HyperuricemiaPhase 1NCT04060173
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671
A Phase 1 study testing ABP-671 in people with Hyperuricemia and Gout, run by Atom Therapeutics Co., Ltd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperuricemia, Gout
- What is being tested?
- ABP-671
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2019to 7 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Hyperuricemia, Gout
- Being tested
- ABP-671, Placebo
- Keywords
- Gout, Hyperuricemia
- Medical subject headings
- Hyperuricemia, Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABP-671Drug
ABP-671 is an investigational drug
PlaceboOther
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment with ABP-671 | Experimental | Three sequential dose escalation cohorts of ABP-671 administered orally for 10 days. Receives: Drug: ABP-671 |
| Treatment with placebo | Placebo comparator | Three sequential dose escalation cohorts of ABP-671 matching placebo administered orally for 10 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Measured by the number of patients with AEs
Measured: 38 days
Secondary outcomes (7)
Maximum observed plasma concentration of ABP-671 (Cmax)
Measured: 2 weeks
Area under time-concentration curve (AUC)
Measured: 2 weeks
Time of maximum observed plasma concentration of ABP-671 (Tmax)
Measured: 2 weeks
Volume of distribution (Vd)
Measured: 2 weeks
Half life of ABP-671 (t1/2)
Measured: 2 weeks
The effect of ABP-671 versus placebo on the percent change from baseline in serum uric acid
Measured: 24 days
The effect of ABP-671 versus placebo on change in urine uric acid excretion
Measured: 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start5 Sep 2019
- Primary completion29 Dec 2019
- Study completion7 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperuricemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atom Therapeutics Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Danielle Armas, MD, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060173
- Sponsor's protocol ID
- ABP-671-102
- Status last verified
- Feb 2020
- First submitted
- 15 Aug 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04060173
- Acronym / sponsor ID
- ABP-671-102
- Conditions
- Hyperuricemia, Gout
- Keywords
- Gout, Hyperuricemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Atom Therapeutics Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 29 Dec 2019 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with ABP-671 | Experimental | Drug: ABP-671Three sequential dose escalation cohorts of ABP-671 administered orally for 10 days. |
| Treatment with placebo | Placebo comparator | Other: PlaceboThree sequential dose escalation cohorts of ABP-671 matching placebo administered orally for 10 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABP-671ABP-671 is an investigational drug | Drug | Treatment with ABP-671 |
| PlaceboMatching placebo | Other | Treatment with placebo |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: 38 days
Measured by the number of patients with AEs
7 secondary outcomes
Maximum observed plasma concentration of ABP-671 (Cmax)
Time frame: 2 weeks
Area under time-concentration curve (AUC)
Time frame: 2 weeks
Time of maximum observed plasma concentration of ABP-671 (Tmax)
Time frame: 2 weeks
Volume of distribution (Vd)
Time frame: 2 weeks
Half life of ABP-671 (t1/2)
Time frame: 2 weeks
The effect of ABP-671 versus placebo on the percent change from baseline in serum uric acid
Time frame: 24 days
The effect of ABP-671 versus placebo on change in urine uric acid excretion
Time frame: 24 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Armas, MD principal investigator
Celerion
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABP-671 in people with Hyperuricemia and Gout, run by Atom Therapeutics Co., Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) (time frame: 38 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.