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

• ClinicalTrials.gov Identifier: NCT03829384
• Recruitment Status: Recruiting
• First Posted: February 4, 2019
• Last Update Posted: February 4, 2019
• Sponsor: ModernaTX, Inc.
• Information provided by (Responsible Party): ModernaTX, Inc.

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 a single dose of mRNA 1944 in healthy adult subjects. Cohorts of mRNA-1944 are planned to be investigated in a sequential dose escalation manner.

Condition or disease	Intervention/treatment	Phase
Prevention of Chikungunya Virus Infection	Biological: mRNA-1944; Other: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: January 22, 2019
• Estimated Primary Completion Date: September 2020
• Estimated Study Completion Date: September 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: mRNA-1944; Escalating dose levels	Biological: mRNA-1944; mRNA encoding Chikungunya antibody
Placebo Comparator: Placebo; Saline	Other: Placebo; Saline

Outcome Measures

Primary Outcome Measures :

1. 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 Measures :

1. Area under the concentration versus time curve (AUC) [ Time Frame: Baseline through 28 days post dose ]
2. Maximum observed serum concentration (Cmax) after administration of mRNA-1944 [ Time Frame: Baseline through 28 days post dose ]
3. Time of Cmax (tmax) [ Time Frame: Baseline through 28 days post dose ]
4. Terminal elimination half-life (t1/2) [ Time Frame: Baseline through 28 days post dose ]
5. Maximum observed effect (Emax) for chikungunya virus IgG [ Time Frame: Baseline through 13 months ]
6. Time to maximum observed effect for (TEmax) for chikungunya virus IgG [ Time Frame: Baseline through 13 months ]
7. Area under the effect curve (AUEC) for chikungunya virus IgG [ Time Frame: Baseline through 13 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 50 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Moderna Clinical Trials; 855-663-6762; clinicaltrials@modernatx.com

Locations

United States, Texas

PPD Phase 1 Clinical Research Unit; Recruiting

Austin, Texas, United States, 78744

Contact 512-747-5359

Sponsors and Collaborators

ModernaTX, Inc.

More Information

• Responsible Party: ModernaTX, Inc.
• ClinicalTrials.gov Identifier: NCT03829384
• Other Study ID Numbers: mRNA-1944-P101
• First Posted: February 4, 2019
• Last Update Posted: February 4, 2019
• Last Verified: February 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ModernaTX, Inc.:

Chikungunya fever; Alphavirus infections; Togavirus; Viral diseases

Additional relevant MeSH terms:

Chikungunya Fever; Virus Diseases; Alphavirus Infections; Togaviridae Infections; RNA Virus Infections