- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04060173
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671
February 10, 2020 updated by: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
A Randomized, Double-Blind, Placebo-Controlled Phase 1b Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 Administered Orally for 10 Days in Subjects With Hyperuricemia
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of ABP-671 administered orally in subjects with hyperuricemia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
27
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85283
- Celerion
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects must be medically documented as healthy and acceptable at screening.
- Subjects must have serum uric acid level at screening ≥ 7.0 mg/dL for men, ≥ 6.0 mg/dL for women.
- Subjects must have a Body Mass Index (BMI) between 18.0 and 34.0 kg/m2 (inclusive).
- Subjects must have a body weight of 50 kg or higher.
- The subject agrees to abstain from alcohol consumption for 48 hours prior to dosing, for the duration of the in-house study period, and for 48 hours prior to each in-clinic follow up visit.
- The subject is a nonsmoker.
- Women must be non-pregnant and non-lactating, and either surgically sterile or postmenopausal for ≥ 12 months.
- Men must be surgically sterile, abstinent or if engaged in sexual relations with a female partner of child-bearing potential, the participant must be using a condom with spermicide from Screening and for a period of 30 days after the last dose of Study Drug. The Investigator will assess the adequacy of methods of contraception on a case-by-case basis.
- Subjects must have a complete blood count (CBC) and platelet count within the normal range or considered not clinically significant by the principal investigator.
- Other than elevated serum uric acid, subjects must have normal blood chemistry or results considered not clinically significant by the investigator.
- Subjects must have a normal urinalysis or results considered not clinically significant by the investigator including a normal protein/creatinine ratio per local lab reference ranges (≤ 200 mg/g) and a urine creatinine result that does not exceed 300 mg/dL. Any out of range values may be repeated per Investigator discretion.
- Subjects must have a normal ECG or results considered not clinically significant by the principal investigator.
- Subjects must be able to comply with the study and follow-up procedures.
- Subjects are able to understand the study procedures and risks involved and must provide signed informed consent to participate in the study.
Exclusion Criteria:
- Subjects with any history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders.
- Subjects who are positive for human immunodeficiency virus (HIV), Hepatitis B surface antigen, and/or Hepatitis C virus.
- Subjects who have used prescription drugs, over-the-counter drugs, or herbal remedies within 3 weeks before Day 1 of study medication dosing.
- Subjects who are positive for urine drug and alcohol screening tests.
- Subjects who have 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, whichever is longer, prior to Day 1 study medication dosing.
- Recent blood donation for more than 500 mL within 2 months of screening.
- Abnormal ECG including QTc > 470 (F) and > 450 (M).
- 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.
- Prior exposure to ABP-671.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment with ABP-671
Three sequential dose escalation cohorts of ABP-671 administered orally for 10 days.
|
ABP-671 is an investigational drug
|
PLACEBO_COMPARATOR: Treatment with placebo
Three sequential dose escalation cohorts of ABP-671 matching placebo administered orally for 10 days.
|
Matching placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Adverse Events (AEs)
Time Frame: 38 days
|
Measured by the number of patients with AEs
|
38 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum observed plasma concentration of ABP-671 (Cmax)
Time Frame: 2 weeks
|
2 weeks
|
Area under time-concentration curve (AUC)
Time Frame: 2 weeks
|
2 weeks
|
Time of maximum observed plasma concentration of ABP-671 (Tmax)
Time Frame: 2 weeks
|
2 weeks
|
Volume of distribution (Vd)
Time Frame: 2 weeks
|
2 weeks
|
Half life of ABP-671 (t1/2)
Time Frame: 2 weeks
|
2 weeks
|
The effect of ABP-671 versus placebo on the percent change from baseline in serum uric acid
Time Frame: 24 days
|
24 days
|
The effect of ABP-671 versus placebo on change in urine uric acid excretion
Time Frame: 24 days
|
24 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 5, 2019
Primary Completion (ACTUAL)
December 29, 2019
Study Completion (ACTUAL)
February 7, 2020
Study Registration Dates
First Submitted
August 15, 2019
First Submitted That Met QC Criteria
August 15, 2019
First Posted (ACTUAL)
August 19, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 12, 2020
Last Update Submitted That Met QC Criteria
February 10, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABP-671-102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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