Gout, Hyperuricemia
Conditions
Keywords
gout, hyperuricemia
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.
Interventions
DRUGABP-671
Drug: ABP-671, single oral dose
OTHERPlacebo
Other: Placebo, single oral dose
Sponsors
Atom Therapeutics Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | baseline to 7 days | Incidence of adverse events |
| Maximum tolerable dose | baseline to 7 days | Maximum tolerable dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| area under the curve | baseline to 72 hours | area under the curve |
| volume of distribution | baseline to 72 hours | volume of distribution |
| Peak plasma concentration | baseline to 72 hours | Peak plasma concentration |
| level of serum and urine creatinine | baseline to 72 hours | level of serum and urine creatinine |
| level of serum and urine uric acid | baseline to 72 hours | level of serum and urine uric acid |
| half-life | baseline to 72 hours | half-life |
Countries
United States
Outcome results
None listed