Safety and Pharmacokinetics of LPX-TI641 in Atopic Dermatitis and Psoriasis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorLAPIX Therapeutics Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject has signed an Informed Consent Form (ICF) prior to any study-specific procedures being performed
≥ 18 years old, irrespective of their race and ethnicity.
Body Mass Index (BMI) 18.0-40.0 kg/m2, inclusive, at screening.
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.
Disqualifiers
History of clinically significant medical conditions or any other reason that in the opinion of the PI would interfere with subject's participation in this study
History of clinically significant drug or alcohol abuse per the PI's opinion within the last 6 months.
Pregnant or lactating women or women currently undergoing infertility treatments or women who intend to become pregnant during the time of study or for 6 weeks after last dose.
Presence of skin comorbidities that would interfere with study assessment or response to treatment
Trial design
Design model
Parallel
Treatments tested in this trial
LPX-TI641
DrugOral administration QD for 28 consecutive days
Placebo
DrugPlacebo an identical oral formulation without the LPX-TI641.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: PsoriasisExperimental treatment 2 interventions
Group B: Atopic dermatitisExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
To evaluate the safety and tolerability after multiple oral doses of LPX-TI641 in participants with PsO and AD.
Rate and severity of treatment-emergent adverse events, including serious adverse events.
Time frame
84 daysSecondary outcomes
1
To evaluate the plasma pharmacokinetics after multiple oral doses of LPX TI641 in participants with PsO and AD.
Measure Area Under the Concentration Time Curve after single dose and at Steady State
Time frame
24 hours on Day 1 and 24 hours on Day 28Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov