Healthy VolunteersPhase 1NCT04964258
A Study of TAK-105 in Healthy Adults
A Phase 1 study testing TAK-105-a in people with Healthy Volunteers, run by Takeda at 3 sites in United States.
Trial summary
It is hoped that in the future, TAK-105 will be used to help treat people with nausea and vomiting. The main aims of this study are as follows: To check for side effects from TAK-105 in healthy adults. To learn how much TAK-105 they can receive without getting side effects from it. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TAK-105-a
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Jul 2021to 20 Jun 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For All Cohorts
- Must have a body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to (<=) 30.0 kilogram per square meter (kg/m^2).
- Continuous nonsmoker who has not used nicotine and tobacco-containing products for at least 3 months prior to screening and through discharge.
- Be judged to be in good health (example, no evidence of psychiatric, hepatic, renal, pulmonary, or cardiovascular disease) by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, electrocardiogram (ECG), and vital sign measurements performed at the screening visit and before administration of the initial dose of study drug or invasive procedure.
- For Japanese participants in Part 5 (Cohorts 28 to 32 only):
- Has 2 Japanese parents and 4 Japanese grandparents, as confirmed by interview.
Who cannot join
- Participated in another investigational study within 4 weeks (or based on local regulations) or within 5 half-lives of the investigational product before the screening visit. The 4-week or 5 half-lives window will be derived from the date of the last dose and/or adverse event (AE) related to the study procedure in the previous study to the screening visit of the current study.
- Has a history of significant multiple and/or severe allergies (example, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.
- Has a known hypersensitivity or contraindication to any component of TAK 105.
- Has positive pregnancy test or is lactating or breastfeeding.
- Has known or suspected current coronavirus disease 2019 (COVID-19) infection or is at risk of COVID-19 infection as assessed by the investigator.
- Unable to refrain from or anticipates using all medications including herbal medicines beginning approximately 7 days before administration of the first dose of study drug, throughout the study until the last follow-up visit.
Show all 18Show fewer
- With history or presence of:
- 3 or more incidences of syncope (example, vasovagal) within the last 5 years prior to screening;
- A family history of unexplained sudden death or channelopathy;
- Brugada syndrome (RBBB [right bundle branch block] pattern with ST-elevation in leads V1 V3);
- CV or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, sick sinus syndrome, pulmonary congestion, symptomatic or significant cardiac arrhythmia, supraventricular or ventricular tachycardia, second-degree atrioventricular (AV) block type 2, third degree AV block, prolonged QT interval with Fridericia correction method (QTcF) interval, hypokalemia, hypomagnesemia, or conduction abnormalities;
- Risk factors for Torsade de Pointes (example, heart failure, cardiomyopathy, or family history of Long QT Syndrome);
- Any clinically significant ECG findings or medical history including: long or short QTcF (over 450 milli second [msec] or less than 360 msec), bifascicular block or QRS greater than equal to (>=)120 msec or PR interval > 200 msec at screening or Day 1 pre-Hour 0;
- Has a documented history of sinus bradycardia less than (<) 45 beats per minute [bpm]) based upon vital signs assessments, sinoatrial block as evidenced on ECG or sinus pause >=3 seconds on ECG or predose telemetry.
- Has an average semi recumbent blood pressure (BP) less than 90 (systolic) and 60 (diastolic) millimeter of mercury (mmHg) or greater than 140/90 mmHg from screening to predose, inclusive.
- From screening to Day -2, participants with an average semirecumbent heart rate (HR) <55 or >100 beats per minute (bpm) should be excluded. From Day -2 to predose, enrollment of participants with an average HR <55 or >100 bpm will be left to the judgment of the investigator, unless HR is <50 bpm, which must be discussed with the medical monitor for approval.
- Has orthostatic hypotension defined as a decrease in systolic BP (SBP) >=20 mmHg or a decrease in diastolic BP (DPB) >=10 mmHg at approximately 2 minutes of standing when compared with BP from the semirecumbent position at screening to predose assessments, inclusive.
- Has postural orthostatic tachycardia, defined as an increase of >30 bpm or HR >120 bpm at approximately 2 minutes of standing, at screening to predose assessments, inclusive.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
PPD Development, LP
Austin, Texas, 78744
PPD Development, LP
Las Vegas, Nevada, 89113
Celerion
Tempe, Arizona, 85283
About this study
Official title: A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-105 in Healthy Subjects
It is hoped that in the future, TAK-105 will be used to help treat people with nausea and vomiting. The main aims of this study are as follows:
- To check for side effects from TAK-105 in healthy adults.
- To learn how much TAK-105 they can receive without getting side effects from it.
Read more
Participants will receive either TAK-105 as TAK-105-a or TAK-105-b (depending upon the part they are enrolled in) or a placebo as an injection under the skin (sub-cutaneous injection). A placebo looks like TAK-105-a or TAK-105-b but will not have any medicine in it. Three times as many participants will receive TAK-105-a or TAK-105-b than placebo.
The study will have 6 parts. Each part will have several small groups of participants, called cohorts. Participants will only be in 1 cohort in 1 part of the study.
Part 1: Participants will check into the study clinic to receive a single dose of TAK-105-a or placebo and will stay in the clinic for about 10 days. Then, participants return to the clinic for follow-up visits up to about 60 days after the dose.
Part 2: Participants will check into the study clinic to receive TAK-105-a or placebo once a week for 4 weeks, and will stay in the clinic for about 26 days. Then, participants return to the clinic for follow-up visits up to about 60 days after last dose.
Part 3: Participants will check into the study clinic to receive 2, 3 or 4 weekly doses of TAK-105-a or placebo. Their clinic stay will be for 10 to 24 days depending which cohort they are in. Then, participants return to the clinic for follow-up visits up to about 28 days after last dose.
Part 4: Participants will check into the study clinic to receive 2 doses (once a week for 2 weeks) of TAK-105-a or placebo and will stay in the study clinic for about 12 days. They will return to the clinic later (in about 1-3 weeks) for another (third) dose and will stay for 2 days after the third dose. Then, participants return to the clinic for follow-up visits up to about 3 months after first dose.
Part 5a: Participants will check into the study clinic to receive a single dose of TAK-105-a or placebo and will stay in the clinic for about 10 days. Then, participants return to the clinic for follow-up visits up to about 60 days after the dose.
Part 5b: Participants will check into the study clinic to receive TAK-105-a or placebo once a week for 4 weeks, and will stay in the clinic for about 26 days. Then, participants return to the clinic for follow-up visits up to about 60 days after last dose. Part 5b will be optional, depending on the pharmacokinetic (PK) and safety data observed in Part 2.
Part 6: Participants will check into the study clinic to receive a single dose of TAK-105-b or placebo and will stay in the clinic for about 10 days. Then, participants return to the clinic for follow-up visits up to about 60 days after the dose.
Read the detailed description
The drug being tested in this study is called TAK-105. The study will look at the safety, tolerability, and PK of TAK-105-a and TAK-105-b in healthy participants.
Participants in each cohort will be randomized to receive treatment with TAK-105-a or TAK-105-b or matching placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). The study consists of 6 parts and up to 34 cohorts as mentioned below:
- Part 1 (SRD) will enroll healthy participants in up to 12 cohorts.
- Part 2 (MRD) will enroll healthy participants in up to 5 ascending cohorts.
- Part 3 (Dose titration) will enroll healthy participants in up to 6 multiple-dose cohorts.
- Part 4 (Redosing) will enroll healthy participants in up to 4 redosing cohorts.
- Part 5a (SRD) will enroll healthy Japanese participants in up to 3 cohorts.
- Part 5b (MRD) (optional) will enroll healthy Japanese participants in up to 2 cohorts. The MRD cohorts in Part 5b will be optional, depending on the PK and safety data observed in Part 2 (MRD).
- Part 6 (SRD) will enroll healthy participants in up to 2 cohorts.
Each cohort in all the parts will have 8 randomized participants with 6 participants receiving a single dose of TAK-105-a in Parts 1 to 5 or TAK-105-b in Part 6, and 2 receiving TAK-105-a matching placebo (Parts 1 to 5) or TAK-105-b matching placebo (Part 6) in a 3:1 ratio. This multi-center trial will be conducted in the United States. The overall duration of the study is approximately 18 months.
- Conditions
- Healthy Volunteers
- Being tested
- TAK-105-a, TAK-105-a Placebo
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-105-aDrug
TAK-105-a subcutaneous solution.
TAK-105-a PlaceboDrug
TAK-105-a placebo-matching solution.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Placebo | Placebo comparator | TAK-105-a matching-placebo, injection, subcutaneously, once on Day 1. Receives: Drug: TAK-105-a Placebo |
| Part 1: TAK-105 Dose 1 | Experimental | TAK-105-a Dose 1, injection, subcutaneously, once on Day 1. Receives: Drug: TAK-105-a |
| Part 1: TAK-105 Dose 2 | Experimental | TAK-105-a Dose 2, injection, subcutaneously, once on Day 1. Receives: Drug: TAK-105-a |
| Part 1: TAK-105 Dose 3 | Experimental | TAK-105-a Dose 3, injection, subcutaneously, once on Day 1. Receives: Drug: TAK-105-a |
| Part 1: TAK-105 Dose 4 | Experimental | TAK-105-a Dose 4, injection, subcutaneously, once on Day 1. Receives: Drug: TAK-105-a |
| Part 1: TAK-105 Dose 5 | Experimental | TAK-105-a Dose 5, injection, subcutaneously, once on Day 1. Receives: Drug: TAK-105-a |
| Part 1: TAK-105 Dose 6 | Experimental | TAK-105-a Dose 6, injection, subcutaneously, once on Day 1. Receives: Drug: TAK-105-a |
| Part 1: TAK-105 Dose 7 | Experimental | TAK-105-a Dose 7, injection, subcutaneously, once on Day 1. Receives: Drug: TAK-105-a |
| Part 2: Placebo | Placebo comparator | TAK-105-a matching-placebo, injection, subcutaneously, once weekly for 4 weeks. Receives: Drug: TAK-105-a Placebo |
| Part 2: TAK-105 Dose 1A | Experimental | TAK-105-a Dose 1A, injection, subcutaneously, once weekly for up to 4 weeks. Receives: Drug: TAK-105-a |
| Part 2: TAK-105 Dose 2A | Experimental | TAK-105-a Dose 2A, injection, subcutaneously, once weekly for 1 week. Receives: Drug: TAK-105-a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With At Least One Treatment-emergent Adverse Event (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE that started or worsened after the first dose of the study treatment and last dose of study treatment.
Measured: Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
Secondary outcomes (1)
Number of Participants Based on Antidrug Antibody (ADA) Status
ADA included ADA-negative or transiently and persistently ADA-positive, and low or high ADA titer assessment. ADA negative was defined as participants who did not have a confirmed positive ADA status in any postbaseline assessment. Transiently ADA positive was defined as participants who had confirmed positive ADA status in 1 or 2 postbaseline assessments. Persistently ADA positive was defined as participants who had confirmed positive ADA status in more than 2 postbaseline assessments. For ADA positive (transiently ADA positive or persistently ADA positive) only, high ADA titer was defined as participant who has at least 1 postbaseline ADA titer greater than (>) 16; low ADA titer was defined as participant whose postbaseline ADA titers were all less than or equal to (<=) 16. ADA titer was assessed in ADA-positive participants.
Measured: Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start26 Jul 2021
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964258
- Sponsor's protocol ID
- TAK-105-1001
- Status last verified
- Feb 2024
- First submitted
- 7 Jul 2021
- Last updated
- 2 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-105 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04964258
- Acronym / sponsor ID
- TAK-105-1001
- Conditions
- Healthy Volunteers
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Posted 2 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is hoped that in the future, TAK-105 will be used to help treat people with nausea and vomiting. The main aims of this study are as follows:
- To check for side effects from TAK-105 in healthy adults.
- To learn how much TAK-105 they can receive without getting side effects from it.
Participants will receive either TAK-105 as TAK-105-a or TAK-105-b (depending upon the part they are enrolled in) or a placebo as an injection under the skin (sub-cutaneous injection). A placebo looks like TAK-105-a or TAK-105-b but will not have any medicine in it. Three times as many participants will receive TAK-105-a or TAK-105-b than placebo.
The study will have 6 parts. Each part will have several small groups of participants, called cohorts. Participants will only be in 1 cohort in 1 part of the study.
Part 1: Participants will check into the study clinic to receive a single dose of TAK-105-a or placebo and will stay in the clinic for about 10 days. Then, participants return to the clinic for follow-up visits up to about 60 days after the dose.
Part 2: Participants will check into the study clinic to receive TAK-105-a or placebo once a week for 4 weeks, and will stay in the clinic for about 26 days. Then, participants return to the clinic for follow-up visits up to about 60 days after last dose.
Part 3: Participants will check into the study clinic to receive 2, 3 or 4 weekly doses of TAK-105-a or placebo. Their clinic stay will be for 10 to 24 days depending which cohort they are in. Then, participants return to the clinic for follow-up visits up to about 28 days after last dose.
Part 4: Participants will check into the study clinic to receive 2 doses (once a week for 2 weeks) of TAK-105-a or placebo and will stay in the study clinic for about 12 days. They will return to the clinic later (in about 1-3 weeks) for another (third) dose and will stay for 2 days after the third dose. Then, participants return to the clinic for follow-up visits up to about 3 months after first dose.
Part 5a: Participants will check into the study clinic to receive a single dose of TAK-105-a or placebo and will stay in the clinic for about 10 days. Then, participants return to the clinic for follow-up visits up to about 60 days after the dose.
Part 5b: Participants will check into the study clinic to receive TAK-105-a or placebo once a week for 4 weeks, and will stay in the clinic for about 26 days. Then, participants return to the clinic for follow-up visits up to about 60 days after last dose. Part 5b will be optional, depending on the pharmacokinetic (PK) and safety data observed in Part 2.
Part 6: Participants will check into the study clinic to receive a single dose of TAK-105-b or placebo and will stay in the clinic for about 10 days. Then, participants return to the clinic for follow-up visits up to about 60 days after the dose.
Detailed description
The drug being tested in this study is called TAK-105. The study will look at the safety, tolerability, and PK of TAK-105-a and TAK-105-b in healthy participants.
Participants in each cohort will be randomized to receive treatment with TAK-105-a or TAK-105-b or matching placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). The study consists of 6 parts and up to 34 cohorts as mentioned below:
- Part 1 (SRD) will enroll healthy participants in up to 12 cohorts.
- Part 2 (MRD) will enroll healthy participants in up to 5 ascending cohorts.
- Part 3 (Dose titration) will enroll healthy participants in up to 6 multiple-dose cohorts.
- Part 4 (Redosing) will enroll healthy participants in up to 4 redosing cohorts.
- Part 5a (SRD) will enroll healthy Japanese participants in up to 3 cohorts.
- Part 5b (MRD) (optional) will enroll healthy Japanese participants in up to 2 cohorts. The MRD cohorts in Part 5b will be optional, depending on the PK and safety data observed in Part 2 (MRD).
- Part 6 (SRD) will enroll healthy participants in up to 2 cohorts.
Each cohort in all the parts will have 8 randomized participants with 6 participants receiving a single dose of TAK-105-a in Parts 1 to 5 or TAK-105-b in Part 6, and 2 receiving TAK-105-a matching placebo (Parts 1 to 5) or TAK-105-b matching placebo (Part 6) in a 3:1 ratio. This multi-center trial will be conducted in the United States. The overall duration of the study is approximately 18 months.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part 1: Placebo | Placebo comparator | Drug: TAK-105-a PlaceboTAK-105-a matching-placebo, injection, subcutaneously, once on Day 1. |
| Part 1: TAK-105 Dose 1 | Experimental | Drug: TAK-105-aTAK-105-a Dose 1, injection, subcutaneously, once on Day 1. |
| Part 1: TAK-105 Dose 2 | Experimental | Drug: TAK-105-aTAK-105-a Dose 2, injection, subcutaneously, once on Day 1. |
| Part 1: TAK-105 Dose 3 | Experimental | Drug: TAK-105-aTAK-105-a Dose 3, injection, subcutaneously, once on Day 1. |
| Part 1: TAK-105 Dose 4 | Experimental | Drug: TAK-105-aTAK-105-a Dose 4, injection, subcutaneously, once on Day 1. |
| Part 1: TAK-105 Dose 5 | Experimental | Drug: TAK-105-aTAK-105-a Dose 5, injection, subcutaneously, once on Day 1. |
| Part 1: TAK-105 Dose 6 | Experimental | Drug: TAK-105-aTAK-105-a Dose 6, injection, subcutaneously, once on Day 1. |
| Part 1: TAK-105 Dose 7 | Experimental | Drug: TAK-105-aTAK-105-a Dose 7, injection, subcutaneously, once on Day 1. |
| Part 2: Placebo | Placebo comparator | Drug: TAK-105-a PlaceboTAK-105-a matching-placebo, injection, subcutaneously, once weekly for 4 weeks. |
| Part 2: TAK-105 Dose 1A | Experimental | Drug: TAK-105-aTAK-105-a Dose 1A, injection, subcutaneously, once weekly for up to 4 weeks. |
| Part 2: TAK-105 Dose 2A | Experimental | Drug: TAK-105-aTAK-105-a Dose 2A, injection, subcutaneously, once weekly for 1 week. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- For All Cohorts
- Must have a body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to (<=) 30.0 kilogram per square meter (kg/m^2).
- Continuous nonsmoker who has not used nicotine and tobacco-containing products for at least 3 months prior to screening and through discharge.
- Be judged to be in good health (example, no evidence of psychiatric, hepatic, renal, pulmonary, or cardiovascular disease) by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, electrocardiogram (ECG), and vital sign measurements performed at the screening visit and before administration of the initial dose of study drug or invasive procedure.
- Has 2 Japanese parents and 4 Japanese grandparents, as confirmed by interview.
Key exclusion criteria (18 listed)
- Participated in another investigational study within 4 weeks (or based on local regulations) or within 5 half-lives of the investigational product before the screening visit. The 4-week or 5 half-lives window will be derived from the date of the last dose and/or adverse event (AE) related to the study procedure in the previous study to the screening visit of the current study.
- Has a history of significant multiple and/or severe allergies (example, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.
- Has a known hypersensitivity or contraindication to any component of TAK 105.
- Has positive pregnancy test or is lactating or breastfeeding.
- Has known or suspected current coronavirus disease 2019 (COVID-19) infection or is at risk of COVID-19 infection as assessed by the investigator.
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 |
|---|---|---|
| TAK-105-aTAK-105-a subcutaneous solution. | Drug | Part 1: TAK-105 Dose 1, Part 1: TAK-105 Dose 2, Part 1: TAK-105 Dose 3, Part 1: TAK-105 Dose 4, Part 1: TAK-105 Dose 5, Part 1: TAK-105 Dose 6, Part 1: TAK-105 Dose 7, Part 2: TAK-105 Dose 1A, Part 2: TAK-105 Dose 2A |
| TAK-105-a PlaceboTAK-105-a placebo-matching solution. | Drug | Part 1: Placebo, Part 2: Placebo |
Primary outcome
Number of Participants With At Least One Treatment-emergent Adverse Event (TEAEs)
Time frame: Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE that started or worsened after the first dose of the study treatment and last dose of study treatment.
1 secondary outcome
Number of Participants Based on Antidrug Antibody (ADA) Status
Time frame: Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain more information on the study, click on this link.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Study Director study director
Takeda
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-105-a in people with Healthy Volunteers, run by Takeda at 3 sites in United States.
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 18 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 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 2 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With At Least One Treatment-emergent Adverse Event (TEAEs) (time frame: Part 1: Baseline up to Day 60; Part 2: Baseline up to Day 82). 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 Aug 2024.