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NCT07768176
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PTT-121
Conditions: Healthy Vollunteer
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 84
Sponsor: Pyrotech Therapeutics, Inc.
Location: Peking University Third Hospital Beijing Beijing Municipality
Summary
This is a Phase I, single-center, randomized, double-blind, placebo-controlled SAD/MAD study to evaluate safety, tolerability, and PK of Intravenously Administered PTT-121 in healthy Chinese adults.
Eligibility Criteria
Inclusion Criteria:
* Healthy adults aged between 18 and 55 years.
* BMI 18.0-26.0.
* Those who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination, etc.
Exclusion Criteria:
* History of any clinically significant disease or disorder of the cardiovascular, respiratory, gastrointestinal, genitourinary, hematologic/lymphatic, neurologic, reproductive, psychiatric, endocrine, immunologic, musculoskeletal, breast, ear, ocular, thyroid, neoplastic, metabolic, or dermatologic systems, as determined by the Investigator.
* History of hypersensitivity to the active ingredient of the investigational product, any of its excipients, or related compounds; or a history of severe drug-induced allergic reactions, including but not limited to angioedema and bronchospasm/asthma.
Source: ClinicalTrials.gov (NCT07768176). StuddyBuddy aggregates publicly available trial information.