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

ConditionHealthy Vollunteer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorPyrotech Therapeutics, Inc.

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: PTT-121 treatmentExperimental treatment 1 intervention
Group B: Placebo treatmentPlacebo comparator 1 intervention

Trial outcomes

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

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pyrotech Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: