COMPLETED

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

Conditions

Gout Acute Gout Flare Gout Flares tophi chronic pain

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-23

Study Completion:2024-07-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06258213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Study Locations (Sites)

Worldwide Clinical Trials

San Antonio, Texas, 78217

United States

Collaborators and Investigators

Sponsor: Atom Therapeutics Co., Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-23

Study Completion Date2024-07-29

Study Record Updates

Study Start Date2024-01-23

Study Completion Date2024-07-29

Terms related to this study

Keywords Provided by Researchers

acute gout flare
gout flares
tophi
chronic pain

Additional Relevant MeSH Terms

Gout
Acute Gout Flare
Gout Flares