Back to resultsSafety, Tolerability and PK of Ensovibep (MP0420 - a New Candidate With Potential for Treatment of COVID-19)
Primary Purpose
COVID-19
Status
Terminated
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Ensovibep
Placebo
Sponsored by
About this trial
This is an interventional other trial for COVID-19 focused on measuring ensovibep, COVID-19 treatment, SARS-CoV-2, Corona, designed ankyrin repeat protein (DARPin®), angiotensin-converting enzyme 2 (ACE2)
Eligibility Criteria
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.
Sites / Locations
- HMR
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
ensovibep dose 1 (infusion)
ensovibep dose 2 (infusion)
ensovibep dose 3 (infusion)
placebo (infusion)
ensovibep dose 4 (IV bolus)
ensovibep dose 5 (IV bolus)
ensovibep dose 6 (SC injection)
ensovibep dose 7 (SC injection)
ensovibep dose 8 (SC injection)
ensovibep dose 9 (SC injection)
ensovibep dose 10 (IM injection)
ensovibep dose 11 (IM injection)
ensovibep dose 12 (IM injection)
ensovibep dose 13 (IM injection)
Arm Description
Outcomes
Primary Outcome Measures
Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)
Vital Signs: Heart Rate (bmp)
Vital Signs: Tympanic Temperature (°C)
Vital Signs: Oxygen Saturation (SpO2%)
Cardiac Safety assessed by 12-lead Electrocardiogram (ECG)
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.
Number of subjects with Laboratory Abnormalities
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.
Number of subjects with Adverse Events
Secondary Outcome Measures
Observed maximum concentration (Cmax)
The maximum observed concentration (Cmax) is estimated based on the serum concentrations.
Time to Cmax (Tmax)
The area under the serum concentration-time curve (AUC)
Apparent total body clearance of the drug from plasma (CL)
The apparent volume of distribution during terminal phase after drug administration (Vz)
Terminal Elimination Half-Life (T½)
Proportion of subjects with treatment-emergent anti-drug antibodies (ADA)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04870164
Brief Title
Safety, Tolerability and PK of Ensovibep (MP0420 - a New Candidate With Potential for Treatment of COVID-19)
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to hypersensitivity observed in 3 subjects, although no stopping rules were met, the Sponsor decided to halt recruitment for further investigation. After analysis of PK, i.m. administration was not required, and recruitment stopped.
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
January 6, 2022 (Actual)
Study Completion Date
January 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Molecular Partners AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
ensovibep, COVID-19 treatment, SARS-CoV-2, Corona, designed ankyrin repeat protein (DARPin®), angiotensin-converting enzyme 2 (ACE2)
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Parallel (Part A) Sequential (Part B and Part C)
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Part A only
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ensovibep dose 1 (infusion)
Arm Type
Experimental
Arm Title
ensovibep dose 2 (infusion)
Arm Type
Experimental
Arm Title
ensovibep dose 3 (infusion)
Arm Type
Experimental
Arm Title
placebo (infusion)
Arm Type
Placebo Comparator
Arm Title
ensovibep dose 4 (IV bolus)
Arm Type
Experimental
Arm Title
ensovibep dose 5 (IV bolus)
Arm Type
Experimental
Arm Title
ensovibep dose 6 (SC injection)
Arm Type
Experimental
Arm Title
ensovibep dose 7 (SC injection)
Arm Type
Experimental
Arm Title
ensovibep dose 8 (SC injection)
Arm Type
Experimental
Arm Title
ensovibep dose 9 (SC injection)
Arm Type
Experimental
Arm Title
ensovibep dose 10 (IM injection)
Arm Type
Experimental
Arm Title
ensovibep dose 11 (IM injection)
Arm Type
Experimental
Arm Title
ensovibep dose 12 (IM injection)
Arm Type
Experimental
Arm Title
ensovibep dose 13 (IM injection)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ensovibep
Other Intervention Name(s)
MP0420, DARPin, COVID-19 treatment
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One administration at day 1 by infusion.
Primary Outcome Measure Information:
Title
Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)
Time Frame
up to day 100 (EOS)
Title
Vital Signs: Heart Rate (bmp)
Time Frame
up to day 100 (EOS)
Title
Vital Signs: Tympanic Temperature (°C)
Time Frame
up to day 100 (EOS)
Title
Vital Signs: Oxygen Saturation (SpO2%)
Time Frame
up to day 100 (EOS)
Title
Cardiac Safety assessed by 12-lead Electrocardiogram (ECG)
Time Frame
up to day 100 (EOS)
Title
Physical Examination
Description
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.
Time Frame
up to day 100 (EOS)
Title
Number of subjects with Laboratory Abnormalities
Time Frame
up to day 100 (EOS)
Title
Assessment of local tolerability
Description
Number of subjects with reaction at the injection site. The injection site is assessed for any pain, tenderness, erythema and induration.
Time Frame
up to day 100 (EOS)
Title
Number of subjects with Adverse Events
Time Frame
up to day 100 (EOS)
Secondary Outcome Measure Information:
Title
Observed maximum concentration (Cmax)
Description
The maximum observed concentration (Cmax) is estimated based on the serum concentrations.
Time Frame
up to day 100 (EOS)
Title
Time to Cmax (Tmax)
Time Frame
up to day 100 (EOS)
Title
The area under the serum concentration-time curve (AUC)
Time Frame
up to day 100 (EOS)
Title
Apparent total body clearance of the drug from plasma (CL)
Time Frame
up to day 100 (EOS)
Title
The apparent volume of distribution during terminal phase after drug administration (Vz)
Time Frame
up to day 100 (EOS)
Title
Terminal Elimination Half-Life (T½)
Time Frame
up to day 100 (EOS)
Title
Proportion of subjects with treatment-emergent anti-drug antibodies (ADA)
Time Frame
up to day 100 (EOS)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
HMR
City
London
ZIP/Postal Code
NW10 7EW
Country
United Kingdom
12. IPD Sharing Statement
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Safety, Tolerability and PK of Ensovibep (MP0420 - a New Candidate With Potential for Treatment of COVID-19)
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