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

Pulmonary Fibrosis Clinical Trial

Official title:
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 Recruiting

Clinical Trial 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 the Phase 1 (single and multiple ascending dose, SAD/MAD) portion in healthy subjects is completed and the Phase 2a portion in patients is actively recruiting.

Clinical Trial 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 will comprise a multiple-dose administration in a single cohort of approximately 12 to 16 patients with IPF and PF-ILD, and Part D will comprise a multiple-dose design in a single cohort of approximately 12 to 16 patients with TED. In each part of the study, participants will be randomized to receive IV doses of LASN01 or placebo. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05331300
Study type	Interventional
Source	Lassen Therapeutics Inc.
Contact	Lassen Therapeutics
Phone	+1 858 251-7528
Email	CL-1101@lassentherapeutics.com
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	June 6, 2022
Completion date	September 2025

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.