Prevention of Chikungunya Virus InfectionPhase 1NCT03829384
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-1944 in Healthy Adults
A Phase 1 study testing mRNA-1944 in people with Prevention of Chikungunya Virus Infection, run by ModernaTX, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Chikungunya Virus Infection
- What is being tested?
- mRNA-1944
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jan 2019to 7 Jun 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
PPD Phase 1 Clinical Research Unit
Austin, Texas, 78744
About this study
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
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.
- Being tested
- mRNA-1944, Placebo
- Keywords
- Chikungunya fever, Alphavirus infections, Togavirus, Viral diseases
- Medical subject headings
- Chikungunya Fever, Alphavirus Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1944Biological
mRNA encoding Chikungunya antibody
PlaceboOther
Saline
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1944 | Experimental | Escalating dose levels Receives: Biological: mRNA-1944 |
| Placebo | Placebo comparator | Saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESI) and laboratory abnormalities
Measured: Through 13 months of study participation
Secondary outcomes (7)
Area under the concentration versus time curve (AUC)
Measured: Baseline through 28 days post dose
Maximum observed serum concentration (Cmax) after administration of mRNA-1944
Measured: Baseline through 28 days post dose
Time of Cmax (tmax)
Measured: Baseline through 28 days post dose
Terminal elimination half-life (t1/2)
Measured: Baseline through 28 days post dose
Maximum observed effect (Emax) for chikungunya virus IgG
Measured: Baseline through 13 months
Time to maximum observed effect for (TEmax) for chikungunya virus IgG
Measured: Baseline through 13 months
Area under the effect curve (AUEC) for chikungunya virus IgG
Measured: Baseline through 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start22 Jan 2019
- Primary completion7 Jun 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prevention of Chikungunya Virus InfectionStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829384
- Sponsor's protocol ID
- mRNA-1944-P101
- Status last verified
- Jun 2021
- First submitted
- 1 Feb 2019
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 35210606August 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.
PubMed 34887572
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03829384
- Acronym / sponsor ID
- mRNA-1944-P101
- Keywords
- Chikungunya fever, Alphavirus infections, Togavirus, Viral diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mRNA-1944 | Experimental | Biological: mRNA-1944Escalating dose levels |
| Placebo | Placebo comparator | Other: PlaceboSaline |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-1944mRNA encoding Chikungunya antibody | Biological | mRNA-1944 |
| PlaceboSaline | Other | Placebo |
Primary outcome
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
7 secondary outcomes
Area under the concentration versus time curve (AUC)
Time frame: Baseline through 28 days post dose
Maximum observed serum concentration (Cmax) after administration of mRNA-1944
Time frame: Baseline through 28 days post dose
Time of Cmax (tmax)
Time frame: Baseline through 28 days post dose
Terminal elimination half-life (t1/2)
Time frame: Baseline through 28 days post dose
Maximum observed effect (Emax) for chikungunya virus IgG
Time frame: Baseline through 13 months
Time to maximum observed effect for (TEmax) for chikungunya virus IgG
Time frame: Baseline through 13 months
Area under the effect curve (AUEC) for chikungunya virus IgG
Time frame: Baseline through 13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Derived from this study: PubMed 35210606Deng 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.
- Derived from this study: PubMed 34887572August 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mRNA-1944 in people with Prevention of Chikungunya Virus Infection, run by ModernaTX, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03829384, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.