COVID-19
Conditions
Keywords
ensovibep, COVID-19 treatment, SARS-CoV-2, Corona, designed ankyrin repeat protein (DARPin®), angiotensin-converting enzyme 2 (ACE2)
Brief summary
This study will investigate how ensovibep is distributed throughout the body, the safety and the tolerability of ensovibep in healthy volunteers
Interventions
DRUGEnsovibep
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.
DRUGPlacebo
One administration at day 1 by infusion.
Sponsors
Molecular Partners AG
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Part A only
Intervention model description
Parallel (Part A) Sequential (Part B and Part C)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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) | — |
| Number of subjects with Adverse Events | up to day 100 (EOS) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| 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) | — |
Countries
United Kingdom
Outcome results
None listed