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
NCT ID: NCT05331300
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
75 participants
INTERVENTIONAL
2022-06-06
2024-11-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LASN01 - Parts A and B [Healthy Volunteers]
LASN01
Escalating single and multiple doses of LASN01
Placebo - Parts A and B [Healthy Volunteers]
Placebo
Escalating doses of matching placebo
LASN01 - Part C [Pulmonary Fibrosis]
LASN01
LASN01 will be administered intravenously
Placebo - Part C [Pulmonary Fibrosis]
Placebo
Placebo will be administered intravenously
LASN01 - Part D [Thyroid Eye Disease]
LASN01
LASN01 will be administered intravenously
Placebo - Part D [Thyroid Eye Disease]
Placebo
Placebo will be administered intravenously
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LASN01
Escalating single and multiple doses of LASN01
LASN01
LASN01 will be administered intravenously
Placebo
Escalating doses of matching placebo
Placebo
Placebo will be administered intravenously
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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)
7. A diagnosis of IPF
8. IPF has been stable for ≥3 months at Screening
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. 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 supportive measures, mycophenolate and oral or injectable steroids, immunomodulating therapies, and/or orbital irradiation/radiotherapy
Exclusion Criteria
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
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
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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Lassen Therapeutics 1 PTY LTD
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Site AU05
Hurstville, New South Wales, Australia
Site AU03
Brisbane, Queensland, Australia
Site AU01
Melbourne, Victoria, Australia
Site HK01
Shatin, , Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LASN01-CL-1101
Identifier Type: -
Identifier Source: org_study_id