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

Last updated: December 23, 2024
Sponsor: Lassen Therapeutics 1 PTY LTD
Overall Status: Completed

Phase

1/2

Condition

Scar Tissue

Dry Eye Disease

Cystic Fibrosis

Treatment

LASN01

Placebo

Clinical Study ID

NCT05331300
LASN01-CL-1101
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 ofcontraception or a highly effective method of contraception. Males must besurgically sterile for ≥6 months or agree to highly effective methods ofcontraception.

  2. Able to comprehend and willing to sign an ICF and understand and comply with therequirements 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 18through 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-ILDpatients) 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 forPF-ILD within 24 months of the Screening visit despite treatment with approvedand/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 newtherapy or withdrawal of therapy for CTD within 6 weeks before the Screening visit

  12. FVC ≥45% predicted Part D only

  13. Male or female patients of age ≥18 years

  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 supportivemeasures, 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 toparticipate 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 drugcompound, 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 theexception 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 aninvestigational study drug was administered within 30 days before randomization oran investigational biological study drug was administered within 3 months beforeCheck-in Part C only

  9. History of clinically relevant cardiovascular disease that could jeopardize apatient's health during the course of the study

  10. Patients with concurrent active malignancy other than adequately treated basal cellcarcinoma of the skin or carcinoma in situ of the cervix

Exclusion

IPF-specific Exclusion Criteria:

  1. FVC <45% predicted of normal or a forced expiratory volume during the first secondof the forced breath (FEV1)/FVC ratio of <0.7

  2. Extent of emphysema in the lungs exceeds fibrosis

  3. Currently receiving pirfenidone or nintedanib if on treatment for <3 consecutivemonths or needed dose modification due to AEs in the last 3 months PF-ILD-specific Exclusion Criteria:

  4. Diagnosis of IPF

  5. Diagnosis of sarcoidosis

  6. Significant pulmonary arterial hypertension

  7. FVC <45% predicted of normal or a FEV1/FVC ratio of <0.7

  8. Previous treatment with pirfenidone Part D only

  9. Any previous use of anti-insulin-like growth factor 1 receptor monoclonal antibody (eg, teprotumumab) at any time

  10. Patients with 2 mm proptosis decrease between Screening and Baseline, or a 1-pointdecrease on the CAS 7-point scale in any 2 weeks during the Screening period

  11. Patients with decreased best corrected visual acuity due to optic neuropathy, newvisual field defect, or color defect secondary to optic nerve involvement within thelast 6 months before Screening

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: LASN01
Phase: 1/2
Study Start date:
June 06, 2022
Estimated Completion Date:
November 27, 2024

Study 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.

Connect with a study center

  • Site AU07

    Botany, New South Wales 2019
    Australia

    Site Not Available

  • Site AU05

    Hurstville, New South Wales 2220
    Australia

    Site Not Available

  • Nucleus Network

    Brisbane, Queensland 4006
    Australia

    Active - Recruiting

  • Site AU03

    Brisbane, Queensland 4006
    Australia

    Site Not Available

  • The Prince Charles Hospital

    Brisbane, Queensland 4032
    Australia

    Site Not Available

  • Prince Charles

    Chermside, Queensland 4032
    Australia

    Site Not Available

  • Site AU06

    Camberwell, Victoria 3124
    Australia

    Site Not Available

  • Nucleus Network Pty Ltd.

    Geelong, Victoria 3220
    Australia

    Site Not Available

  • Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Jason Lickliter

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Nucleus Network Pty Ltd.

    Melbourne, Victoria 3220
    Australia

    Active - Recruiting

  • Site AU01

    Melbourne, Victoria 3220
    Australia

    Site Not Available

  • Site HK01

    Hong Kong,
    Hong Kong

    Site Not Available

  • Site HK01

    Sha Tin,
    Hong Kong

    Site Not Available

  • Site NZ02

    Auckland, 0622
    New Zealand

    Site Not Available

  • Site NZ01

    Wellington, 6021
    New Zealand

    Site Not Available

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