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

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Drug: Ensovibep; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, NW10 7EW
    • HMR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

14

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ensovibep dose 1 (infusion)	Drug: Ensovibep; The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohorts. 3 IV infusion, 2 IV bolus, 4 subcutaneous and 4 intramuscular cohorts are planned. Subjects receive one or two administration(s) on day 1, depending on the cohort.; Other Names: MP0420; DARPin; COVID-19 treatment
Experimental: ensovibep dose 2 (infusion)	Drug: Ensovibep; The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohorts. 3 IV infusion, 2 IV bolus, 4 subcutaneous and 4 intramuscular cohorts are planned. Subjects receive one or two administration(s) on day 1, depending on the cohort.; Other Names: MP0420; DARPin; COVID-19 treatment
Experimental: ensovibep dose 3 (infusion)	Drug: Ensovibep; The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohorts. 3 IV infusion, 2 IV bolus, 4 subcutaneous and 4 intramuscular cohorts are planned. Subjects receive one or two administration(s) on day 1, depending on the cohort.; Other Names: MP0420; DARPin; COVID-19 treatment
Placebo Comparator: placebo (infusion)	Drug: Placebo; One administration at day 1 by infusion.
Experimental: ensovibep dose 4 (IV bolus)	Drug: Ensovibep; The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohorts. 3 IV infusion, 2 IV bolus, 4 subcutaneous and 4 intramuscular cohorts are planned. Subjects receive one or two administration(s) on day 1, depending on the cohort.; Other Names: MP0420; DARPin; COVID-19 treatment
Experimental: ensovibep dose 5 (IV bolus)	Drug: Ensovibep; The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohorts. 3 IV infusion, 2 IV bolus, 4 subcutaneous and 4 intramuscular cohorts are planned. Subjects receive one or two administration(s) on day 1, depending on the cohort.; Other Names: MP0420; DARPin; COVID-19 treatment
Experimental: ensovibep dose 6 (SC injection)	Drug: Ensovibep; The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohorts. 3 IV infusion, 2 IV bolus, 4 subcutaneous and 4 intramuscular cohorts are planned. Subjects receive one or two administration(s) on day 1, depending on the cohort.; Other Names: MP0420; DARPin; COVID-19 treatment
Experimental: ensovibep dose 7 (SC injection)	Drug: Ensovibep; The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohorts. 3 IV infusion, 2 IV bolus, 4 subcutaneous and 4 intramuscular cohorts are planned. Subjects receive one or two administration(s) on day 1, depending on the cohort.; Other Names: MP0420; DARPin; COVID-19 treatment
Experimental: ensovibep dose 8 (SC injection)	Drug: Ensovibep; The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohorts. 3 IV infusion, 2 IV bolus, 4 subcutaneous and 4 intramuscular cohorts are planned. Subjects receive one or two administration(s) on day 1, depending on the cohort.; Other Names: MP0420; DARPin; COVID-19 treatment
Experimental: ensovibep dose 9 (SC injection)	Drug: Ensovibep; The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohorts. 3 IV infusion, 2 IV bolus, 4 subcutaneous and 4 intramuscular cohorts are planned. Subjects receive one or two administration(s) on day 1, depending on the cohort.; Other Names: MP0420; DARPin; COVID-19 treatment
Experimental: ensovibep dose 10 (IM injection)	Drug: Ensovibep; The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohorts. 3 IV infusion, 2 IV bolus, 4 subcutaneous and 4 intramuscular cohorts are planned. Subjects receive one or two administration(s) on day 1, depending on the cohort.; Other Names: MP0420; DARPin; COVID-19 treatment
Experimental: ensovibep dose 11 (IM injection)	Drug: Ensovibep; The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohorts. 3 IV infusion, 2 IV bolus, 4 subcutaneous and 4 intramuscular cohorts are planned. Subjects receive one or two administration(s) on day 1, depending on the cohort.; Other Names: MP0420; DARPin; COVID-19 treatment
Experimental: ensovibep dose 12 (IM injection)	Drug: Ensovibep; The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohorts. 3 IV infusion, 2 IV bolus, 4 subcutaneous and 4 intramuscular cohorts are planned. Subjects receive one or two administration(s) on day 1, depending on the cohort.; Other Names: MP0420; DARPin; COVID-19 treatment
Experimental: ensovibep dose 13 (IM injection)	Drug: Ensovibep; The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohorts. 3 IV infusion, 2 IV bolus, 4 subcutaneous and 4 intramuscular cohorts are planned. Subjects receive one or two administration(s) on day 1, depending on the cohort.; Other Names: MP0420; DARPin; COVID-19 treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)		up to day 100 (EOS)
Vital Signs: Heart Rate (bmp)		up to day 100 (EOS)
Vital Signs: Tympanic Temperature (°C)		up to day 100 (EOS)
Vital Signs: Oxygen Saturation (SpO2%)		up to day 100 (EOS)
Cardiac Safety assessed by 12-lead Electrocardiogram (ECG)		up to day 100 (EOS)
Physical Examination	For safety purpose, the following will be examined during full physical examinations: general appearance; head, ears, eyes, nose and throat; thyroid; lymph nodes; back and neck; heart; chest; lungs; abdomen; skin; and extremities; and the following systems will be assessed: musculoskeletal and neurological.	up to day 100 (EOS)
Number of subjects with Laboratory Abnormalities		up to day 100 (EOS)
Assessment of local tolerability	Number of subjects with reaction at the injection site. The injection site is assessed for any pain, tenderness, erythema and induration.	up to day 100 (EOS)
Number of subjects with Adverse Events		up to day 100 (EOS)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observed maximum concentration (Cmax)	The maximum observed concentration (Cmax) is estimated based on the serum concentrations.	up to day 100 (EOS)
Time to Cmax (Tmax)		up to day 100 (EOS)
The area under the serum concentration-time curve (AUC)		up to day 100 (EOS)
Apparent total body clearance of the drug from plasma (CL)		up to day 100 (EOS)
The apparent volume of distribution during terminal phase after drug administration (Vz)		up to day 100 (EOS)
Terminal Elimination Half-Life (T½)		up to day 100 (EOS)
Proportion of subjects with treatment-emergent anti-drug antibodies (ADA)		up to day 100 (EOS)

Collaborators and Investigators

• Sponsor: Molecular Partners AG

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2020
• Primary Completion (Actual): January 6, 2022
• Study Completion (Actual): January 6, 2022

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2022
• Last Update Submitted That Met QC Criteria: March 3, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Corona; ensovibep; COVID-19 treatment; designed ankyrin repeat protein (DARPin®); angiotensin-converting enzyme 2 (ACE2)
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: MP0420-CP101; 2020-004365-39 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No