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Clinical Trials in China / NCT07768176
Recruiting Phase 1

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PTT-121

NCT07768176 · tracked via the Priya Life Science China tracker
Sponsor
Pyrotech Therapeutics, Inc
Phase
Phase 1
Started
2026-08-18
Last updated
2026-10-27

Condition(s) studied

Healthy Vollunteer

Investigational drug(s) / intervention(s)

PTT-121PTT-121 placebo

PTT-121: PTT-121 will be administered intravenously

PTT-121 placebo: Matching placebo identical to PTT-121 formulation but without the active pharmaceutical ingredient

Study 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

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Number of Participants With Treatment-emergent Adverse Events — SAD: up to 15 days MAD: up to 21 days

Trial sites (1)

FacilityCityRegionStatus
Peking University Third Hospital Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07768176 on ClinicalTrials.gov ↗ ← All trials in China