NCT07471932

A Study of LAD106 in Healthy Adult Participants

A Phase 1, Randomized, Two-part, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity and Pharmacodynamics of LAD106 in Healthy Adult Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 93 (estimated)
• Sponsor: Almirall, S.A. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The main aim of this study is to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD) of single ascending doses of LAD106 (Part A) and multiple ascending doses of LAD106 (Part B) in human healthy participants.

Detailed description

This is a 2-part study. Part A will comprise up to 6 cohorts of healthy adult participants and investigate single ascending doses of LAD106. Part B will comprise up to 3 cohorts of healthy adult participants to evaluate multiple ascending doses of LAD106, and 1 cohort will investigate the pharmacodynamic effects of lebrikizumab. The study is based on sequential cohorts for escalation of single and multiple doses of LAD106, where progression to the next cohort is only started following a review of safety, tolerability, and pharmacokinetic data of earlier study cohorts.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	LAD106	LAD106 will be administered.
DRUG	Lebrikizumab	Lebrikizumab will be administered.
OTHER	Placebo	Placebo matching LAD106 will be administered.

Timeline

• Start date: 2026-02-17
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: Netherlands