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

NCT06258213 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: ABP-745-101
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gout; Acute Gout Flare; Gout Flares

Keywords

acute gout flare; gout flares; tophi; chronic pain

Outcome Measures

Primary Outcomes (1)

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

  Up to Day 14

Secondary Outcomes (2)

• Plasma pharmacokinetic parameters including peak plasma concentration (Cmax)

  Up to Day 11

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

  Up to Day 8

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

ABP-745

ACTIVE COMPARATOR

Drug: ABP-745

Interventions

ABP-745 DRUG

0.5, 5 or 25 mg tablet

ABP-745

Placebo DRUG

Placebo tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atom Therapeutics Co., Ltd: lead

Study Sites (1)

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Conditions

Gout; Chronic Pain

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 14, 2024
• Study Start: January 23, 2024
• Primary Completion: July 29, 2024
• Study Completion: July 29, 2024
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)