NCT06488209

Single and Multiple Ascending Dose Study in Healthy Participants and Participants With an Autoimmune Disease

A Phase 1 Randomized, 3-Part, Placebo-Controlled, Single Ascending and Multiple Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of LAD191 in Healthy Subjects and Subjects With an Autoimmune Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Almirall, S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity of LAD191 in healthy adults and in adults with an autoimmune disease.

Detailed description

This is a 3-part study. Part 1 will be comprised of up to 5 cohorts of healthy adult participants and will investigate single ascending doses of LAD191. Part 2 will be comprised of up to 3 cohorts of healthy adult participants and will investigate multiple ascending doses of LAD191. Part 3 will be comprised of single cohort of participants with an autoimmune disease and will investigate repeat doses of LAD191. Each ascending dose level will be investigated by a sequential cohort, with dose escalation based on satisfactory safety, tolerability, PK, PD, immunogenicity, biomarker and clinical response assessments will be performed throughout. Each cohort will be randomized to receive LAD191 and placebo. Each participant will participate for about 14 weeks in Part 1, 17 weeks in Part 2 and 18 weeks in Part 3 of the study.

Conditions

• Healthy Volunteers
• Autoimmune Disease

Interventions

Type	Name	Description
DRUG	LAD191	LAD191 SC injection.
OTHER	Placebo	Matching placebo SC injection.

Timeline

• Start date: 2022-07-29
• Primary completion: 2025-04-03
• Completion: 2025-04-03
• First posted: 2024-07-05
• Last updated: 2025-11-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study