NCT05331300

A Study to Evaluate the Safety, Preliminary Efficacy, and Pharmacokinetic Properties of LASN01 in Healthy Subjects and in Patients With Pulmonary Fibrosis or Thyroid Eye Disease

A Phase 1/2a, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Preliminary Efficacy, Immunogenicity and Pharmacokinetic Properties of LASN01 in Healthy Subjects and in Patients With Pulmonary Fibrosis or Thyroid Eye Disease

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Lassen Therapeutics 1 PTY LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

LASN01 is a novel, fully human antibody directed against the human IL-11 receptor that is being developed to address the fibro-inflammatory pathology of pulmonary fibrosis and TED. This study is a four-part trial consisting of Parts A, B, C and D. The primary objective of this study is to evaluate the safety and tolerability of LASN01, and the secondary objective is to evaluate the preliminary efficacy, immunogenicity, and pharmacokinetics of single and multiple doses of LASN01 in healthy participants and in patients with idiopathic pulmonary fibrosis (IPF) or progressive fibrosing interstitial lung disease (PF-ILD) or Thyroid Eye disease (TED). Please note that both the Phase 1 (single and multiple ascending dose, SAD/MAD) portion in healthy volunteers and the Phase 2a portion in patients are completed.

Detailed description

This randomized, placebo-controlled clinical trial (LASN01-CL-1101) consists of 4 parts, each part containing adaptive design elements that can be modified. In Phase 1, Part A comprised of a single-dose administration in healthy participants in 5 dose cohorts and Part B comprised of a multiple-dose administration in healthy participants in 2 dose cohorts. Parts A\&B have been completed. In the Phase 2a portion, Part C comprised of a multiple-dose administration in a single cohort of patients with IPF and PF-ILD, and Part D comprised of a multiple-dose design in a single cohort of patients with TED. In each part of the study, participants were randomized to receive IV doses of LASN01 or placebo.

Conditions

• Pulmonary Fibrosis
• Thyroid Eye Disease

Interventions

Type	Name	Description
DRUG	LASN01	Escalating single and multiple doses of LASN01
DRUG	LASN01	LASN01 will be administered intravenously
DRUG	Placebo	Escalating doses of matching placebo
DRUG	Placebo	Placebo will be administered intravenously

Timeline

• Start date: 2022-06-06
• Primary completion: 2024-11-27
• Completion: 2024-11-27
• First posted: 2022-04-15
• Last updated: 2024-12-30

Locations

4 sites across 2 countries: Australia, Hong Kong