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NCT Number: NCT07768176

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

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.

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Key information

Conditions

Healthy Vollunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PTT-121

Drug

PTT-121 will be administered intravenously

PTT-121 placebo

Drug

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

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events

    Time frame: SAD: up to 15 days MAD: up to 21 days

Secondary outcomes

  1. Pharmacokinetics of PTT-121

    Time frame: SAD: up to 2 days MAD: up to 7 days

    The drug concentrations of PTT-121will be determined at multiple time points after drug administration.

Study contacts

Contact information is provided by the study sponsor or research team.

Ran Wei

CONTACT

[email protected]

+86 10 81938094

Sponsors and collaborators

Lead sponsor

Pyrotech Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered PTT-121 After Single and Multiple Ascending Doses in Healthy Chinese Subjects

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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