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

Moderna

Status and phase

Completed

Phase 1

Conditions

Prevention of Chikungunya Virus Infection

Treatments

Biological: mRNA-1944

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03829384

mRNA-1944-P101

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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