Phase 1b Randomized, Double Blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of LPX-TI641 in Patients With Atopic Dermatitis and Psoriasis
LAPIX Therapeutics Inc.
Summary
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugLPX-TI641
Oral administration QD for 28 consecutive days
- DrugPlacebo
Placebo an identical oral formulation without the LPX-TI641.
Locations (3)
- Red River Research PartnersFargo, North Dakota
- Clinical Investigations of TexasDallas, Texas
- Triumpharma Clinical Research Unit at AlEssra HospitalAmman, Jordan