Health TrialsbyHealthPanel

A Study Evaluating MDX2301 in Healthy Adults and Adults at Higher Risk for Severe COVID-19.

ConditionsCOVID -19COVID-19 (Prevention)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-64
SponsorModeX Therapeutics, An OPKO Health Company

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participant is a healthy male or female, 18 to 64 years of age.

Participant is in good health in the opinion of the investigator.

Participant is a male or female, 18 to 64 years of age.

Asthma

Disqualifiers

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.

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • MDX2301

    Biological/Vaccine

    MDX2301 as intravenous infusion, intramuscular injection, or subcutaneous injection.

  • Normal Saline

    Biological/Vaccine

    Placebo as intravenous infusion, intramuscular injection, or subcutaneous injection.

  • Normal Saline

    Biological/Vaccine

    Placebo as intramuscular injection or subcutaneous injection.

  • MDX2301

    Biological/Vaccine

    MDX2301 as intramuscular injection or subcutaneous injection.

Treatment groups

80 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Single Dose Healthy Adults MDX2301Experimental treatment 1 intervention
Group B: Single Dose Healthy Adults PlaceboPlacebo comparator 1 intervention
Group C: Repeat Dose Healthy Adults MDX2301Experimental treatment 1 intervention
Group D: Repeat Dose Healthy Adults PlaceboPlacebo comparator 1 intervention
Group E: Single-Dose Higher Risk Adults MDX2301Experimental treatment 1 intervention
Group F: Single-Dose Higher Risk Adults PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events

Incidence and severity of adverse events (AEs) and serious AEs (SAEs), including changes in clinical laboratory parameters.

Time frame
Baseline until end of study, up to approximately 12 months

Secondary outcomes

1

Measure of maximum serum concentration (Cmax) of MDX2301

Characterize pharmacokinetic (PK) parameter Cmax after administration of MDX2301

Time frame
12 months
2

Measure of time to maximum concentration (Tmax) of MDX2301

Characterize pharmacokinetic (PK) parameter Tmax after administration of MDX2301

Time frame
12 months
3

Measure of terminal half-life (t1/2) of MDX2301

Characterize pharmacokinetic (PK) parameter t1/2 after administration of MDX2301.

Time frame
12 months
4

Measure of area under the serum concentration-time curve (AUC) extrapolated to infinity of MDX2301

Characterize pharmacokinetic (PK) parameters AUC after administration of MDX2301

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ModeX Therapeutics, An OPKO Health Company

Lead sponsor

Source ClinicalTrials.gov
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