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

Study Purpose

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, tolerability, and the secondary objective is to evaluate the 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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

I. Participant Inclusion Criteria- Parts A, B, C, and D.

1. Female participants must be nonpregnant, nonlactating, and either postmenopausal for ≥12 months, surgically sterile for ≥6 months, or agree to use 2 effective methods of contraception or a highly effective method of contraception. Males must be surgically sterile for ≥6 months or agree to highly effective methods of contraception. 2. Able to comprehend and willing to sign an ICF and understand and comply with the requirements of the study. Part A and Part B only. 3. Males or females, 18 through 60 years of age, inclusive. 4. Body weight ≥110 pounds (≥50 kg); body mass index (BMI) within the range of 18 through 32.0 kg/m2. 5. In good health as determined by the Investigator. Part C only. 6. Male and female patients >40 years of age (IPF patients) or ≥21 years of age (PF-ILD patients) IPF-specific

Inclusion Criteria:

7. A diagnosis of IPF. 8. IPF has been stable for ≥3 months at Screening. PF-ILD-specific

Inclusion Criteria:

9. Patients with physician diagnosed ILD who fulfill ≥1 of the following criteria for PF-ILD within 24 months of the Screening visit despite treatment with approved and/or unapproved medications used in clinical practice to treat ILD. 10. Fibrosing lung disease on HRCT performed within 3 years of the Screening Visit. 11. For patients with underlying CTD: stable CTD as defined by no initiation of new therapy or withdrawal of therapy for CTD within 6 weeks before the Screening visit. 12. FVC ≥45% predicted. Part D only. 13. Age 18 through 80 years, inclusive. 14. Clinical diagnosis of Graves' disease associated with active TED. 15. Moderate-to-severe active TED. 16. Less than 15 months from onset of TED in the study eye. 17. No previous medical treatment for TED with the exception of local supportive measures, mycophenolate and oral or injectable steroids, immunomodulating therapies, and/or orbital irradiation/radiotherapy.

II. Participant Exclusion Criteria.

Parts A, B, C, and D. 1. Any acute or chronic condition that would limit the participant's ability to participate in and complete this clinical study. Part A and Part B only. 2. Significant history or clinical manifestation of any significant endocrine, metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder. 3. History of significant hypersensitivity; intolerance; or allergy to any drug compound, food, or other substance; or history of anaphylaxis or angioedema. 4. Positive serum test for HIV or hepatitis infection. 5. Currently receiving any antibiotics for upper or lower respiratory tract infections. 6. Use of any prescription drug or vaccine within 21 days before Check-in with the exception of hormonal contraceptives and vaccines. 7. Any prescription biologic within 3 months or 5 half-lives (whichever is greater) before Check-in. 8. Participation in any other investigational study drug trial in which an investigational study drug was administered within 30 days before randomization or an investigational biological study drug was administered within 3 months before Check-in. Part C only. 9. History of clinically relevant cardiovascular disease that could jeopardize a patient's health during the course of the study. 10. Patients with concurrent active malignancy other than adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix. IPF-specific

Exclusion Criteria:

11. FVC <45% predicted of normal or a forced expiratory volume during the first second of the forced breath (FEV1)/FVC ratio of <0.7. 12. Extent of emphysema in the lungs exceeds fibrosis. 13. Currently receiving pirfenidone or nintedanib if on treatment for <3 consecutive months or needed dose modification due to AEs in the last 3 months. PF-ILD-specific

Exclusion Criteria:

14. Diagnosis of IPF. 15. Diagnosis of sarcoidosis. 16. Significant pulmonary arterial hypertension. 17. FVC <45% predicted of normal or a FEV1/FVC ratio of <0.7. 18. Previous treatment with pirfenidone. Part D only. 19. Any previous use of anti-insulin-like growth factor 1 receptor monoclonal antibody (eg, teprotumumab) at any time. 20. Patients with 2 mm proptosis decrease between Screening and Baseline, or a 1-point decrease on the CAS 7-point scale in any 2 weeks during the Screening period. 21. Patients with decreased best corrected visual acuity due to optic neuropathy, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months before Screening

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05331300
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Lassen Therapeutics 1 PTY LTD
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Hong Kong, New Zealand
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Fibrosis, Thyroid Eye Disease

Additional Details

This clinical trial (LASN01-CL-1101) consists of 4 parts, each part containing adaptive design elements that can be modified. Part A will comprise a single-dose administration in healthy participants in 5 dose cohorts. Part B will comprise a multiple-dose administration in healthy participants in 2 dose cohorts. Part C will comprise a multiple-dose administration in a single cohort of approximately 8 to 12 participants. Part D will comprise a multiple-dose design in a single cohort of approximately 8 to 12 participants. In each part of the study, participants will be randomized to receive IV doses of LASN01 or placebo.

Arms & Interventions

Arms

Experimental: LASN01

Placebo Comparator: Placebo

Interventions

Drug: - LASN01

Escalating doses of LASN01 will be given in different cohorts of Parts A, B, C and D.

Drug: - Placebo

Escalating doses of matching placebo will be given in different cohorts of Parts A, B, C and D.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.