohort 3 participants will receive 0.5 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).
ABP-671, Cohort 4-	ABP-671	ABP-671, Cohort 4 participants will receive 1.0 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).
ABP-671, Cohort 4-	Placebo	ABP-671, Cohort 4 participants will receive 1.0 mg ABP-671 single agent or placebo during dose escalation (6 active: 2 placebo).

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	baseline to 7 days	Incidence of adverse events
Maximum tolerable dose	baseline to 7 days	Maximum tolerable dose

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Celerion; 🇺🇸 Tempe, Arizona, United States