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

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Molecular Partners AG

Criteria

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.