A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral ABP-745 Administration… (NCT06258213) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral ABP-745 Administration in Healthy Volunteers
United States90 participantsStarted 2024-01-23
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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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, m…
What they're measuring
1
Incidence of treatment-emergent adverse events (Safety and Tolerability)