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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.

Tracking Information
First Submitted Date  ICMJE February 1, 2019
First Posted Date  ICMJE February 4, 2019
Last Update Posted Date February 4, 2019
Actual Study Start Date  ICMJE January 22, 2019
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of mRNA-1944 in Healthy Adults.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Prevention of Chikungunya Virus Infection
Intervention  ICMJE
  • Biological: mRNA-1944
    mRNA encoding Chikungunya antibody
  • Other: Placebo
    Saline
Study Arms
  • Experimental: mRNA-1944
    Escalating dose levels
    Intervention: Biological: mRNA-1944
  • Placebo Comparator: Placebo
    Saline
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 1, 2019)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE
Contact: Moderna Clinical Trials 855-663-6762 clinicaltrials@modernatx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03829384
Other Study ID Numbers  ICMJE mRNA-1944-P101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party ModernaTX, Inc.
Study Sponsor  ICMJE ModernaTX, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ModernaTX, Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP