Safety, Tolerability and PK of Ensovibep (MP0420 - a New Candidate With Potential for Treatment of COVID-19)

A Phase 1, First-time-in-human, Dose Ascending Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MP0420 (a Novel Drug Candidate With Potential for Treatment of COVID-19) in Healthy Volunteers

This study will investigate how ensovibep is distributed throughout the body, the safety and the tolerability of ensovibep in healthy volunteers

Inclusion Criteria:

• Healthy male or female subjects between ages of 18-65 years
• Body mass index of 18.0-35.0 kg/m2
• Non-smokers for at least 3 months
• Deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine
• Agree to follow the contraception requirements of the trial
• Able to give fully informed written consent.

Exclusion Criteria:

• Positive tests for hepatitis B & C, HIV
• Severe adverse reaction to any drug
• Drug or alcohol abuse
• Use of over-the-counter medication (with the exception of paracetamol [acetaminophen]) during the 7 days before the first dose of trial medication, or prescribed medication during the 28 days before first dose of trial medication
• Any vaccination within 4 weeks before dose of trial medication
• Participation in other clinical trials of unlicensed medicines within the previous 3 months
• Loss of more than 400 mL blood within the previous 3 months
• Vital signs outside the acceptable range
• Clinically relevant abnormal findings at the screening assessment
• Acute or chronic illness
• Clinically relevant abnormal medical history or concurrent medical condition
• Possibility that volunteer will not cooperate
• Females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception.