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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of mRNA-1944 in Healthy Adults.

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ClinicalTrials.gov Identifier: NCT03829384
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Description
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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 a single dose 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

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chikungunya

Arms and Interventions
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Arm Intervention/treatment
Experimental: mRNA-1944
Escalating dose levels
 Biological: mRNA-1944
mRNA encoding Chikungunya antibody
Placebo Comparator: Placebo
Saline
 Other: Placebo
Saline


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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


Contacts
Contact: Moderna Clinical Trials 855-663-6762 clinicaltrials@modernatx.com

Locations
United States, Texas
PPD Phase 1 Clinical Research Unit Recruiting
Austin, Texas, United States, 78744
Contact    512-747-5359      
Sponsors and Collaborators
ModernaTX, Inc.
More Information
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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