TRK-250 - A Phase I, Double-Blind, Placebo-Controlled, Single and Multiple Inhaled Dose, Safety, Tolerability, and Pharmacokinetic Study of TRK-250 in Subjects With Idiopathic Pulmonary Fibrosis

TRK-250 is a nucleic acid medicine that inhibits the progression of pulmonary fibrosis by selectively suppressing the expression of transforming growth factor-beta 1 (TGF-β1) protein, at the gene expression level. This study is a double-blind, randomized, placebo-controlled Phase I study. The primary objective of the study is to assess the safety and tolerability of single and multiple inhaled doses of TRK-250 in subjects with idiopathic pulmonary fibrosis (IPF).

开始日期2018-11-28

申办/合作机构

Toray Industries, Inc.

100 项与 TRK-250 相关的临床结果

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100 项与 TRK-250 相关的转化医学

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100 项与 TRK-250 相关的专利（医药）

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项与 TRK-250 相关的文献（医药）

2023-12-01·Journal of Aerosol Medicine and Pulmonary Drug Delivery

A Phase I Study of TRK-250, a Novel siRNA-Based Oligonucleotide, in Patients with Idiopathic Pulmonary Fibrosis

Article

作者: Baratz, David ; Doi, Hiroyuki ; Atsumi, Jun ; Miyamoto, Yohei

Purpose: TRK-250 is a novel single-stranded oligonucleotide carrying a human Transforming growth factor-beta 1-targeting siRNA motif tethered by two proline linkers. Nonclinical studies have shown that TRK-250 may have potency to prevent the progression of pulmonary fibrosis. Herein, a phase I study was conducted to investigate the safety and pharmacokinetics (PKs) of TRK-250 in patients with idiopathic pulmonary fibrosis (IPF). Method: In the phase I study, 34 IPF patients were partially randomized to receive a placebo or TRK-250 in 4 single doses of 2, 10, 30, and 60 mg or multiple rising doses of 10, 30, and 60 mg once per week for 4 weeks by oral inhalation. For both the single- and multiple-dose studies, the primary endpoint was safety, and the secondary endpoint was PKs. Result: In all IPF patients who orally inhaled TRK-250, no significant drug-related adverse events (AEs) were observed. The AEs were mild or moderate, except for one severe case with acute exacerbation. One of the more common AEs was coughing. One patient discontinued treatment before the last dose because of coughing. There were no medically important findings related to safety endpoints based on clinical laboratory data (clinical chemistry, hematology, or urinalysis), vital signs data, electrocardiogram data, physical examination findings, pulse oximetry data, spirometry data, or diffusing capacity of the lung for carbon monoxide data. All the bioanalytical results of PKs in the blood were below the lower limit of quantification. Conclusions: Both the single and multiple doses of TRK-250 were safe and well tolerated in this first study done in IPF patients. Furthermore, TRK-250 was not detected in the systemic circulation following inhalation, indicating low or virtually nonexistent systemic exposure. This study is registered at ClinicalTrials.gov with identifier number NCT03727802.

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
特发性肺纤维化	临床1期	美国	Toray Industries, Inc.	2018-11-28

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03727802 (CTgov)	临床1期	特发性肺纤维化	34	TRK-250 (PartA:TRK-250 2mg)	繭鑰製餘顧鬱製鹹憲襯(膚廠積積鏇鹽齋淵遞簾) = 艱積夢糧鹹選襯壓鹽膚齋壓構餘繭遞艱淵衊壓 (膚網遞鹽觸獵鹽選壓積, 憲繭衊糧衊蓋壓範襯憲 ~ 窪襯網遞觸鹽獵窪淵醖) 更多	-	2023-10-23
				TRK-250 (PartA:TRK-250 10mg)	繭鑰製餘顧鬱製鹹憲襯(膚廠積積鏇鹽齋淵遞簾) = 選餘遞簾觸齋顧顧窪齋齋壓構餘繭遞艱淵衊壓 (膚網遞鹽觸獵鹽選壓積, 齋窪範製遞顧積餘選齋 ~ 鑰膚鑰鬱膚獵廠築夢築) 更多