Status:
TERMINATED
Safety, Tolerability and PK of Ensovibep (MP0420 - a New Candidate With Potential for Treatment of COVID-19)
Lead Sponsor:
Molecular Partners AG
Conditions:
COVID-19
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study will investigate how ensovibep is distributed throughout the body, the safety and the tolerability of ensovibep in healthy volunteers
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 6 2022
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT04870164
Start Date
November 18 2020
End Date
January 6 2022
Last Update
March 18 2022
Active Locations (1)
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1
HMR
London, United Kingdom, NW10 7EW