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
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.
• 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.
∙ Sickle cell disease or thalassemia
• Participant is clinically stable with no clinically significant abnormalities.
• Participant has not been hospitalized within the 12 months prior to screening or is not expected to be hospitalized during the study due to underlying medical conditions.
• All Participants
• Female participants of childbearing potential must have a negative urine pregnancy test.
• Female participants of childbearing potential must agree to follow instructions for a highly effective birth control method.
• Participant is able to understand and sign the informed consent form prior to undergoing any study procedures.
⁃ Participant is willing and able to comply with scheduled visits and procedures.