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

I. Participant Inclusion Criteria-

Parts A, B, C, and D

1. Participants who are women of child-bearing potential (WOCBP) with male partners and
WOCBP partners of male participants must be nonpregnant, nonlactating, and use 2
effective methods of contraception or a highly effective method 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

6. Clinical laboratory evaluations within the reference range for the test laboratory,
unless deemed not clinically significant by the Investigator

Part C only

7. Male and female patients >40 years of age (IPF patients) or ≥21 years of age (PF-ILD
patients)

IPF-specific Inclusion Criteria:

8. As determined by the PI, a diagnosis of IPF in accordance with the 2018 American
Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin
American Thoracic Society Clinical Practice Guideline on Diagnosis of IPF (Raghu 2018)

9. IPF has, in the opinion of the Investigator, been stable for ≥3 months at Screening

PF-ILD-specific Inclusion Criteria:

10. 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, as assessed by the
Investigator

11. Fibrosing lung disease on HRCT performed within 3 years of the Screening Visit meeting
the following criteria based on site multidisciplinary team review. If an initial or
repeat HRCT scan within a 12-month window is not available, a repeat HRCT scan will be
obtained during Screening:

1. Presence of HRCT pattern of usual interstitial pneumonia

2. Presence of reticular abnormality with traction bronchiectasis

3. Presence definite honeycomb lung destruction with basal and peripheral
predominance

4. Disease extent >10% of total lung parenchyma

5. Absence of widespread consolidation or progressive massive fibrosis

12. 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

13. FVC ≥45% predicted

Part D only

14. Age 18 through 80 years, inclusive

15. Clinical diagnosis of Graves' disease associated with active TED

16. Moderate-to-severe active TED

17. Less than 12 months from onset of TED

18. No previous:

- Medical treatment for TED, excluding local supportive measures, mycophenolate,
and oral or injectable steroids if the maximum cumulative dose is ≤3g
methylprednisolone or equivalent with ≥6 weeks between last administration of
oral steroids and/or mycophenolate and Screening

- Surgical treatment in the study eye

- Orbital radiation

II. Participant Exclusion Criteria

Parts A, B, C, and D

1. Positive polymerase chain reaction (PCR) test for severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) at Screening or Day -1 or within 72 hours before
randomization, or positive antigen test on Day -1 or Day 1, or acute infection with
SARS-CoV-2 within last 3 months

2. Any acute or chronic condition that, in the opinion of the Investigator, would limit
the participant's ability to participate in and complete this clinical study

Part A and Part B only

3. Significant history or clinical manifestation of any significant endocrine, metabolic,
allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,
gastrointestinal, neurological, or psychiatric disorder, as determined by the
Investigator

4. History of significant hypersensitivity; intolerance; or allergy to any drug compound,
food, or other substance; or history of anaphylaxis or angioedema, as determined by
the Investigator

5. Any Screening laboratory evaluation outside the laboratory reference range except
those the Investigator determines not to be clinically significant and laboratory
tests for which limits are otherwise defined

6. Positive serum test for HIV or hepatitis infection

7. Currently receiving any antibiotics for upper or lower respiratory tract infections

8. Use of any prescription drug or vaccine within 21 days before Check-in

- EXCEPTIONS: oral, implantable, transdermal, or injectable contraceptives, or
NuvaRing® are permitted)

- EXCEPTIONS: killed and inactive vaccines, including mRNA vaccines (eg, pneumonia,
influenza, SARS-CoV-2) and live attenuated vaccines (eg, varicella) are
permitted, but should have been completed ≥14 days before Screening

9. Any prescription biologic within 3 months or 5 half-lives (whichever is greater)
before Check-in

10. 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

11. History of clinically relevant cardiovascular disease that could jeopardize a
patient's health during the course of the study as determined by the Investigator

12. 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:

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

14. Extent of emphysema in the lungs exceeds fibrosis, based on review of HRCT conducted
within the last 3 years

15. 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:

16. Diagnosis of IPF based on American Thoracic Society/European Respiratory
Society/Japanese Respiratory Society/Latin American Thoracic Association 2018
Guidelines (Raghu 2018)

17. Diagnosis of sarcoidosis

18. Significant pulmonary arterial hypertension defined by any of the following:

1. Previous clinical or echocardiographic evidence of significant right heart
failure

2. History of right heart catheterization showing a cardiac index ≤2 L/min/m²

3. Pulmonary arterial hypertension requiring therapy with epoprostenol/treprostinil

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

20. Previous treatment with pirfenidone. Current or previous treatment with nintedanib is
permissible in countries where it is approved for treatment of PF-ILD; patients
currently being treated with nintedanib must be on stable treatment for ≥3 months with
no change in dose during that period

Part D only

21. Any previous use of teprotumumab at any time; previous use of rituximab, tocilizumab,
or any monoclonal antibody for immunomodulation within the past 9 months before
randomization; or previous use of any other immunomodulating therapy within 3 months
before randomization unless approved by the Medical Monitor.

22. 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

23. Patients with decreased best corrected visual acuity due to optic neuropathy as
defined by a decrease in vision of 2 lines on the Snellen chart, new visual field
defect, or color defect secondary to optic nerve involvement within the last 6 months
before Screening