Back to resultsThe Safety and Pharmacokinetics Study of TAKC-02 Inhalation Solution in Healthy Adult Males.
Primary Purpose
Healthy Volunteer
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
TAKC-02
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Healthy Volunteer focused on measuring antisense oligonucleotides, anti asthmatic agents
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
- Subjects participated in another clinical trial and were administered anther test drug within 16 weeks before the administration of the study drug, or those who participated in another clinical trial at the same time as this clinical trial.
- Subjects have been vaccinated against new coronavirus, influenza, etc. within 4 weeks before the administration of the study drug, or who are scheduled to be vaccinated during the period of participation in the study.
- Subjects are not willing to adhere to proper contraception using effective contraception for 3 weeks after the last dose of the study drug from the date of admission of study site.
- Subjects are judged inappropriate to participate in the clinical trial by the investigator or the co-investigator.
Sites / Locations
- TAKC-02 Study Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Cohort 1
Placebo (to Cohort 1)
Cohort 2
Placebo (to Cohort 2)
Cohort 3
Placebo (to Cohort 3)
Cohort 4
Placebo (to Cohort 4)
Cohort 5
Placebo (to Cohort 5)
Cohort 6
Placebo (to Cohort 6)
Cohort 7
Placebo (to Cohort 7)
Arm Description
TAKC-02 0.15mg Single dose
TAKC-02 0.5mg Single dose
TAKC-02 1.5mg Single dose
TAKC-02 5mg Single dose
TAKC-02 15mg Single dose
TAKC-02 Multiple dose (low)
TAKC-02 Multiple dose (high)
Outcomes
Primary Outcome Measures
Changes in the rate of adverse events
assessed by the change in number of adverse events
Secondary Outcome Measures
AUC from time zero to the time of the last quantifiable concentration (AUC0-t last)
Cmax
Tmax
T1/2
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05018533
Brief Title
The Safety and Pharmacokinetics Study of TAKC-02 Inhalation Solution in Healthy Adult Males.
Official Title
The Safety and Pharmacokinetics Study of TAKC-02 Inhalation Solution in Healthy Adult Males.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 17, 2021 (Actual)
Primary Completion Date
December 28, 2021 (Actual)
Study Completion Date
December 28, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TAK-Circulator Co.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
Detailed Description
This initial Phase I study will be conducted in normal healthy male volunteers to obtain an unconfounded understanding of the safety, tolerability and pharmacokinetics of TAKC-02 inhalation solution. TAKC-02 is being developed as a medication for uncontrolled severe asthma. The first-in-human, randomized, double-blind trial will evaluate single ascending doses (SAD) and subsequently multiple ascending doses (MAD) of TAKC-02 and placebo.
Step 1 (SAD) :
There will be 5 cohort of 6 (Cohort 1, 2, 3) or 8 (Cohort 4, 5) subjects each. Subjects in each cohort are randomized in a 2:1 ratio (Cohort 1, 2, 3) and 3:1 ratio to receive a single dose of the study drugs, TAKC-02 or Placebo. The SAD study will evaluate the safety and tolerability of a single dose of TAKC-02 and determine the starting and maximum doses for Step 2. Pharmacokinetics will be also analyzed. One cohort (cohort 4.5) maybe added depending on the incidence of adverse effect in the lower dosing group.
Step 2 There will be 2 cohort f 8 subjects each. Subjects in both cohorts are randomized in a 3:1 ratio to receive multiple doses of the study drugs, TAKC-02 or Placebo. The safety and tolerability of repeated administration of TAKC-02 for 2 weeks will be evaluated, and the maximum dose of this drug in the next phase will be estimated. Pharmacokinetics will be also analyzed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteer
Keywords
antisense oligonucleotides, anti asthmatic agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Not applicable to a drug allotment and a dispensing staff
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
TAKC-02 0.15mg Single dose
Arm Title
Placebo (to Cohort 1)
Arm Type
Placebo Comparator
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
TAKC-02 0.5mg Single dose
Arm Title
Placebo (to Cohort 2)
Arm Type
Placebo Comparator
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
TAKC-02 1.5mg Single dose
Arm Title
Placebo (to Cohort 3)
Arm Type
Placebo Comparator
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
TAKC-02 5mg Single dose
Arm Title
Placebo (to Cohort 4)
Arm Type
Placebo Comparator
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
TAKC-02 15mg Single dose
Arm Title
Placebo (to Cohort 5)
Arm Type
Placebo Comparator
Arm Title
Cohort 6
Arm Type
Experimental
Arm Description
TAKC-02 Multiple dose (low)
Arm Title
Placebo (to Cohort 6)
Arm Type
Placebo Comparator
Arm Title
Cohort 7
Arm Type
Experimental
Arm Description
TAKC-02 Multiple dose (high)
Arm Title
Placebo (to Cohort 7)
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TAKC-02
Intervention Description
Inhalation Solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inhalation Solution
Primary Outcome Measure Information:
Title
Changes in the rate of adverse events
Description
assessed by the change in number of adverse events
Time Frame
Up to 7 days after dose
Secondary Outcome Measure Information:
Title
AUC from time zero to the time of the last quantifiable concentration (AUC0-t last)
Time Frame
Up to 48 hours after last dose
Title
Cmax
Time Frame
Up to 48 hours after last dose
Title
Tmax
Time Frame
Up to 48 hours after last dose
Title
T1/2
Time Frame
Up to 48 hours after last dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Subjects participated in another clinical trial and were administered anther test drug within 16 weeks before the administration of the study drug, or those who participated in another clinical trial at the same time as this clinical trial.
Subjects have been vaccinated against new coronavirus, influenza, etc. within 4 weeks before the administration of the study drug, or who are scheduled to be vaccinated during the period of participation in the study.
Subjects are not willing to adhere to proper contraception using effective contraception for 3 weeks after the last dose of the study drug from the date of admission of study site.
Subjects are judged inappropriate to participate in the clinical trial by the investigator or the co-investigator.
Facility Information:
Facility Name
TAKC-02 Study Site
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
The Safety and Pharmacokinetics Study of TAKC-02 Inhalation Solution in Healthy Adult Males.
We'll reach out to this number within 24 hrs