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CompletedPhase 1

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

Key facts

Who runs it
Atom Therapeutics Co., Ltd
Where
San Antonio, United StatesSee the site
Trial code
Status
Completed
Phase
Phase 1
People taking part
90 people enrolled
Started
23 Jan 2024
Ended
29 Jul 2024
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • ABP-745
  • Placebo
Record updated
17 August 2025

Who can take part

Age
18 years to 55 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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
  • 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))
  • 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
  • Difficulties in venous blood collection or history of dizziness when encountering blood or needles
  • 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)
  • A known history of drug abuse within 2 years before the screening; or positive drug abuse test at screening
  • 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 in United States

  • Worldwide Clinical TrialsSan Antonio, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • PlaceboPlacebo, for comparison
  • ABP-745Existing treatment, for comparison

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Record updated
17 August 2025