Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460064
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-04-29
Brief Title:
First-in-human Study to Assess the Safety Tolerability and Immunogenicity of the Adjuvanted Universal Influenza Vaccine fH1DSP-0546LP
Sponsor:
Sumitomo Pharma Co Ltd
Organization:
Sumitomo Pharma Co Ltd
Study Overview
Official Title:
A Single Center Randomized Double-blind Placebo-controlled First-in-human Phase 1 Study to Assess the Safety Tolerability and Immunogenicity of the Adjuvanted Universal Influenza Vaccine fH1DSP-0546LP After Intramuscular IM Administrations in Healthy Adults
Status:
RECRUITING
Status Verified Date:
2024-06
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 study is a single center randomized double-blind placebo-controlled dose-finding FIH Phase 1 study to assess the safety tolerability and immunogenicity of the adjuvanted Universal Influenza Vaccine fH1DSP-0546LP after IM administrations in healthy adults
Detailed Description:
This will be a single center randomized placebo-controlled double-blind study In this study safety tolerability and immunogenicity of fH1 formulated with DSP-0546LP will be assessed after IM administration in healthy adults aged 18 to 40 years
This study includes 6 cohorts with a combination of 2 dose levels of fH1 2 and 8 μg 3 dose levels of DSP-0546LP 25 5 and 10 μg and placebo Each dose level of fH1 will be combined with the low medium and high dose level of DSP-0546LP Subjects will receive 2 administrations at 3-week intervals
Randomized subjects will undergo 11 visits including screening 2 administration visits Day 1 and Day 22 2 and follow-up visits on Day 4 1 telephone contact Day 8 1 Day 25 1 telephone contact Day 29 1 Day 36 2 Day 50 4 Day 204 7 and Day 386 10
This study includes 6 cohorts with a combination of 2 dose levels of fH1 2 and 8 μg 3 dose levels of DSP-0546LP 25 5 and 10 μg and placebo Each dose level of fH1 will be combined with the low medium and high dose level of DSP-0546LP Subjects will receive 2 administrations at 3-week intervals
Randomized subjects will undergo 11 visits including screening 2 administration visits Day 1 and Day 22 2 and follow-up visits on Day 4 1 telephone contact Day 8 1 Day 25 1 telephone contact Day 29 1 Day 36 2 Day 50 4 Day 204 7 and Day 386 10
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| 2023-504378-39-00 | REGISTRY | Clinical Trials Information System | None |
| JP19pc0101043 | OTHER_GRANT | None | None |