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

A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Doses Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral ABP-745 Administration in Healthy Volunteers

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.

Study Overview

• Status: Recruiting
• Conditions: Gout
• Intervention / Treatment: Drug: Placebo; Drug: ABP-745

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ullrich Schwertschlag, MD, PhD; Phone Number: 1-978-257-1926; Email: ullrich.schwertschlag@atombp.com

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78217
      • Recruiting
      • Worldwide Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo tablet
Active Comparator: ABP-745	Drug: ABP-745; 0.5, 5 or 25 mg tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment-emergent adverse events (Safety and Tolerability)	Up to Day 14

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2024
• Primary Completion (Estimated): November 22, 2024
• Study Completion (Estimated): November 22, 2024

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: tophi, gout flares, gout chronic pain
• Other Study ID Numbers: ABP-745-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No