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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05331300




Registration number
NCT05331300
Ethics application status
Date submitted
16/03/2022
Date registered
15/04/2022

Titles & IDs
Public title
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
Scientific title
A Phase 1/2a, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Preliminary Efficacy, Immunogenicity and Pharmacokinetic Properties of LASN01 in Healthy Subjects and in Patients With Pulmonary Fibrosis or Thyroid Eye Disease
Secondary ID [1] 0 0
LASN01-CL-1101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Fibrosis 0 0
Thyroid Eye Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Eye 0 0 0 0
Diseases / disorders of the eye
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LASN01
Treatment: Drugs - LASN01
Treatment: Drugs - Placebo
Treatment: Drugs - Placebo

Experimental: LASN01 - Parts A and B [Healthy Volunteers] - Completed/Closed to enrollment

Placebo comparator: Placebo - Parts A and B [Healthy Volunteers] - Completed/Closed to enrollment

Experimental: LASN01 - Part C [Pulmonary Fibrosis] - Closed to enrollment

Placebo comparator: Placebo - Part C [Pulmonary Fibrosis] - Closed to enrollment

Experimental: LASN01 - Part D [Thyroid Eye Disease] - Closed to enrollment

Placebo comparator: Placebo - Part D [Thyroid Eye Disease] - Closed to enrollment


Treatment: Drugs: LASN01
Escalating single and multiple doses of LASN01

Treatment: Drugs: LASN01
LASN01 will be administered intravenously

Treatment: Drugs: Placebo
Escalating doses of matching placebo

Treatment: Drugs: Placebo
Placebo will be administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Treatment emergent, treatment related, and serious adverse events
Timepoint [1] 0 0
Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1-Day 365 in Part D
Primary outcome [2] 0 0
Changes in concomitant medications
Timepoint [2] 0 0
Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1-Day 365 in Part D
Primary outcome [3] 0 0
Changes from Baseline in clinical laboratory evaluations following study drug administration
Timepoint [3] 0 0
Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1-Day 365 in Part D
Primary outcome [4] 0 0
Changes from Baseline in vital signs following study drug administration
Timepoint [4] 0 0
Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1-Day 365 in Part D
Primary outcome [5] 0 0
Changes from Baseline in 12-lead electrocardiogram (ECG) parameters following study drug administration
Timepoint [5] 0 0
Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1-Day 365 in Part D
Primary outcome [6] 0 0
Changes from Baseline in physical examination (PE) results following study drug administration
Timepoint [6] 0 0
Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1-Day 365 in Part D
Secondary outcome [1] 0 0
PK parameter assessed by serum LASN01 concentration at specified timepoints for maximum plasma concentration (Cmax)
Timepoint [1] 0 0
Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1- Day 365 in Part D
Secondary outcome [2] 0 0
PK parameter assessed by serum LASN01 concentration at specified timepoints for time to peak concentration (T max)
Timepoint [2] 0 0
Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1- Day 365 in Part D
Secondary outcome [3] 0 0
PK parameter assessed by serum LASN01 concentration at specified timepoints for area under curve (AUC)
Timepoint [3] 0 0
Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1- Day 365 in Part D
Secondary outcome [4] 0 0
PK parameter assessed by serum LASN01 concentration at specified timepoints for clearance volume (CL)
Timepoint [4] 0 0
Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1- Day 365 in Part D
Secondary outcome [5] 0 0
PK parameter assessed by serum LASN01 concentration at specified timepoints for terminal phase volume (Vz)
Timepoint [5] 0 0
Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1- Day 365 in Part D
Secondary outcome [6] 0 0
PK parameter assessed by serum LASN01 concentration at specified timepoints for half life ( t1/2).
Timepoint [6] 0 0
Day 1-Day 57 in Part A, Day 1-Day 71 in Part B, Day 1-Day 211 in Part C, Day 1- Day 365 in Part D
Secondary outcome [7] 0 0
Percentage of patients with a =2 mm reduction from Baseline in proptosis in the study eye, (LASN01 versus placebo) without deterioration [=2 mm increase] of proptosis in the fellow eye at Week 29
Timepoint [7] 0 0
Week 1-Week 29 in Part D
Secondary outcome [8] 0 0
Mean change from baseline in proptosis of LASN01 patients versus placebo patients
Timepoint [8] 0 0
Day 1- Day 365 in Part D

Eligibility
Key inclusion criteria
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 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)

IPF-specific
7. A diagnosis of IPF
8. IPF has been stable for =3 months at Screening

PF-ILD-specific
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

II. Participant
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion Criteria

Parts A, B, C, and D

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

IPF-specific
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

PF-ILD-specific
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Site AU07 - Botany
Recruitment hospital [2] 0 0
Site AU05 - Hurstville
Recruitment hospital [3] 0 0
Site AU03 - Brisbane
Recruitment hospital [4] 0 0
Site AU06 - Camberwell
Recruitment hospital [5] 0 0
Site AU01 - Melbourne
Recruitment postcode(s) [1] 0 0
2019 - Botany
Recruitment postcode(s) [2] 0 0
2220 - Hurstville
Recruitment postcode(s) [3] 0 0
4006 - Brisbane
Recruitment postcode(s) [4] 0 0
3124 - Camberwell
Recruitment postcode(s) [5] 0 0
3220 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Sha Tin
Country [2] 0 0
New Zealand
State/province [2] 0 0
Auckland
Country [3] 0 0
New Zealand
State/province [3] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Lassen Therapeutics 1 PTY LTD
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lassen Therapeutics
Address 0 0
Country 0 0
Phone 0 0
+1 858 251-7528
Fax 0 0
Email 0 0
CL-1101@lassentherapeutics.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05331300