Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04731922
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2021-01-27
Brief Title:
A Study of TAK-510 in Healthy Adults
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase 1 Study to Evaluate the Safety Tolerability and Pharmacokinetics of TAK-510 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study of TAK-510 for people with symptoms of feeling sick nausea or being sick vomiting
The main aims of the study are to check if healthy adults have side effects from TAK-510 and to check how much TAK-510 they can receive without getting side effects from it
The study will be in 3 parts Participants will take part in only 1 of the 3 parts of the study
At the first visit the study doctor will check if each person can take part For those who can take part they will be placed in 1 of many small groups The 1st groups will join Part 1 of the study the 2nd groups will join Part 2 and the 3rd groups will join Part 3 They will receive an injection under the skin of either TAK-510 or placebo In this study a placebo will look like the TAK-510 injection but will not have any medicine in it
In Part 1 the 1st group of participants will receive 1 injection of either TAK-510 or placebo Different participants within this group will receive lower to higher doses of TAK-510 The participants in this group will stay in the clinic for 4 days after their injection for some tests and check for any side effects from their treatment
In Part 2 the 2nd group of participants will receive an injection of either TAK-510 or placebo once a day for 5 days Different participants within this group will receive lower to higher doses of TAK-510 The participants in this group will stay in the clinic for 9 days after their 1st injection for some tests and check for any side effects from their treatment
In Part 3 the 3rd group of participants will visit the clinic 2 times At the 1st visit they will receive an injection either of TAK-510 or placebo once a day for 7 days Each participant in this group will receive lower to higher doses of TAK-510 They will stay in the clinic for 8 days after their 1st injection for some tests and check for any side effects from their treatment
At the 2nd clinic visit each participant will receive 1 single injection of TAK-510 or placebo This will happen 7 days after their last injection from the previous clinic visit They will receive the same dose as their previous dose They will stay in the clinic for 3 days for some tests and check for any side effects from their treatment
After treatment all participants in the study will return to the clinic for a weekly check-up visit for up to 3 weeks
The main aims of the study are to check if healthy adults have side effects from TAK-510 and to check how much TAK-510 they can receive without getting side effects from it
The study will be in 3 parts Participants will take part in only 1 of the 3 parts of the study
At the first visit the study doctor will check if each person can take part For those who can take part they will be placed in 1 of many small groups The 1st groups will join Part 1 of the study the 2nd groups will join Part 2 and the 3rd groups will join Part 3 They will receive an injection under the skin of either TAK-510 or placebo In this study a placebo will look like the TAK-510 injection but will not have any medicine in it
In Part 1 the 1st group of participants will receive 1 injection of either TAK-510 or placebo Different participants within this group will receive lower to higher doses of TAK-510 The participants in this group will stay in the clinic for 4 days after their injection for some tests and check for any side effects from their treatment
In Part 2 the 2nd group of participants will receive an injection of either TAK-510 or placebo once a day for 5 days Different participants within this group will receive lower to higher doses of TAK-510 The participants in this group will stay in the clinic for 9 days after their 1st injection for some tests and check for any side effects from their treatment
In Part 3 the 3rd group of participants will visit the clinic 2 times At the 1st visit they will receive an injection either of TAK-510 or placebo once a day for 7 days Each participant in this group will receive lower to higher doses of TAK-510 They will stay in the clinic for 8 days after their 1st injection for some tests and check for any side effects from their treatment
At the 2nd clinic visit each participant will receive 1 single injection of TAK-510 or placebo This will happen 7 days after their last injection from the previous clinic visit They will receive the same dose as their previous dose They will stay in the clinic for 3 days for some tests and check for any side effects from their treatment
After treatment all participants in the study will return to the clinic for a weekly check-up visit for up to 3 weeks
Detailed Description:
The drug being tested in this study is called TAK-510 The study will look at the safety tolerability and PK of TAK-510 in healthy participants
The study will enroll up to approximately 224 healthy participants Participants in each cohort will be randomized to receive treatment with TAK-510 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 3 parts and up to 28 cohorts as mentioned below
TAK-510 Part 1 Single rising dose SRD design to assess the safety immunogenicity tolerability and PK of TAK-510
TAK-510 Part 2 Multiple rising dose MRD design to assess the safety immunogenicity tolerability and PK of TAK-510
TAK-510 Part 3 Dose titration and redosing design to assess the safety immunogenicity tolerability and PK of TAK-510
This multi-center trial will be conducted in the United States The overall duration of the study is approximately 57 days Participants will be followed up for 7 days after the last dose of study drug for a follow-up assessment
The study will enroll up to approximately 224 healthy participants Participants in each cohort will be randomized to receive treatment with TAK-510 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 3 parts and up to 28 cohorts as mentioned below
TAK-510 Part 1 Single rising dose SRD design to assess the safety immunogenicity tolerability and PK of TAK-510
TAK-510 Part 2 Multiple rising dose MRD design to assess the safety immunogenicity tolerability and PK of TAK-510
TAK-510 Part 3 Dose titration and redosing design to assess the safety immunogenicity tolerability and PK of TAK-510
This multi-center trial will be conducted in the United States The overall duration of the study is approximately 57 days Participants will be followed up for 7 days after the last dose of study drug for a follow-up assessment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1261-6974 | REGISTRY | WHO | None |