Safety Evaluation of Escalating Doses
Conditions
Brief summary
This Phase 1, double-blind (sponsor open), placebo controlled study will assess the safety, tolerability and pharmacokinetics of multiple doses of LW402 tablets in healthy volunteers.
Interventions
DRUGExperimental
LW402 Tablets
DRUGPlacebo
LW402 Placebo Tablets
Sponsors
Shanghai Longwood Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female subjects of non-child bearing potential as determined by medical history, physical exam and vial sign measurements * Body Mass Index of 18-26 kg/m2 inclusive with body weight males ≥ 50 kg, females ≥ 45 kg
Exclusion criteria
* Clinically significant disease that requires a physician's care and/or would interfere with study evaluations * History of drug or alcohol abuse, consumption of alcohol within 48 hours prior to randomization, or a positive test for alcohol or drugs with a high potential for abuse prior to randomization * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability Assessment | up to 9 days | Safety and Tolerability Assessment: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), along with abnormal clinical laboratory parameters, vital signs, physical examination findings, and 12-lead electrocardiogram (ECG) results. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the PK characteristics | up to 9 days | Measuring the level of LW402 and its primary metabolite in the blood. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORWei Zhao
Shandong First Medical University
Outcome results
None listed