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

Last updated: February 5, 2024
Sponsor: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Bone Diseases

Joint Injuries

Arthritis And Arthritic Pain (Pediatric)

Treatment

Placebo

ABP-745

Clinical Study ID

NCT06258213
ABP-745-101
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy male or female volunteers, aged 18 and 55 years (inclusive) at the time ofsigning 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-leadECG, and clinical laboratory tests.
  • Female volunteers of child-bearing potential must agree to use effective contraceptivemethods from the screening period to 90 days after the last dose of theinvestigational product (IP).

Exclusion

Exclusion Criteria:

  • Difficulties in venous blood collection or history of dizziness when encounteringblood or needles.
  • Has received an experimental agent (vaccine, drug, biologic, device, blood product ormedication) within 1 month or 5 times half-life (whichever is longer) prior to thefirst dose of IP.
  • Has a history of gastrointestinal (such as duodenal ulcer, alimentary tracthemorrhage, 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 anyother disease/ailment at the discretion of the Investigator (or Sub-investigator).
  • Any medication (prescription and nonprescription) within 14 days or 5 times thehalf-life (whichever is longer) prior to the first dose of IP. (Excluding oralcontraceptives, or topical ointments at the discretion of the Investigator (orSub-investigator)).
  • A known history of drug abuse within 2 years before the screening; or positive drugabuse 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, orcannot abstain from any tobacco products during the study.
  • Positive screening test for human immunodeficiency virus (HIV) antibody, hepatitis Bsurface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV)antibody.

Study Design

Total Participants: 126
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
January 03, 2024
Estimated Completion Date:
November 22, 2024

Connect with a study center

  • Worldwide Clinical Trials

    San Antonio, Texas 78217
    United States

    Active - Recruiting

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