A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Food Effect of THB001 in Healthy Subjects

Third Harmonic Bio.0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

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•Subjects must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-related procedures.
•Healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG recording.
•Men and women aged 18-65 years (inclusive) who meet all entry criteria.

•A history or presence of cancer or of a clinically significant hepatic, biliary, renal, gastrointestinal, cardiovascular, endocrine, pulmonary, ophthalmologic, immunologic, hematologic, dermatologic, or neurologic abnormality.
•Evidence or history of anemia, thrombocytopenia, or leukopenia.
•Use of any prescription or non-prescription drugs (excluding paracetamol), antacids, vitamins, herbal, and dietary supplements (including St John’s Wort) within 14 days (or 28 days if the drug is a potential hepatic enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
•A positive pregnancy test (at Screening or on Day -1 of the (first) treatment period) or lactation.
•A history or presence of any disease, condition, or surgery likely to affect drug absorption, distribution, metabolism, or excretion.
•A clinically significant abnormality on physical examination, neurological examination, ECG, or laboratory evaluations at Screening or between Screening and (first) dose administration.

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