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
Overview
- Phase
- Phase 1
- Intervention
- ABP-671
- Conditions
- Gout
- Sponsor
- Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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).
Intervention: ABP-671
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).
Intervention: Placebo
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).
Intervention: ABP-671
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).
Intervention: Placebo
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).
Intervention: ABP-671
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).
Intervention: Placebo
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).
Intervention: ABP-671
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).
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence of adverse events
Time Frame: baseline to 7 days
Incidence of adverse events
Maximum tolerable dose
Time Frame: baseline to 7 days
Maximum tolerable dose
Secondary Outcomes
- Peak plasma concentration(baseline to 72 hours)
- half-life(baseline to 72 hours)
- area under the curve(baseline to 72 hours)
- volume of distribution(baseline to 72 hours)
- level of serum and urine uric acid(baseline to 72 hours)
- level of serum and urine creatinine(baseline to 72 hours)