NCT06200597

A Single and Multiple Ascending Dose Study of LAD603 in Healthy Subjects

A Phase 1 Randomized, 2-part, Single-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of LAD603 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Almirall, S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple ascending doses of LAD603 in healthy adult participants in both Part 1 and 2.

Detailed description

This is a 2-part study. Part 1 will comprise up to 8 cohorts of healthy adult participants and investigate single ascending doses of LAD603. Part 2 will comprise up to 4 cohorts of healthy adult subjects and will investigate multiple ascending doses of LAD603. Each ascending dose level will be investigated by a sequential cohort, with dose escalation based on satisfactory safety, tolerability, PK, and pharmacodynamics (PD) (biomarker) data from the previous cohort(s). Dose levels evaluated in Part 2 of this study will not exceed dose levels that were safe and well tolerated in the single-dose study, and may be changed, depending on emerging safety and tolerability, PK, and PD (biomarker) data. Each participant will participate for about 8 weeks in Part 1 and for about 14 weeks in Part 2 of the study.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	LAD603	LAD603 SC injection.
OTHER	Placebo	Matching placebo SC injection.

Timeline

• Start date: 2023-12-05
• Primary completion: 2025-05-11
• Completion: 2025-05-29
• First posted: 2024-01-11
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study