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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2071200110 | Other Identifier | Japan Registry of Clinical Trial |
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This study will assess the safety, tolerability and immunogenicity of DS-5670a (COVID-19 Vaccine) and determine the recommended dose in Japanese healthy adults and elderly participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A1: DS-5670a 10 µg | Experimental | Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg. |
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| Cohort A2: DS-5670a 30 µg | Experimental | Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg. |
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| Cohort A3: DS-5670a 60 µg | Experimental | Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg. |
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| Cohort A4: DS-5670a 100 µg | Experimental | Healthy adults participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg. |
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| Cohort A: Placebo | Placebo Comparator | Healthy adults participants will be randomized to receive a intramuscular injection of placebo. |
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| Cohort B1: DS-5670a 10 µg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS-5670a | Biological | DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Treatment-emergent Adverse Events | Day 1 up to Day 57 post-dose | |
| Number of Participants Reporting Local and Systemic Adverse Events | Day 1 up to Day 14 post-first and second dose | |
| Number of Participants Reporting Serious Events | Day 1 up to 12 months post-second dose | |
| Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody | Days 15, 29, 43, and 57 post-dose | |
| Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific Neutralizing Antibody | Days 15, 29, 43, and 57 post-dose | |
| Seroconversion Rates of SARS-CoV-2 Specific Neutralizing Antibody | Days 15, 29, 43, and 57 post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| GMT of anti-IgG Antibody | Days 15, 29, 43, and 57 post-dose | |
| GMFR of anti-IgG Antibody | Days 15, 29, 43, and 57 post-dose | |
| Seroconversion Rates of anti-IgG Antibody |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SOUSEIKAI Hakata Clinic | Hakata | Fukuoka | 812-0025 | Japan |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Experimental |
Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 10 µg. |
|
| Cohort B2: DS-5670a 30 µg | Experimental | Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 30 µg. |
|
| Cohort B3: DS-5670a 60 µg | Experimental | Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 60 µg. |
|
| Cohort B4: DS-5670a 100 µg | Experimental | Healthy elderly participants will be randomized to receive a intramuscular injection of DS-5670a 100 µg. |
|
| Cohort B: Placebo | Placebo Comparator | Healthy elderly participants will be randomized to receive a intramuscular injection of placebo. |
|
| Placebo | Biological | Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total |
|
| Days 15, 29, 43, and 57 post-dose |
| Pharmacokinetic Parameter of Maximum (Peak) Observed Plasma Concentration (Cmax) Following Intramuscular Injection of DS-5670a | Cmax of plasma MAFB-7566a and constituent lipids of lipid nanoparticle (LNP) will be assessed. | Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose |
| Pharmacokinetic Parameter of Time to Reach Maximum Concentration (Tmax) Following Intramuscular Injection of DS-5670a | Tmax of plasma MAFB-7566a and constituent lipids of LNP will be assessed. | Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose |
| Pharmacokinetic Parameter of Area Under the Concentration-time Curve Following Intramuscular Injection of DS-5670a | Area under the concentration-time curve from time 0 to last measurable time point (AUClast) and time 0 to infinity (AUCinf) of plasma MAFB-7566a and constituent lipids of LNP will be assessed. | Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose |
| Pharmacokinetic Parameter of Apparent Total Body Clearance (CL/F) Following Intramuscular Injection of DS-5670a | CL/F of plasma MAFB-7566a and constituent lipids of LNP will be assessed. | Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose |
| Pharmacokinetic Parameter of Terminal Elimination Half-life (t1/2) Following Intramuscular Injection of DS-5670a | Half-life (t1/2) of plasma MAFB-7566a and constituent lipids of LNP will be assessed. | Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose |
| Pharmacokinetic Parameter of Apparent Volume of Distribution (Vz/F) Following Intramuscular Injection of DS-5670a | Vz/F of plasma MAFB-7566a and constituent lipids of LNP will be assessed. | Days 1, 2, 4, 8, 15, 29, 30, 32, 36, 43, and 57 post-dose |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |