Status:
COMPLETED
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
Lead Sponsor:
Lassen Therapeutics 1 PTY LTD
Conditions:
Pulmonary Fibrosis
Thyroid Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 fou...
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-d...
Eligibility Criteria
Inclusion
- I. Participant Inclusion Criteria-
- 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)
- IPF-specific
- A diagnosis of IPF
- IPF has been stable for ≥3 months at Screening
- PF-ILD-specific
- 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
- Part D only
- Male or female patients of age ≥18 years
- Clinical diagnosis of Graves' disease associated with active TED
- Moderate-to-severe active TED
- Less than 15 months from onset of TED in the study eye
- 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
- 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
- IPF-specific
Exclusion
- 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
- 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
Key Trial Info
Start Date :
June 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2024
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05331300
Start Date
June 6 2022
End Date
November 27 2024
Last Update
December 30 2024
Active Locations (4)
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1
Site AU05
Hurstville, New South Wales, Australia, 2220
2
Site AU03
Brisbane, Queensland, Australia, 4006
3
Site AU01
Melbourne, Victoria, Australia, 3220
4
Site HK01
Shatin, Hong Kong