Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of mRNA-1944 in Healthy Adults.
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03829384 |
Recruitment Status :
Recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prevention of Chikungunya Virus Infection | Biological: mRNA-1944 Other: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Phase 1, Randomized, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-1944, Encoding for an Anti-Chikungunya Virus Monoclonal Antibody, in Healthy Adults |
Actual Study Start Date : | January 22, 2019 |
Estimated Primary Completion Date : | September 2020 |
Estimated Study Completion Date : | September 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: mRNA-1944
Escalating dose levels
|
Biological: mRNA-1944
mRNA encoding Chikungunya antibody |
Placebo Comparator: Placebo
Saline
|
Other: Placebo
Saline |
- Frequency of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESI) and laboratory abnormalities [ Time Frame: Through 13 months of study participation ]
- Area under the concentration versus time curve (AUC) [ Time Frame: Baseline through 28 days post dose ]
- Maximum observed serum concentration (Cmax) after administration of mRNA-1944 [ Time Frame: Baseline through 28 days post dose ]
- Time of Cmax (tmax) [ Time Frame: Baseline through 28 days post dose ]
- Terminal elimination half-life (t1/2) [ Time Frame: Baseline through 28 days post dose ]
- Maximum observed effect (Emax) for chikungunya virus IgG [ Time Frame: Baseline through 13 months ]
- Time to maximum observed effect for (TEmax) for chikungunya virus IgG [ Time Frame: Baseline through 13 months ]
- Area under the effect curve (AUEC) for chikungunya virus IgG [ Time Frame: Baseline through 13 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male or female ≥ 18 and ≤ 50 years of age
- Weight of 50 to 100 kg, inclusive
- In good general health as determined by medical history, clinical laboratory assessments, ECG results, vital sign measurements, and physical examination findings at screening
- Has access to consistent and reliable means of contact and agrees to stay in contact with the study site for the duration of the study
Exclusion Criteria:
- Any acute or chronic clinically significant disease, as determined by physical examination or laboratory screening tests
- Elevated liver function tests or safety laboratory test results
- Positive screening test for the presence of anti-CHIKV IgG
- Administration of another investigational study involving any investigational product within 60 days or 5 half-lives, whichever is longer
- Has received any live attenuated or inactive vaccines within 4 weeks prior to check-in, or plans to receive any vaccine during the study
- Known or suspected immune-mediated disease or immunosuppressive condition (including lymphoproliferative disorders)
- Any neurologic disorder
- History of idiopathic urticaria
- Any bleeding disorder that is considered a contraindication to study drug infusion or blood collection
- Receipt of immunoglobulins, a monoclonal antibody or any blood products within the preceding 6 months
- Any acute illness at the time of enrollment
- A positive test result for drugs of abuse
- A positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus type 1 or 2 antibodies
- A history of active cancer (malignancy) in the last 3 years
- Donation of ≥ 450 mL blood or blood products within 30 days of study drug infusion

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03829384
Contact: Moderna Clinical Trials | 855-663-6762 | clinicaltrials@modernatx.com |
United States, Texas | |
PPD Phase 1 Clinical Research Unit | Recruiting |
Austin, Texas, United States, 78744 | |
Contact 512-747-5359 |
Responsible Party: | ModernaTX, Inc. |
ClinicalTrials.gov Identifier: | NCT03829384 History of Changes |
Other Study ID Numbers: |
mRNA-1944-P101 |
First Posted: | February 4, 2019 Key Record Dates |
Last Update Posted: | February 4, 2019 |
Last Verified: | February 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by ModernaTX, Inc.:
Chikungunya fever Alphavirus infections Togavirus Viral diseases |
Additional relevant MeSH terms:
Virus Diseases Chikungunya Fever Alphavirus Infections Togaviridae Infections RNA Virus Infections |