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

NCT05331300 | Completed Phase 1

• 1 other identifier: LASN01-CL-1101
• Study Type: interventional
• Target: 75
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Pulmonary Fibrosis; Thyroid Eye Disease

Outcome Measures

Primary Outcomes (6)

• Treatment emergent, treatment related, and serious adverse events

  Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1-Day 365 in Part D

• Changes in concomitant medications

  Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1-Day 365 in Part D

• Changes from Baseline in clinical laboratory evaluations following study drug administration

  Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1-Day 365 in Part D

• Changes from Baseline in vital signs following study drug administration

  Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1-Day 365 in Part D

• Changes from Baseline in 12-lead electrocardiogram (ECG) parameters following study drug administration

  Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1-Day 365 in Part D

• Changes from Baseline in physical examination (PE) results following study drug administration

  Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1-Day 365 in Part D

Secondary Outcomes (8)

• PK parameter assessed by serum LASN01 concentration at specified timepoints for maximum plasma concentration (Cmax)

  Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1- Day 365 in Part D

• PK parameter assessed by serum LASN01 concentration at specified timepoints for time to peak concentration (T max)

  Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1- Day 365 in Part D

• PK parameter assessed by serum LASN01 concentration at specified timepoints for area under curve (AUC)

  Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1- Day 365 in Part D

• PK parameter assessed by serum LASN01 concentration at specified timepoints for clearance volume (CL)

  Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1- Day 365 in Part D

• PK parameter assessed by serum LASN01 concentration at specified timepoints for terminal phase volume (Vz)

  Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1- Day 365 in Part D

Study Arms (6)

LASN01 - Parts A and B [Healthy Volunteers]

EXPERIMENTAL

Drug: LASN01

Placebo - Parts A and B [Healthy Volunteers]

PLACEBO COMPARATOR

Drug: Placebo

LASN01 - Part C [Pulmonary Fibrosis]

EXPERIMENTAL

Drug: LASN01

Placebo - Part C [Pulmonary Fibrosis]

PLACEBO COMPARATOR

Drug: Placebo

LASN01 - Part D [Thyroid Eye Disease]

EXPERIMENTAL

Drug: LASN01

Placebo - Part D [Thyroid Eye Disease]

PLACEBO COMPARATOR

Drug: Placebo

Interventions

LASN01 DRUG

Escalating single and multiple doses of LASN01

LASN01 - Parts A and B [Healthy Volunteers]

Placebo DRUG

Escalating doses of matching placebo

Placebo - Parts A and B [Healthy Volunteers]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parts A, B, C, and D
• 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.
• 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
• Males or females, 18 through 60 years of age, inclusive
• Body weight ≥110 pounds (≥50 kg); body mass index (BMI) within the range of 18 through 32.0 kg/m2
• In good health as determined by the Investigator
• Part C only
• Male and female patients \>40 years of age (IPF patients) or ≥21 years of age (PF-ILD patients)
• A diagnosis of IPF
• IPF has been stable for ≥3 months at Screening
• 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.
• Fibrosing lung disease on HRCT performed within 3 years of the Screening Visit
• 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
• FVC ≥45% predicted

You may not qualify if:

• Parts A, B, C, and D
• 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
• Significant history or clinical manifestation of any significant endocrine, metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder
• History of significant hypersensitivity; intolerance; or allergy to any drug compound, food, or other substance; or history of anaphylaxis or angioedema
• Positive serum test for HIV or hepatitis infection
• Currently receiving any antibiotics for upper or lower respiratory tract infections
• Use of any prescription drug or vaccine within 21 days before Check-in with the exception of hormonal contraceptives and vaccines.
• Any prescription biologic within 3 months or 5 half-lives (whichever is greater) before Check-in
• 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
• History of clinically relevant cardiovascular disease that could jeopardize a patient's health during the course of the study
• Patients with concurrent active malignancy other than adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
• FVC \<45% predicted of normal or a forced expiratory volume during the first second of the forced breath (FEV1)/FVC ratio of \<0.7
• Extent of emphysema in the lungs exceeds fibrosis

Sponsors & Collaborators

• Lassen Therapeutics 1 PTY LTD: lead

Study Sites (4)

Site AU05

Hurstville, New South Wales, 2220, Australia

Location

Site AU03

Brisbane, Queensland, 4006, Australia

Location

Site AU01

Melbourne, Victoria, 3220, Australia

Location

Site HK01

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Pulmonary Fibrosis; Graves Ophthalmopathy

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Eye Diseases, Hereditary; Eye Diseases; Graves Disease; Exophthalmos; Orbital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: April 15, 2022
• Study Start: June 6, 2022
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); HK (1)