Phase
Condition
Scar Tissue
Dry Eye Disease
Cystic Fibrosis
Treatment
LASN01
Placebo
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
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 ofcontraception or a highly effective method of contraception. Males must besurgically sterile for ≥6 months or agree to highly effective methods ofcontraception.
Able to comprehend and willing to sign an ICF and understand and comply with therequirements 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 18through 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-ILDpatients) IPF-specific Inclusion Criteria:
A diagnosis of IPF
IPF has been stable for ≥3 months at Screening PF-ILD-specific Inclusion Criteria:
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.
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 newtherapy 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 supportivemeasures, 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 toparticipate 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 drugcompound, 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 theexception 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 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
History of clinically relevant cardiovascular disease that could jeopardize apatient's health during the course of the study
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:
FVC <45% predicted of normal or a forced expiratory volume during the first secondof 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 consecutivemonths or needed dose modification due to AEs in the last 3 months PF-ILD-specific Exclusion Criteria:
Diagnosis of IPF
Diagnosis of sarcoidosis
Significant pulmonary arterial hypertension
FVC <45% predicted of normal or a FEV1/FVC ratio of <0.7
Previous treatment with pirfenidone Part D only
Any previous use of anti-insulin-like growth factor 1 receptor monoclonal antibody (eg, teprotumumab) at any time
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
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
Study Description
Connect with a study center
Site AU07
Botany, New South Wales 2019
AustraliaSite Not Available
Site AU05
Hurstville, New South Wales 2220
AustraliaSite Not Available
Nucleus Network
Brisbane, Queensland 4006
AustraliaActive - Recruiting
Site AU03
Brisbane, Queensland 4006
AustraliaSite Not Available
The Prince Charles Hospital
Brisbane, Queensland 4032
AustraliaSite Not Available
Prince Charles
Chermside, Queensland 4032
AustraliaSite Not Available
Site AU06
Camberwell, Victoria 3124
AustraliaSite Not Available
Nucleus Network Pty Ltd.
Geelong, Victoria 3220
AustraliaSite Not Available
Alfred Hospital
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Jason Lickliter
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Nucleus Network Pty Ltd.
Melbourne, Victoria 3220
AustraliaActive - Recruiting
Site AU01
Melbourne, Victoria 3220
AustraliaSite Not Available
Site HK01
Hong Kong,
Hong KongSite Not Available
Site HK01
Sha Tin,
Hong KongSite Not Available
Site NZ02
Auckland, 0622
New ZealandSite Not Available
Site NZ01
Wellington, 6021
New ZealandSite Not Available
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