RecruitingAtopic Dermatitis (AD)Psoriasis (PsO)
Safety and Pharmacokinetics of LPX-TI641 in Atopic Dermatitis and Psoriasis
Eligible age
18+ yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: LAPIX Therapeutics Inc.
You may qualify if…
- ✓ 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, including laboratory safety tests, medical history, physical examination, vital signs and 12-lead ECG completed at the screening visit and prior to the first dose of study drug.
- ✓ 6. Female subject is postmenopausal (at least 1 year; to be confirmed by FSH if less than 2 years since last menstrual period), permanently sterilized (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy) or if of childbearing potential and engaged in sexual activity that can result in pregnancy must agree to use any two of the highly effective contraception methods listed below. Male participants with a partner of childbearing potential must also agree to use any two of the highly effective contraception methods listed below between them and their partner. This criterion must be followed from screening visit to 6 weeks after the last dose in females and for 90 days after the last dose for males.
- ✓ The following applies to all female participants with childbearing potential and female partners of male participants enrolled in the study.
- ✓ 1. Implantable progestogen-only hormone contraception associated with inhibition of ovulation.
You may not qualify if…
- ✕ 1. 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
- ✕ 2. History of clinically significant drug or alcohol abuse per the PI's opinion within the last 6 months.
- ✕ 3. 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.
- ✕ 4. Presence of skin comorbidities that would interfere with study assessment or response to treatment
- ✕ 5. Any known history of malignancy within 5 years other than completely treated non-metastatic basal cell carcinomas or squamous cell carcinomas of the skin or localized carcinoma in situ of the cervix.
- ✕ 6. Patients who are currently experiencing a skin infection that requires treatment, or is currently being treated, with topical or systemic antibiotics
- ✕ 7. Symptomatic herpes zoster within 3 months of screening
- ✕ 8. For the plaque psoriasis cohort,
Where it's recruiting
North Dakota
Fargo
Texas
Dallas
Source: ClinicalTrials.gov · NCT06982352 · last updated 2025-12-19