Pulmonary FibrosisPhase 1/2NCT05331300
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
A Phase 1/2 study testing LASN01 in people with Pulmonary Fibrosis and Thyroid Eye Disease, run by Lassen Therapeutics 1 PTY LTD at 4 sites in 2 countries.
Trial 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 four-part trial consisting of Parts A, B, C and D. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Fibrosis, Thyroid Eye Disease
- What is being tested?
- LASN01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 6 Jun 2022to 27 Nov 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
- 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 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 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 Criteria:
- 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 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-point decrease 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, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months before Screening
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Australia3 sites
Site AU03
Brisbane, Queensland, 4006
Site AU05
Hurstville, New South Wales, 2220
Site AU01
Melbourne, Victoria, 3220
About this study
Official 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
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 four-part trial consisting of Parts A, B, C and D.
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.
Read the 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-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
- Pulmonary Fibrosis, Thyroid Eye Disease
- Being tested
- LASN01, Placebo
- Medical subject headings
- Pulmonary Fibrosis, Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LASN01Drug
Escalating single and multiple doses of LASN01
LASN01Drug
LASN01 will be administered intravenously
PlaceboDrug
Escalating doses of matching placebo
PlaceboDrug
Placebo will be administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| LASN01 - Parts A and B [Healthy Volunteers] | Experimental | Not described Receives: Drug: LASN01 |
| Placebo - Parts A and B [Healthy Volunteers] | Placebo comparator | Not described Receives: Drug: Placebo |
| LASN01 - Part C [Pulmonary Fibrosis] | Experimental | Not described Receives: Drug: LASN01 |
| Placebo - Part C [Pulmonary Fibrosis] | Placebo comparator | Not described Receives: Drug: Placebo |
| LASN01 - Part D [Thyroid Eye Disease] | Experimental | Not described Receives: Drug: LASN01 |
| Placebo - Part D [Thyroid Eye Disease] | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment emergent, treatment related, and serious adverse events
Measured: 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
Changes in concomitant medications
Measured: 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
Changes from Baseline in clinical laboratory evaluations following study drug administration
Measured: 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
Changes from Baseline in vital signs following study drug administration
Measured: 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
Changes from Baseline in 12-lead electrocardiogram (ECG) parameters following study drug administration
Measured: 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
Changes from Baseline in physical examination (PE) results following study drug administration
Measured: 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 outcomes (8)
PK parameter assessed by serum LASN01 concentration at specified timepoints for maximum plasma concentration (Cmax)
Measured: 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
PK parameter assessed by serum LASN01 concentration at specified timepoints for time to peak concentration (T max)
Measured: 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
PK parameter assessed by serum LASN01 concentration at specified timepoints for area under curve (AUC)
Measured: 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
PK parameter assessed by serum LASN01 concentration at specified timepoints for clearance volume (CL)
Measured: 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
PK parameter assessed by serum LASN01 concentration at specified timepoints for terminal phase volume (Vz)
Measured: 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
PK parameter assessed by serum LASN01 concentration at specified timepoints for half life ( t1/2).
Measured: 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
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
Measured: Week 1-Week 29 in Part D
Mean change from baseline in proptosis of LASN01 patients versus placebo patients
Measured: Day 1- Day 365 in Part D
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start6 Jun 2022
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lassen Therapeutics 1 PTY LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331300
- Sponsor's protocol ID
- LASN01-CL-1101
- Status last verified
- Dec 2024
- First submitted
- 16 Mar 2022
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05331300
- Acronym / sponsor ID
- LASN01-CL-1101
- Conditions
- Pulmonary Fibrosis, Thyroid Eye Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Lassen Therapeutics 1 PTY LTDIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 four-part trial consisting of Parts A, B, C and D.
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
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-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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LASN01 - Parts A and B [Healthy Volunteers] | Experimental | Drug: LASN01 |
| Placebo - Parts A and B [Healthy Volunteers] | Placebo comparator | Drug: Placebo |
| LASN01 - Part C [Pulmonary Fibrosis] | Experimental | Drug: LASN01 |
| Placebo - Part C [Pulmonary Fibrosis] | Placebo comparator | Drug: Placebo |
| LASN01 - Part D [Thyroid Eye Disease] | Experimental | Drug: LASN01 |
| Placebo - Part D [Thyroid Eye Disease] | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LASN01Escalating single and multiple doses of LASN01 | Drug | LASN01 - Parts A and B [Healthy Volunteers] |
| LASN01LASN01 will be administered intravenously | Drug | LASN01 - Part C [Pulmonary Fibrosis], LASN01 - Part D [Thyroid Eye Disease] |
| PlaceboEscalating doses of matching placebo | Drug | Placebo - Parts A and B [Healthy Volunteers] |
| PlaceboPlacebo will be administered intravenously | Drug | Placebo - Part C [Pulmonary Fibrosis], Placebo - Part D [Thyroid Eye Disease] |
Primary outcome
Treatment emergent, treatment related, and serious adverse events
Time frame: 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
Changes in concomitant medications
Time frame: 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
Changes from Baseline in clinical laboratory evaluations following study drug administration
Time frame: 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
Changes from Baseline in vital signs following study drug administration
Time frame: 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
Changes from Baseline in 12-lead electrocardiogram (ECG) parameters following study drug administration
Time frame: 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
Changes from Baseline in physical examination (PE) results following study drug administration
Time frame: 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
8 secondary outcomes
PK parameter assessed by serum LASN01 concentration at specified timepoints for maximum plasma concentration (Cmax)
Time frame: 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
PK parameter assessed by serum LASN01 concentration at specified timepoints for time to peak concentration (T max)
Time frame: 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
PK parameter assessed by serum LASN01 concentration at specified timepoints for area under curve (AUC)
Time frame: 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
PK parameter assessed by serum LASN01 concentration at specified timepoints for clearance volume (CL)
Time frame: 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
PK parameter assessed by serum LASN01 concentration at specified timepoints for terminal phase volume (Vz)
Time frame: 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
PK parameter assessed by serum LASN01 concentration at specified timepoints for half life ( t1/2).
Time frame: 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
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
Time frame: Week 1-Week 29 in Part D
Mean change from baseline in proptosis of LASN01 patients versus placebo patients
Time frame: Day 1- Day 365 in Part D
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LASN01 in people with Pulmonary Fibrosis and Thyroid Eye Disease, run by Lassen Therapeutics 1 PTY LTD at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment emergent, treatment related, and serious adverse events (time frame: 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.