Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-1944 in Healthy Adults
Lead Sponsor:
ModernaTX, Inc.
Conditions:
Prevention of Chikungunya Virus Infection
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
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-19...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2021
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT03829384
Start Date
January 22 2019
End Date
June 7 2021
Last Update
July 7 2021
Active Locations (1)
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1
PPD Phase 1 Clinical Research Unit
Austin, Texas, United States, 78744