A Study to Evaluate the Safety, Preliminary Efficacy, and Pharmacokinetic Properties of LASN01 in… (NCT05331300) | Clinical Trial Compass
CompletedPhase 1/2
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
Australia, Hong Kong75 participantsStarted 2022-06-06
Plain-language 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.
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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
✓. Male and female patients \>40 years of age (IPF patients) or ≥21 years of age (PF-ILD patients)
✓. A diagnosis of IPF
✓. IPF has been stable for ≥3 months at Screening
Exclusion criteria
✕
What they're measuring
1
Treatment emergent, treatment related, and serious adverse events
Timeframe: 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
2
Changes in concomitant medications
Timeframe: 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
3
Changes from Baseline in clinical laboratory evaluations following study drug administration
Timeframe: 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
4
Changes from Baseline in vital signs following study drug administration
Timeframe: 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
5
Changes from Baseline in 12-lead electrocardiogram (ECG) parameters following study drug administration
Timeframe: 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
6
Changes from Baseline in physical examination (PE) results following study drug administration
Timeframe: 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
. Any acute or chronic condition that would limit the participant's ability to participate in and complete this clinical study
✕. 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