Healthy Vollunteer
Conditions
Brief 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.
Interventions
DRUGPTT-121
PTT-121 will be administered intravenously
DRUGPTT-121 placebo
Matching placebo identical to PTT-121 formulation but without the active pharmaceutical ingredient
Sponsors
Pyrotech Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events | SAD: up to 15 days MAD: up to 21 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of PTT-121 | 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. |
Countries
China
Contacts
CONTACTRan Wei
Outcome results
None listed