NCT06982352

Safety and Pharmacokinetics of LPX-TI641 in Atopic Dermatitis and Psoriasis

Phase 1b Randomized, Double Blind, Placebo-controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of LPX-TI641 in Patients With Atopic Dermatitis and Psoriasis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: LAPIX Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 and PsO.

Conditions

• Atopic Dermatitis (AD)
• Psoriasis (PsO)

Interventions

Type	Name	Description
DRUG	LPX-TI641	Oral administration QD for 28 consecutive days
DRUG	Placebo	Placebo an identical oral formulation without the LPX-TI641.

Timeline

• Start date: 2025-06-15
• Primary completion: 2026-01-15
• Completion: 2026-04-15
• First posted: 2025-05-21
• Last updated: 2025-12-19

Locations

3 sites across 2 countries: United States, Jordan

Regulatory

• FDA-regulated drug study