Clinical trial NCT03906006: A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout
Hyperuricemia
Keywords: gout
hyperuricemia
Lead sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-04-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: baseline to 7 days
measure: Maximum tolerable dose
timeFrame: baseline to 7 days
Secondary outcomes:
measure: Peak plasma concentration
timeFrame: baseline to 72 hours
measure: half-life
timeFrame: baseline to 72 hours
measure: area under the curve
timeFrame: baseline to 72 hours
measure: volume of distribution
timeFrame: baseline to 72 hours
measure: level of serum and urine uric acid
timeFrame: baseline to 72 hours
measure: level of serum and urine creatinine
timeFrame: baseline to 72 hours
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion
state: Arizona
Study officials:
affiliation: Celerion
name: Danielle Armas, M.D.
role: PRINCIPAL_INVESTIGATOR
References: