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

March 3, 2022 updated by: Molecular Partners AG

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)
Time Frame: up to day 100 (EOS)
up to day 100 (EOS)
Vital Signs: Heart Rate (bmp)
Time Frame: up to day 100 (EOS)
up to day 100 (EOS)
Vital Signs: Tympanic Temperature (°C)
Time Frame: up to day 100 (EOS)
up to day 100 (EOS)
Vital Signs: Oxygen Saturation (SpO2%)
Time Frame: up to day 100 (EOS)
up to day 100 (EOS)
Cardiac Safety assessed by 12-lead Electrocardiogram (ECG)
Time Frame: up to day 100 (EOS)
up to day 100 (EOS)
Physical Examination
Time Frame: up to day 100 (EOS)
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
Time Frame: up to day 100 (EOS)
up to day 100 (EOS)
Assessment of local tolerability
Time Frame: up to day 100 (EOS)
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
Time Frame: up to day 100 (EOS)
up to day 100 (EOS)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Observed maximum concentration (Cmax)
Time Frame: up to day 100 (EOS)
The maximum observed concentration (Cmax) is estimated based on the serum concentrations.
up to day 100 (EOS)
Time to Cmax (Tmax)
Time Frame: up to day 100 (EOS)
up to day 100 (EOS)
The area under the serum concentration-time curve (AUC)
Time Frame: up to day 100 (EOS)
up to day 100 (EOS)
Apparent total body clearance of the drug from plasma (CL)
Time Frame: up to day 100 (EOS)
up to day 100 (EOS)
The apparent volume of distribution during terminal phase after drug administration (Vz)
Time Frame: up to day 100 (EOS)
up to day 100 (EOS)
Terminal Elimination Half-Life (T½)
Time Frame: up to day 100 (EOS)
up to day 100 (EOS)
Proportion of subjects with treatment-emergent anti-drug antibodies (ADA)
Time Frame: up to day 100 (EOS)
up to day 100 (EOS)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Molecular Partners AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 18, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 6, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 6, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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