The Safety and Pharmacokinetics Study of TAKC-02 Inhalation Solution in Healthy Adult Males.
Status:
Recruiting
Trial end date:
2022-03-31
Target enrollment:
Participant gender:
Summary
MEX3B is an RNA-binding protein that is conserved in many animal species and has wide range
of biological function. The MEX3B protein is deeply involved in the expression of various
cytokines associated with the onset and exacerbation of several diseases such as inflammatory
diseases, metabolic diseases, and malignant tumors. TAKC-02 is a nucleic acid medicine,
antisense oligonucleotide, inhibits the MEX3B synthesis expected to have potential as new
medication.
This plans to evaluate the safety profile of the inhalation solution in order to develop
TAKC-02 for severe asthma.
The 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 TAKC-02 in healthy male subjects. The study is a Single Ascending Dose (Step
1) followed by a Multiple Comparative Dose (Step 2).