Back to resultsSafety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-1944 in Healthy Adults
Primary Purpose
Prevention of Chikungunya Virus Infection
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
mRNA-1944
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Prevention of Chikungunya Virus Infection focused on measuring Chikungunya fever, Alphavirus infections, Togavirus, Viral diseases
Eligibility Criteria
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
Sites / Locations
- PPD Phase 1 Clinical Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
mRNA-1944
Placebo
Arm Description
Escalating dose levels
Saline
Outcomes
Primary Outcome Measures
Frequency of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESI) and laboratory abnormalities
Secondary Outcome Measures
Area under the concentration versus time curve (AUC)
Maximum observed serum concentration (Cmax) after administration of mRNA-1944
Time of Cmax (tmax)
Terminal elimination half-life (t1/2)
Maximum observed effect (Emax) for chikungunya virus IgG
Time to maximum observed effect for (TEmax) for chikungunya virus IgG
Area under the effect curve (AUEC) for chikungunya virus IgG
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03829384
Brief Title
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-1944 in Healthy Adults
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 22, 2019 (Actual)
Primary Completion Date
June 7, 2021 (Actual)
Study Completion Date
June 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Chikungunya Virus Infection
Keywords
Chikungunya fever, Alphavirus infections, Togavirus, Viral diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mRNA-1944
Arm Type
Experimental
Arm Description
Escalating dose levels
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline
Intervention Type
Biological
Intervention Name(s)
mRNA-1944
Intervention Description
mRNA encoding Chikungunya antibody
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Saline
Primary Outcome Measure Information:
Title
Frequency of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESI) and laboratory abnormalities
Time Frame
Through 13 months of study participation
Secondary Outcome Measure Information:
Title
Area under the concentration versus time curve (AUC)
Time Frame
Baseline through 28 days post dose
Title
Maximum observed serum concentration (Cmax) after administration of mRNA-1944
Time Frame
Baseline through 28 days post dose
Title
Time of Cmax (tmax)
Time Frame
Baseline through 28 days post dose
Title
Terminal elimination half-life (t1/2)
Time Frame
Baseline through 28 days post dose
Title
Maximum observed effect (Emax) for chikungunya virus IgG
Time Frame
Baseline through 13 months
Title
Time to maximum observed effect for (TEmax) for chikungunya virus IgG
Time Frame
Baseline through 13 months
Title
Area under the effect curve (AUEC) for chikungunya virus IgG
Time Frame
Baseline through 13 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
PPD Phase 1 Clinical Research Unit
City
Austin
State/Province
Texas
ZIP/Postal Code
78744
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35210606
Citation
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.
Results Reference
derived
PubMed Identifier
34887572
Citation
August 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. Erratum In: Nat Med. 2022 May;28(5):1095-1096.
Results Reference
derived
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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-1944 in Healthy Adults
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