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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-22

Study Completion Date

2021-06-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Prevention of Chikungunya Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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mRNA-1944

Escalating dose levels

Group Type EXPERIMENTAL

mRNA-1944

Intervention Type BIOLOGICAL

mRNA encoding Chikungunya antibody

Placebo

Saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Saline

Interventions

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mRNA-1944

mRNA encoding Chikungunya antibody

Intervention Type BIOLOGICAL

Placebo

Saline

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes