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

NCT ID: NCT03906006

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-17
• Study Completion Date: 2019-06-20

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.

Conditions

Gout; Hyperuricemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

ABP-671

Intervention Type: DRUG

Drug: ABP-671, single oral dose

Placebo

Intervention Type: OTHER

Other: Placebo, single oral dose

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).

Group Type: EXPERIMENTAL

ABP-671

Intervention Type: DRUG

Drug: ABP-671, single oral dose

Placebo

Intervention Type: OTHER

Other: Placebo, single oral dose

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).

Group Type: EXPERIMENTAL

ABP-671

Intervention Type: DRUG

Drug: ABP-671, single oral dose

Placebo

Intervention Type: OTHER

Other: Placebo, single oral dose

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).

Group Type: EXPERIMENTAL

ABP-671

Intervention Type: DRUG

Drug: ABP-671, single oral dose

Placebo

Intervention Type: OTHER

Other: Placebo, single oral dose

Interventions

ABP-671

Drug: ABP-671, single oral dose

Intervention Type: DRUG

Placebo

Other: Placebo, single oral dose

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atom Therapeutics Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danielle Armas, M.D.

Role: PRINCIPAL_INVESTIGATOR

Celerion

Locations

Celerion

Tempe, Arizona, United States

Countries

United States

Other Identifiers

ABP-671-101

Identifier Type: -

Identifier Source: org_study_id