Prevention of Chikungunya Virus Infection Clinical Trial
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
| Verified date | June 2021 |
| Source | ModernaTX, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 39 |
| Est. completion date | June 7, 2021 |
| Est. primary completion date | June 7, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 50 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | PPD Phase 1 Clinical Research Unit | Austin | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| ModernaTX, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Area under the concentration versus time curve (AUC) | Baseline through 28 days post dose | ||
| Secondary | Maximum observed serum concentration (Cmax) after administration of mRNA-1944 | Baseline through 28 days post dose | ||
| Secondary | Time of Cmax (tmax) | Baseline through 28 days post dose | ||
| Secondary | Terminal elimination half-life (t1/2) | Baseline through 28 days post dose | ||
| Secondary | Maximum observed effect (Emax) for chikungunya virus IgG | Baseline through 13 months | ||
| Secondary | Time to maximum observed effect for (TEmax) for chikungunya virus IgG | Baseline through 13 months | ||
| Secondary | Area under the effect curve (AUEC) for chikungunya virus IgG | Baseline through 13 months |