临床试验/NCT05954988

NCT05954988已完成1 期

A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Safety, Tolerability and Pharmacodynamic Biomarker Study of Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) in Recently Diagnosed, Treatment Naïve Subjects With IPF

Rein Therapeutics7 个研究点分布在 3 个国家目标入组 24 人开始时间: 2023年7月6日最近更新: 2025年7月31日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Rein Therapeutics
入组人数: 24
试验地点: 7
主要终点: Incidence of Treatment-emergent Adverse Events (TEAEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

This study will assess the safety and tolerability of inhaled LTI-03 in treatment naïve participants with newly diagnosed IPF.

详细描述

This is a randomized, double-blind, placebo controlled, multi-center, dose escalation, safety and tolerability study of LTI-03 or placebo administered by inhalation in participants recently diagnosed with idiopathic pulmonary fibrosis that have not received prior treatment with anti-fibrotic agents.

The study will contain 2 dose cohorts which will run sequentially.

Eligible participants will be randomized in a 3:1 ratio to either LTI-03 or placebo. Safety data will be reviewed on an ongoing basis. Enrollment in the second cohort will not begin until the Cohort 1 safety data has been reviewed.

The Treatment Period will be 14 days, with subjects self-administering study drug using a provided commercially available dry-powder inhaler.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Sequential
主要目的: Other
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

The Sponsor, Investigator, and study personnel working on behalf of the Investigator and Sponsor will remain blinded.

入排标准

年龄范围: 40 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male or female subject of age 40 years or older.
•Willing and able to provide written informed consent.
•Diagnosis of IPF within 3 years of Screening as confirmed by HRCT of chest or lung biopsy as defined by ATS/ERS/JRS/ALAT guideline.
•Forced vital capacity (FVC) percent predicted ≥ 40%.
•Diffusion capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥ 30 and ≤
•Forced expiratory volume 1 (FEV1)/FVC ≥ 0.7.

排除标准

•Interstitial lung disease other than IPF.
•Evidence of significant obstructive lung disease.
•Current diagnosis of asthma.
•Treatment with an approved or investigational antifibrotic therapy for IPF within 2 months of the Baseline bronchoscopy.
•Use of N-acetyl cysteine or other supplements within 7 days prior to dosing and throughout the Treatment Period.
•Inability to use study inhaler device appropriately.
•Pulmonary exacerbation within 6 months prior to Screening.
•Febrile illness within 7 days prior to dosing.
•Participation in a clinical study or treatment with an investigational drug or device within 30 days of the Screening Visit (or 5 half-lives of the investigational agent, whichever is longer).
•History or evidence at screening of significant renal impairment with eGFR < 30 mL/min (region specific).
•History or evidence at screening of significant hepatic impairment with bilirubin > 3 mg/dL (> 51.3 µmol/L) and albumin < 2.8 g/dL (<28 g/L) and PT prolongation > 6 sec or INR > 2.3 (region specific).
•Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol.
•Vaccination within 2 weeks of start of dosing (Day 1) and throughout the Treatment Period.
•Subject has severe progressive or uncontrolled, clinically significant disease that in the judgment of the investigator or designee renders the subject unsuitable for the study.
•Positive urine pregnancy test in female subjects of childbearing potential as defined below.
•Female subjects who are lactating.
•Females of childbearing potential (FOCBP) and men with partners of childbearing potential who do not agree to use an acceptable form of contraception for the duration of study treatment and for at least 90 days after the last dose of study drug. Male subjects who do not agree to refrain from donating sperm during this same period.

研究组 & 干预措施

2.5 mg LTI-03 BID

Experimental

2.5 mg LTI-03 BID x 14 days

干预措施: LTI-03 (Drug)

5 mg LTI-03 BID

Experimental

5 mg LTI-03 BID x 14 days

干预措施: LTI-03 (Drug)

Placebo

Placebo Comparator

Matching placebo BID x 14 days

干预措施: Placebo (Drug)

结局指标

主要结局

Incidence of Treatment-emergent Adverse Events (TEAEs)

时间窗: 21 days (dosing x 14 days; follow up x 7 days)

Incidence of TEAEs by dose

次要结局

未报告次要终点

研究者

发起方

Rein Therapeutics

申办方类型

Industry

责任方

Sponsor

研究点 (7)

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