LAPIX Therapeutics Inc.
The goal of this clinical trial is to study the drug LPX-TI641 in patients with atopic dermatitis and psoriasis. We will compare the safety and tolerability of LPX-TI641 to placebo ( a look-alike solution) that contains no drug. We will also evaluate the plasma pharmacokinetics of LPX-TI641. LPX-TI641 (or placebo) will be administered orally for 28 days.
This is a Phase 1b, multi-center, randomized, double-blind, parallel-group, placebo-controlled multiple dose study in participants with atopic dermatitis or psoriasis. There will be 2 cohorts, one for each indication. Each cohort will consist of \~ 16-24participants (Total \~up to 48 participants). The Primary objective of the study is to evaluate the safety and tolerability after multiple oral doses of LPX-TI641 in participants with AD and PsO. And the secondary objective of the study is to evaluate the plasma pharmacokinetics after multiple oral doses of LPX-TI641 in participants with AD…
Inclusion Criteria: 1. Subject has signed an Informed Consent Form (ICF) prior to any study-specific procedures being performed 2. ≥ 18 years old, irrespective of their race and ethnicity. 3. Body Mass Index (BMI) 18.0-40.0 kg/m2, inclusive, at screening. 4. Participants are willing and able to adhere to study protocol requirements and restrictions including but not limited to scheduled outpatient visits, inpatient stay, laboratory tests, and 12-lead ECGs. 5. The subject must be judged to be in good health by the investigator to participate in the study, based on clinical evaluations, includi…
Oral administration QD for 28 consecutive days
Placebo an identical oral formulation without the LPX-TI641.
Arctuva estimate
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