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This is a Phase 1, FIH, single-center, randomized, placebo controlled, dose escalation study to evaluate the safety, tolerability, PK, and PD of mRNA-1944 in healthy adult subjects. Cohorts of mRNA-1944 are planned to be investigated in a sequential dose escalation manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1944 | Experimental | Escalating dose levels |
|
| Placebo | Placebo Comparator | Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1944 | Biological | mRNA encoding Chikungunya antibody |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESI) and laboratory abnormalities | Through 13 months of study participation |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration versus time curve (AUC) | Baseline through 28 days post dose | |
| Maximum observed serum concentration (Cmax) after administration of mRNA-1944 | Baseline through 28 days post dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Phase 1 Clinical Research Unit | Austin | Texas | 78744 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35210606 | Derived | Deng YQ, Zhang NN, Zhang YF, Zhong X, Xu S, Qiu HY, Wang TC, Zhao H, Zhou C, Zu SL, Chen Q, Cao TS, Ye Q, Chi H, Duan XH, Lin DD, Zhang XJ, Xie LZ, Gao YW, Ying B, Qin CF. Lipid nanoparticle-encapsulated mRNA antibody provides long-term protection against SARS-CoV-2 in mice and hamsters. Cell Res. 2022 Apr;32(4):375-382. doi: 10.1038/s41422-022-00630-0. Epub 2022 Feb 24. | |
| 34887572 |
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| ID | Term |
|---|---|
| D065632 | Chikungunya Fever |
| D018354 | Alphavirus Infections |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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| Placebo |
| Other |
Saline |
|
| Time of Cmax (tmax) | Baseline through 28 days post dose |
| Terminal elimination half-life (t1/2) | Baseline through 28 days post dose |
| Maximum observed effect (Emax) for chikungunya virus IgG | Baseline through 13 months |
| Time to maximum observed effect for (TEmax) for chikungunya virus IgG | Baseline through 13 months |
| Area under the effect curve (AUEC) for chikungunya virus IgG | Baseline through 13 months |
| Derived |
| August A, Attarwala HZ, Himansu S, Kalidindi S, Lu S, Pajon R, Han S, Lecerf JM, Tomassini JE, Hard M, Ptaszek LM, Crowe JE, Zaks T. A phase 1 trial of lipid-encapsulated mRNA encoding a monoclonal antibody with neutralizing activity against Chikungunya virus. Nat Med. 2021 Dec;27(12):2224-2233. doi: 10.1038/s41591-021-01573-6. Epub 2021 Dec 9. |
| D014036 |
| Togaviridae Infections |
| D012327 | RNA Virus Infections |