A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671
Primary Purpose
Hyperuricemia, Gout
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ABP-671
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperuricemia focused on measuring Gout, Hyperuricemia
Eligibility Criteria
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.
Sites / Locations
- Celerion
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment with ABP-671
Treatment with placebo
Arm Description
Three sequential dose escalation cohorts of ABP-671 administered orally for 10 days.
Three sequential dose escalation cohorts of ABP-671 matching placebo administered orally for 10 days.
Outcomes
Primary Outcome Measures
Incidence of Adverse Events (AEs)
Measured by the number of patients with AEs
Secondary Outcome Measures
Maximum observed plasma concentration of ABP-671 (Cmax)
Area under time-concentration curve (AUC)
Time of maximum observed plasma concentration of ABP-671 (Tmax)
Volume of distribution (Vd)
Half life of ABP-671 (t1/2)
The effect of ABP-671 versus placebo on the percent change from baseline in serum uric acid
The effect of ABP-671 versus placebo on change in urine uric acid excretion
Full Information
NCT ID
NCT04060173
First Posted
August 15, 2019
Last Updated
February 10, 2020
Sponsor
Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04060173
Brief Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
December 29, 2019 (Actual)
Study Completion Date
February 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperuricemia, Gout
Keywords
Gout, Hyperuricemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with ABP-671
Arm Type
Experimental
Arm Description
Three sequential dose escalation cohorts of ABP-671 administered orally for 10 days.
Arm Title
Treatment with placebo
Arm Type
Placebo Comparator
Arm Description
Three sequential dose escalation cohorts of ABP-671 matching placebo administered orally for 10 days.
Intervention Type
Drug
Intervention Name(s)
ABP-671
Intervention Description
ABP-671 is an investigational drug
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Incidence of Adverse Events (AEs)
Description
Measured by the number of patients with AEs
Time Frame
38 days
Secondary Outcome Measure Information:
Title
Maximum observed plasma concentration of ABP-671 (Cmax)
Time Frame
2 weeks
Title
Area under time-concentration curve (AUC)
Time Frame
2 weeks
Title
Time of maximum observed plasma concentration of ABP-671 (Tmax)
Time Frame
2 weeks
Title
Volume of distribution (Vd)
Time Frame
2 weeks
Title
Half life of ABP-671 (t1/2)
Time Frame
2 weeks
Title
The effect of ABP-671 versus placebo on the percent change from baseline in serum uric acid
Time Frame
24 days
Title
The effect of ABP-671 versus placebo on change in urine uric acid excretion
Time Frame
24 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Armas, MD
Organizational Affiliation
Celerion
Official's Role
Principal Investigator
Facility Information:
Facility Name
Celerion
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671
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