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CompletedNCT06258213ABP-745Updated Aug 17, 2025

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral ABP-745 Administration in Healthy Volunteers

A Phase 1 interventional study of ABP-745 and Placebo in Gout, Acute Gout Flare and Gout Flares, sponsored by Atom Therapeutics Co., Ltd. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-17.

Sponsored by Atom Therapeutics Co., Ltd · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Jul 2024, 2 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

A randomized, double-blind, placebo-controlled, dose-escalation study will be conducted in healthy volunteers. This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ABP-745 following single (Part 1) and multiple (Part 2) oral doses.

02

Conditions studied

  • Gout
  • Acute Gout Flare
  • Gout Flares

Keywords

  • acute gout flare
  • gout flares
  • tophi
  • chronic pain
03

In context

Gout

232 studies on the registry are indexed under Gout; 45 are open to participants now.

This study's enrollment of 90 is below the median of 121 across 202 interventional studies indexed under Gout.

Browse Gout studies →

Lead sponsor

Atom Therapeutics Co., Ltd is the lead sponsor of 7 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy male or female volunteers, aged 18 and 55 years (inclusive) at the time of signing the informed consent form (ICF).
  • Body mass index (BMI) range within 18 \~ 30 kg/m2 (inclusive), and body weight of ≥ 50.0 kg for male and ≥ 45.0 kg for female.
  • Generally healthy based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests.
  • Female volunteers of child-bearing potential must agree to use effective contraceptive methods from the screening period to 90 days after the last dose of the investigational product (IP).

Exclusion criteria

Exclusion Criteria:

  • Difficulties in venous blood collection or history of dizziness when encountering blood or needles.
  • Has received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month or 5 times half-life (whichever is longer) prior to the first dose of IP.
  • Has a history of gastrointestinal (such as duodenal ulcer, alimentary tract hemorrhage, gastro esophageal reflux disease (GERD), etc.), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs as determined by the Investigator (or Sub-investigator).
  • Has the medical history (including past and present) of other significant diseases (including but not limited to pulmonary, cardiovascular, gastrointestinal, hematological, endocrinological and metabolic disease, immunological, dermatological, malignant diseases, mental and nervous systems, and other related diseases) or any other disease/ailment at the discretion of the Investigator (or Sub-investigator).
  • Any medication (prescription and nonprescription) within 14 days or 5 times the half-life (whichever is longer) prior to the first dose of IP. (Excluding oral contraceptives, or topical ointments at the discretion of the Investigator (or Sub-investigator)).
  • A known history of drug abuse within 2 years before the screening; or positive drug abuse test at screening.
  • Blood donation or blood loss of more than 400 mL within 3 months before the screening.
  • Smoking history (≥ 5 cigarettes per day) within 3 months before the screening, or cannot abstain from any tobacco products during the study.
  • Positive screening test for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Active comparator
    ABP-745

    Drug: ABP-745

Interventions

  • DrugABP-745

    0.5, 5 or 25 mg tablet

  • DrugPlacebo

    Placebo tablet

06

What researchers measure

Primary outcomes

  1. Incidence of treatment-emergent adverse events (Safety and Tolerability)

    Time frame: Up to Day 14

Secondary outcomes

  1. Plasma pharmacokinetic parameters including peak plasma concentration (Cmax)

    Time frame: Up to Day 11

  2. Urine pharmacokinetic parameters including amount excreted in urine over the sampling interval (Ae)

    Time frame: Up to Day 8

07

Study locations

1 site
  • Worldwide Clinical Trials
    San Antonio, Texas 78217, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06258213
Lead sponsor
Atom Therapeutics Co., Ltd
Responsible party
Sponsor
First posted
Feb 14, 2024
Start date
Jan 23, 2024
Primary completion
Jul 29, 2024
Completion
Jul 29, 2024
Last update
Aug 17, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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