A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.
A Phase 1a/b Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19
1 other identifier
interventional
80
1 country
2
Brief Summary
This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics, anti-drug antibodies, and neutralizing activity of MDX2301 administered by intravenous (IV), intramuscular (IM), or subcutaneous (SC) routes in healthy adults and adults at higher risk for severe COVID-19. Participants will receive single IV, IM, and SC doses of MDX2301 or placebo and a repeat IM or SC dose approximately 3 months apart of MDX2301 or placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2026
CompletedFirst Posted
Study publicly available on registry
March 3, 2026
CompletedStudy Start
First participant enrolled
March 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
May 18, 2026
May 1, 2026
1.4 years
February 10, 2026
May 15, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Events
Incidence and severity of adverse events (AEs) and serious AEs (SAEs), including changes in clinical laboratory parameters.
Baseline until end of study, up to approximately 12 months
Secondary Outcomes (7)
Measure of maximum serum concentration (Cmax) of MDX2301
12 months
Measure of time to maximum concentration (Tmax) of MDX2301
12 months
Measure of terminal half-life (t1/2) of MDX2301
12 months
Measure of area under the serum concentration-time curve (AUC) extrapolated to infinity of MDX2301
12 months
Measure of volume of distribution (Vd) of MDX2301
12 months
- +2 more secondary outcomes
Study Arms (6)
Single Dose Healthy Adults MDX2301
EXPERIMENTALHealthy Adults will receive a single dose of MDX2301 as intravenous infusion, intramuscular injection, or subcutaneous injection.
Single Dose Healthy Adults Placebo
PLACEBO COMPARATORHealthy Adults will receive a single dose of placebo as intravenous infusion, intramuscular injection, or subcutaneous injection.
Repeat Dose Healthy Adults MDX2301
EXPERIMENTALHealthy Adults will receive a single dose of MDX2301 as intramuscular injection or subcutaneous injection and then receive a repeat dose of MDX2301, 3 months later as intramuscular injection or subcutaneous injection.
Repeat Dose Healthy Adults Placebo
PLACEBO COMPARATORHealthy Adults will receive a single dose of placebo as intramuscular injection or subcutaneous injection and then receive a repeat dose of placebo 3 months later as intramuscular injection or subcutaneous injection.
Single-Dose Higher Risk Adults MDX2301
EXPERIMENTALAdults at higher risk for severe COVID-19 will receive a single dose of MDX2301 as intramuscular injection or subcutaneous injection.
Single-Dose Higher Risk Adults Placebo
PLACEBO COMPARATORAdults at higher risk for severe COVID-19 will receive a single dose of placebo as intramuscular injection or subcutaneous injection.
Interventions
MDX2301 as intravenous infusion, intramuscular injection, or subcutaneous injection.
Placebo as intravenous infusion, intramuscular injection, or subcutaneous injection.
Eligibility Criteria
You may qualify if:
- Healthy Adults
- Participant is a healthy male or female, 18 to 64 years of age.
- Participant is in good health in the opinion of the investigator.
- Adults at Higher Risk for Developing Severe COVID-19:
- Participant is a male or female, 18 to 64 years of age.
- Participant is at higher risk for developing severe COVID-19, with 1 or more of the following risk factors:
- Asthma
- Diabetes
- Cerebrovascular disease, which affects blood flow to the brain.
- Chronic kidney disease
- Chronic lung disease
- Cardiac disease
- Chronic liver disease
- Cystic fibrosis
- HIV clinically stable on antiretroviral therapy for at least 6 months prior to screening.
- +8 more criteria
You may not qualify if:
- Healthy Adults
- Participant has any chronic or significant medical condition that, in the opinion of the investigator, might compromise the participant's safety or interfere with evaluation of the study drug.
- Participant has evidence of active HIV, hepatitis B, or hepatitis C infections at screening.
- Adults at Higher Risk for Severe COVID-19:
- Participant has any serious disease, condition, or disorder that, in the opinion of the investigator, might compromise the participant's safety or interfere with evaluation of the study drug or interpretation of study results, or may lead to hospitalization or death within the study period.
- Participant has evidence of active hepatitis B or hepatitis C infections at screening.
- All Participants
- Participant has abnormal vital signs, ECG findings, or laboratory values at Screening or Day -1.
- Participant tests positive for SARS-CoV-2 infection at screening.
- Participant self-reports having COVID-19 or received COVID-19 antiviral for prophylaxis or treatment prior to Day 1.
- Participant has received a SARS-CoV-2 vaccine prior to dosing.
- Participant has received a monoclonal antibody (mAb) for SARS-CoV-2 or convalescent plasma for SARS-CoV-2 prior to Day 1.
- Participant has received or is expected to receive for the duration of the study immunoglobulin, blood-derived products, high-dose systemic corticosteroids, or other immunosuppressant drugs within 6 months prior to Day 1.
- Participant is pregnant, breastfeeding, or seeking pregnancy while on the study.
- Participant with a known clinically significant bleeding disorder that would prohibit the participant from receiving an IV infusion or IM or SC injection.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
TrialMed Clinical Research Unit
Las Vegas, Nevada, 89113, United States
TrialMed Clinical Research Unit
Austin, Texas, 78744, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Trial Med
TrialMed
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor staff will remain blinded until two administrative looks are conducted in order to facilitate future study planning.
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2026
First Posted
March 3, 2026
Study Start
March 24, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
May 18, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share