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

Sponsor

Molecular Partners AG (Industry)

Overall Status

Terminated

CT.gov ID

NCT04870164

Collaborator

(none)

Enrollment

Location

Arms

13.6

Actual Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Ensovibep Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

53 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Parallel (Part A) Sequential (Part B and Part C)Parallel (Part A) Sequential (Part B and Part C)

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Part A only

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Nov 18, 2020

Actual Primary Completion Date :

Jan 6, 2022

Actual Study Completion Date :

Jan 6, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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 [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.
Number of subjects with Laboratory Abnormalities [up to day 100 (EOS)]
Assessment of local tolerability [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.
Number of subjects with Adverse Events [up to day 100 (EOS)]

Secondary Outcome Measures

Observed maximum concentration (Cmax) [up to day 100 (EOS)]
The maximum observed concentration (Cmax) is estimated based on the serum concentrations.
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.