Healthy VolunteerPhase 1NCT05018533
The Safety and Pharmacokinetics Study of TAKC-02 Inhalation Solution in Healthy Adult Males.
A Phase 1 study testing TAKC-02 in people with Healthy Volunteer, run by TAK-Circulator Co. at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- TAKC-02
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteJapan
- Study dates
- 17 Aug 2021to 28 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Healthy Volunteer
- Being tested
- TAKC-02, Placebo
- Keywords
- antisense oligonucleotides, anti asthmatic agents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAKC-02Drug
Inhalation Solution
PlaceboDrug
Inhalation Solution
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | TAKC-02 0.15mg Single dose Receives: Drug: TAKC-02 |
| Placebo (to Cohort 1) | Placebo comparator | Not described Receives: Drug: Placebo |
| Cohort 2 | Experimental | TAKC-02 0.5mg Single dose Receives: Drug: TAKC-02 |
| Placebo (to Cohort 2) | Placebo comparator | Not described Receives: Drug: Placebo |
| Cohort 3 | Experimental | TAKC-02 1.5mg Single dose Receives: Drug: TAKC-02 |
| Placebo (to Cohort 3) | Placebo comparator | Not described Receives: Drug: Placebo |
| Cohort 4 | Experimental | TAKC-02 5mg Single dose Receives: Drug: TAKC-02 |
| Placebo (to Cohort 4) | Placebo comparator | Not described Receives: Drug: Placebo |
| Cohort 5 | Experimental | TAKC-02 15mg Single dose Receives: Drug: TAKC-02 |
| Placebo (to Cohort 5) | Placebo comparator | Not described Receives: Drug: Placebo |
| Cohort 6 | Experimental | TAKC-02 Multiple dose (low) Receives: Drug: TAKC-02 |
| Placebo (to Cohort 6) | Placebo comparator | Not described Receives: Drug: Placebo |
| Cohort 7 | Experimental | TAKC-02 Multiple dose (high) Receives: Drug: TAKC-02 |
| Placebo (to Cohort 7) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the rate of adverse events
assessed by the change in number of adverse events
Measured: Up to 7 days after dose
Secondary outcomes (4)
AUC from time zero to the time of the last quantifiable concentration (AUC0-t last)
Measured: Up to 48 hours after last dose
Cmax
Measured: Up to 48 hours after last dose
Tmax
Measured: Up to 48 hours after last dose
T1/2
Measured: Up to 48 hours after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start17 Aug 2021
- Primary completion28 Dec 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- TAK-Circulator Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018533
- Sponsor's protocol ID
- TAKC-02-001
- Status last verified
- May 2022
- First submitted
- 17 Aug 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Pharmacokinetics Study of TAKC-02 Inhalation Solution in Healthy Adult Males.
- ClinicalTrials.gov ID
- NCT05018533
- Acronym / sponsor ID
- TAKC-02-001
- Conditions
- Healthy Volunteer
- Keywords
- antisense oligonucleotides, anti asthmatic agents
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- TAK-Circulator Co.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 28 Dec 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: TAKC-02TAKC-02 0.15mg Single dose |
| Placebo (to Cohort 1) | Placebo comparator | Drug: Placebo |
| Cohort 2 | Experimental | Drug: TAKC-02TAKC-02 0.5mg Single dose |
| Placebo (to Cohort 2) | Placebo comparator | Drug: Placebo |
| Cohort 3 | Experimental | Drug: TAKC-02TAKC-02 1.5mg Single dose |
| Placebo (to Cohort 3) | Placebo comparator | Drug: Placebo |
| Cohort 4 | Experimental | Drug: TAKC-02TAKC-02 5mg Single dose |
| Placebo (to Cohort 4) | Placebo comparator | Drug: Placebo |
| Cohort 5 | Experimental | Drug: TAKC-02TAKC-02 15mg Single dose |
| Placebo (to Cohort 5) | Placebo comparator | Drug: Placebo |
| Cohort 6 | Experimental | Drug: TAKC-02TAKC-02 Multiple dose (low) |
| Placebo (to Cohort 6) | Placebo comparator | Drug: Placebo |
| Cohort 7 | Experimental | Drug: TAKC-02TAKC-02 Multiple dose (high) |
| Placebo (to Cohort 7) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Both Step 1 and Step 2 are for healthy adult males who meet all of the following conditions.
Key exclusion criteria (19 listed)
- Both Step 1 and Step 2 do not apply to those who meet any of the following conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAKC-02Inhalation Solution | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7 |
| PlaceboInhalation Solution | Drug | 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) |
Primary outcome
Changes in the rate of adverse events
Time frame: Up to 7 days after dose
assessed by the change in number of adverse events
4 secondary outcomes
AUC from time zero to the time of the last quantifiable concentration (AUC0-t last)
Time frame: Up to 48 hours after last dose
Cmax
Time frame: Up to 48 hours after last dose
Tmax
Time frame: Up to 48 hours after last dose
T1/2
Time frame: Up to 48 hours after last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAKC-02 in people with Healthy Volunteer, run by TAK-Circulator Co. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the rate of adverse events (time frame: Up to 7 days after dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.