Evaluating the safety and effects of ABP-745 in healthy volunteers
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
This study is testing a new drug called ABP-745 in healthy volunteers to see how safe it is and how the body processes it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT06258213 on ClinicalTrials.gov |
What this trial studies
This study is a randomized, double-blind, placebo-controlled, dose-escalation trial designed to assess the safety, tolerability, and pharmacokinetics of ABP-745 in healthy volunteers. Participants will receive either the investigational drug or a placebo in single and multiple doses. The study aims to gather data on how the drug is processed in the body and its overall safety profile.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male or female volunteers aged 18 to 55 with a BMI between 18 and 30.
Not a fit: Patients with a history of gastrointestinal issues or those who have recently received experimental treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for patients suffering from gout.
How similar studies have performed: While this study focuses on a novel investigational drug, similar studies evaluating pharmacokinetics and safety in healthy volunteers have shown success in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Antonio, Texas
- Worldwide Clinical Trials — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Ullrich Schwertschlag, MD, PhD
- Email: ullrich.schwertschlag@atombp.com
- Phone: 1-978-257-1926
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.