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

Molecular Partners

Status and phase: Terminated; Phase 1

Conditions: COVID-19

Treatments: Drug: Ensovibep; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04870164

2020-004365-39 (EudraCT Number)

MP0420-CP101

Details and patient eligibility

About

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

Enrollment: 53 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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53 participants in 14 patient groups, including a placebo group

ensovibep dose 1 (infusion)

Experimental group

Treatment:

Drug: Ensovibep

ensovibep dose 2 (infusion)

Experimental group

Treatment:

Drug: Ensovibep

ensovibep dose 3 (infusion)

Experimental group

Treatment:

Drug: Ensovibep

placebo (infusion)

Placebo Comparator group

Treatment:

Drug: Placebo

ensovibep dose 4 (IV bolus)

Experimental group

Treatment:

Drug: Ensovibep

ensovibep dose 5 (IV bolus)

Experimental group

Treatment:

Drug: Ensovibep

ensovibep dose 6 (SC injection)

Experimental group

Treatment:

Drug: Ensovibep

ensovibep dose 7 (SC injection)

Experimental group

Treatment:

Drug: Ensovibep

ensovibep dose 8 (SC injection)

Experimental group

Treatment:

Drug: Ensovibep

ensovibep dose 9 (SC injection)

Experimental group

Treatment:

Drug: Ensovibep

ensovibep dose 10 (IM injection)

Experimental group

Treatment:

Drug: Ensovibep

ensovibep dose 11 (IM injection)

Experimental group

Treatment:

Drug: Ensovibep

ensovibep dose 12 (IM injection)

Experimental group

Treatment:

Drug: Ensovibep

ensovibep dose 13 (IM injection)

Experimental group

Treatment:

Drug: Ensovibep