Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
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 rheumatoid arthritis and psoriatic arthritis. We will compare the safety and tolerability of LPX-TI641 to placebo 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) 18.0-35.0 kg/m2, inclusive, at screening.
Participants are willing and able to adhere to study protocol requirements including but not limited to scheduled outpatient visits, inpatient hospital 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 per the PI's opinion drug or alcohol abuse 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 enrollment.
Any known history of malignancy within 5 years other than other than completely treated non-metastatic basal cell carcinomas or squamous cell carcinomas of the skin or localized carcinoma in situ of the cervix.
Trial design
Design model
Parallel
Treatments tested in this trial
LPX-TI641
DrugOral administration QD for 28 consecutive days
Placebo
DrugDrug is LPX-TI641. Placebo an identical formulation without the LPX-TI641.
Treatment groups
48 Participants
are divided into 2 treatment groupsGroup A: Rheumatoid arthritisExperimental treatment 2 interventions
Group B: Psoriatic ArthritisExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
To evaluate the safety and tolerability after multiple oral doses of LPX-TI641 in participants with RA and PsA.
Rate and severity of treatment-emergent adverse events, including serious adverse events.
Time frame
56 daysSecondary outcomes
1
To evaluate the plasma pharmacokinetics after multiple oral doses of LPX TI641 in participants with RA and PsA.
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 282
To evaluate the plasma pharmacokinetics after multiple oral doses of LPX TI641 in participants with RA and PsA
Measure maximum plasma concentration (Cmax) 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