Phase
Condition
Arthritis And Arthritic Pain (Pediatric)
Collagen Vascular Diseases
Joint Injuries
Treatment
Placebo
ABP-745
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
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-lead ECG, and clinical laboratory tests.
Female volunteers of child-bearing potential must agree to use effectivecontraceptive methods from the screening period to 90 days after the last dose ofthe investigational 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 productor medication) within 1 month or 5 times half-life (whichever is longer) prior tothe first 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 (orSub-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 relateddiseases) or any other disease/ailment at the discretion of the Investigator (orSub-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 thescreening.
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
Connect with a study center
Worldwide Clinical Trials
San Antonio, Texas 78217
United StatesSite Not Available

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