Status:
COMPLETED
D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers
Lead Sponsor:
InventisBio Co., Ltd
Conditions:
Gout
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This initial clinical study in the US will be a randomized, double-blind, placebo-controlled, single-dose, dose-escalation, and sequential cohort study to evaluate the safety, tolerability, PK and PD ...
Eligibility Criteria
Inclusion
- Subjects must be medically documented as healthy and acceptable at physical examination.
- Subjects serum uric acid level at screening ≥ 4.5 mg/dL.
- Subjects must have a BMI between 18.0 and 30.0 kg/m2 and a body weight of 50 kg or higher
- Subjects must have all laboratory parameters within the normal range or considered not clinically significant by the principal investigator.
- Subjects must have a normal urinalysis, eGFR, ECG or results considered not clinically significant by the principal investigator.
- Subjects are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study.
Exclusion
- Any history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
- Any history or suspicion of kidney stones.
- Positive for HIV, Hepatitis B, and/or Hepatitis C.
- Subjects who have used prescription drugs, over-the-counter drugs, or herbal remedies within 14 days before Day 1 of study medication dosing.
- Undergone major surgery within 3 months prior to Day 1.
- Women who are pregnant or breastfeeding.
- Subjects who received any investigational test article within 5 half-lives or 30 days prior to Day 1 study medication dosing.
- Subjects who consumed Seville oranges- or grapefruit-containing foods or beverages within 7 days before Day 1 and during the entire study duration.
- Subjects with any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study.
Key Trial Info
Start Date :
September 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2018
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03291782
Start Date
September 13 2017
End Date
August 6 2018
Last Update
December 19 2018
Active Locations (1)
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1
Covance Daytona Beach Clinical Research Unit
Daytona Beach, Florida, United States, 32117