The Safety and Pharmacokinetics Study of TAKC-02 Inhalation Solution in Healthy Adult Males.

NCT05018533 | Completed Phase 1

• 1 other identifier: TAKC-02-001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy Volunteer

Keywords

antisense oligonucleotides; anti asthmatic agents

Outcome Measures

Primary Outcomes (1)

• Changes in the rate of adverse events

  assessed by the change in number of adverse events

  Up to 7 days after dose

Secondary Outcomes (4)

• AUC from time zero to the time of the last quantifiable concentration (AUC0-t last)

  Up to 48 hours after last dose

• Cmax

  Up to 48 hours after last dose

• Tmax

  Up to 48 hours after last dose

• T1/2

  Up to 48 hours after last dose

Study Arms (14)

Cohort 1

EXPERIMENTAL

TAKC-02 0.15mg Single dose

Drug: TAKC-02

Placebo (to Cohort 1)

PLACEBO COMPARATOR

Drug: Placebo

Cohort 2

EXPERIMENTAL

TAKC-02 0.5mg Single dose

Drug: TAKC-02

Placebo (to Cohort 2)

PLACEBO COMPARATOR

Drug: Placebo

Cohort 3

EXPERIMENTAL

TAKC-02 1.5mg Single dose

Drug: TAKC-02

Placebo (to Cohort 3)

PLACEBO COMPARATOR

Drug: Placebo

Cohort 4

EXPERIMENTAL

TAKC-02 5mg Single dose

Drug: TAKC-02

Placebo (to Cohort 4)

PLACEBO COMPARATOR

Drug: Placebo

Cohort 5

EXPERIMENTAL

TAKC-02 15mg Single dose

Drug: TAKC-02

Placebo (to Cohort 5)

PLACEBO COMPARATOR

Drug: Placebo

Cohort 6

EXPERIMENTAL

TAKC-02 Multiple dose (low)

Drug: TAKC-02

Placebo (to Cohort 6)

PLACEBO COMPARATOR

Drug: Placebo

Cohort 7

EXPERIMENTAL

TAKC-02 Multiple dose (high)

Drug: TAKC-02

Placebo (to Cohort 7)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TAKC-02 DRUG

Inhalation Solution

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7

Placebo DRUG

Inhalation Solution

Placebo (to Cohort 1); Placebo (to Cohort 2); Placebo (to Cohort 3); Placebo (to Cohort 4); Placebo (to Cohort 5); Placebo (to Cohort 6); Placebo (to Cohort 7)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Both Step 1 and Step 2 are for healthy adult males who meet all of the following conditions.
• Subjects are normal healthy men
• Aged between 20 and 40 at the time of consent
• Subjects who have obtained the voluntary consent of the person in writing
• Subjects with BMI of 18.5 or more and less than 25.0 kg / m2
• Subjects who can be hospitalized during the cohort transition safety assessment period

You may not qualify if:

• Both Step 1 and Step 2 do not apply to those who meet any of the following conditions.
• Subjects with clinically problematic complications or medical history
• Subjects with a history of drug allergies
• Smokers (those who have smoked within 1 year)
• Subjects with hypersensitivity disease (excluding asymptomatic pollinosis)
• Those who may affect the absorption, distribution, metabolism and excretion of drugs
• Subjects have been prescribed a drug intended for treatment within 4 weeks before administration of the study drug, or those who need administration during the period of participation in the study
• Subjects have used over-the-counter drugs within 4 weeks before administration of the study drug, or those who need to use it during the period of participation in the study
• Subjects ingested alcoholic beverages or caffeine-containing beverages within 24 hours before administration of the study drug
• Subjects with reduced lung function (FEV1.0% \<70%)
• Subjects with alcoholism or drug addiction
• Subjects have a positive reaction in the substance abuse test
• Subjects tested positive for HBsAg, hepatitis C virus (HCV) antibody, HIV antigen / antibody, syphilis serum reaction or severe acute respiratory syndrome (SARS)-CoV-2 nucleic acid amplification
• Subjects collected 400 mL or more of whole blood within 16 weeks before administration of the study drug or 200 mL or more of blood within 4 weeks, or those who collected component blood (plasma component and platelet component) within 2 weeks before administration of the study drug, or subjects whose annual total blood collection volume exceeds 1200 mL, including the planned blood collection volume for clinical trials
• Subjects have been treated with TAKC-02 in the past

Sponsors & Collaborators

• TAK-Circulator Co.: lead

Study Sites (1)

TAKC-02 Study Site

Tokyo, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Not applicable to a drug allotment and a dispensing staff
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 24, 2021
• Study Start: August 17, 2021
• Primary Completion: December 28, 2021
• Study Completion: December 28, 2021
• Last Updated: June 2, 2022

Record last verified: 2022-05

Locations

JP (1)