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Trial record 1 of 1 for:    mrna-1944 | Chikungunya
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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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03829384
Recruitment Status : Completed
First Posted : February 4, 2019
Last Update Posted : July 7, 2021
Information provided by (Responsible Party):
ModernaTX, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prevention of Chikungunya Virus Infection Biological: mRNA-1944 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 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
Actual Primary Completion Date : June 7, 2021
Actual Study Completion Date : June 7, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chikungunya

Arm Intervention/treatment
Experimental: mRNA-1944
Escalating dose levels
Biological: mRNA-1944
mRNA encoding Chikungunya antibody

Placebo Comparator: Placebo
Other: Placebo

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Area under the concentration versus time curve (AUC) [ Time Frame: Baseline through 28 days post dose ]
  2. Maximum observed serum concentration (Cmax) after administration of mRNA-1944 [ Time Frame: Baseline through 28 days post dose ]
  3. Time of Cmax (tmax) [ Time Frame: Baseline through 28 days post dose ]
  4. Terminal elimination half-life (t1/2) [ Time Frame: Baseline through 28 days post dose ]
  5. Maximum observed effect (Emax) for chikungunya virus IgG [ Time Frame: Baseline through 13 months ]
  6. Time to maximum observed effect for (TEmax) for chikungunya virus IgG [ Time Frame: Baseline through 13 months ]
  7. Area under the effect curve (AUEC) for chikungunya virus IgG [ Time Frame: Baseline through 13 months ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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

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United States, Texas
PPD Phase 1 Clinical Research Unit
Austin, Texas, United States, 78744
Sponsors and Collaborators
ModernaTX, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT03829384    
Other Study ID Numbers: mRNA-1944-P101
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: June 2021

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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
Viral diseases
Additional relevant MeSH terms:
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Chikungunya Fever
Virus Diseases
Alphavirus Infections
Arbovirus Infections
Vector Borne Diseases
Togaviridae Infections
RNA Virus Infections