Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-1944 in Healthy Adults
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
1 other identifier
interventional
39
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2019
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2019
CompletedFirst Submitted
Initial submission to the registry
February 1, 2019
CompletedFirst Posted
Study publicly available on registry
February 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2021
CompletedJuly 7, 2021
June 1, 2021
2.4 years
February 1, 2019
July 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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
Maximum observed effect (Emax) for chikungunya virus IgG
Baseline through 13 months
- +2 more secondary outcomes
Study Arms (2)
mRNA-1944
EXPERIMENTALEscalating dose levels
Placebo
PLACEBO COMPARATORSaline
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ModernaTX, Inc.lead
Study Sites (1)
PPD Phase 1 Clinical Research Unit
Austin, Texas, 78744, United States
Related Publications (2)
Deng YQ, Zhang NN, Zhang YF, Zhong X, Xu S, Qiu HY, Wang TC, Zhao H, Zhou C, Zu SL, Chen Q, Cao TS, Ye Q, Chi H, Duan XH, Lin DD, Zhang XJ, Xie LZ, Gao YW, Ying B, Qin CF. Lipid nanoparticle-encapsulated mRNA antibody provides long-term protection against SARS-CoV-2 in mice and hamsters. Cell Res. 2022 Apr;32(4):375-382. doi: 10.1038/s41422-022-00630-0. Epub 2022 Feb 24.
PMID: 35210606DERIVEDAugust A, Attarwala HZ, Himansu S, Kalidindi S, Lu S, Pajon R, Han S, Lecerf JM, Tomassini JE, Hard M, Ptaszek LM, Crowe JE, Zaks T. A phase 1 trial of lipid-encapsulated mRNA encoding a monoclonal antibody with neutralizing activity against Chikungunya virus. Nat Med. 2021 Dec;27(12):2224-2233. doi: 10.1038/s41591-021-01573-6. Epub 2021 Dec 9.
PMID: 34887572DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2019
First Posted
February 4, 2019
Study Start
January 22, 2019
Primary Completion
June 7, 2021
Study Completion
June 7, 2021
Last Updated
July 7, 2021
Record last verified: 2021-06