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

Phase 1

Completed

• Conditions: Prevention of Chikungunya Virus Infection
• Interventions: Other: Placebo; Biological: mRNA-1944

• Registration Number: NCT03829384
• Lead Sponsor: ModernaTX, Inc.

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-1944 are planned to be investigated in a sequential dose escalation manner.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-22
• Study First Submitted: 2019-02-01
• Study First Submitted QC: 2019-02-01
• Study First Posted: 2019-02-04
• Status Verified: 2021-06
• Primary Completion: 2021-06-07
• Study Completion: 2021-06-07
• Last Update Submitted: 2021-07-05
• Last Update Posted: 2021-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Saline
mRNA-1944	mRNA-1944	Escalating dose levels

Primary Outcome Measures

Name	Time	Method
Frequency of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESI) and laboratory abnormalities	Through 13 months of study participation

Secondary Outcome Measures

Name	Time	Method
Maximum observed effect (Emax) for chikungunya virus IgG	Baseline through 13 months
Area under the effect curve (AUEC) for chikungunya virus IgG	Baseline through 13 months
Time to maximum observed effect for (TEmax) for chikungunya virus IgG	Baseline through 13 months
Area under the concentration versus time curve (AUC)	Baseline through 28 days post dose
Maximum observed serum concentration (Cmax) after administration of mRNA-1944	Baseline through 28 days post dose
Time of Cmax (tmax)	Baseline through 28 days post dose
Terminal elimination half-life (t1/2)	Baseline through 28 days post dose

Trial Locations

Locations (1)

PPD Phase 1 Clinical Research Unit; 🇺🇸 Austin, Texas, United States