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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004365-39 | EudraCT Number |
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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.
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This study will investigate how ensovibep is distributed throughout the body, the safety and the tolerability of ensovibep in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ensovibep dose 1 (infusion) | Experimental |
| |
| ensovibep dose 2 (infusion) | Experimental |
| |
| ensovibep dose 3 (infusion) | Experimental |
| |
| placebo (infusion) | Placebo Comparator |
| |
| ensovibep dose 4 (IV bolus) | Experimental |
| |
| ensovibep dose 5 (IV bolus) | Experimental |
| |
| ensovibep dose 6 (SC injection) | Experimental |
| |
| ensovibep dose 7 (SC injection) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ensovibep | Drug | 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HMR | London | NW10 7EW | United Kingdom |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000715987 | ensovibep |
| D000090922 | Designed Ankyrin Repeat Proteins |
| D000093485 | COVID-19 Drug Treatment |
| ID | Term |
|---|---|
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D040761 | Biomimetic Materials |
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Parallel (Part A) Sequential (Part B and Part C)
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Part A only
| Experimental |
|
| ensovibep dose 8 (SC injection) | Experimental |
|
| ensovibep dose 9 (SC injection) | Experimental |
|
| ensovibep dose 10 (IM injection) | Experimental |
|
| ensovibep dose 11 (IM injection) | Experimental |
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| ensovibep dose 12 (IM injection) | Experimental |
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| ensovibep dose 13 (IM injection) | Experimental |
|
|
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| Placebo | Drug | One administration at day 1 by infusion. |
|
| 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) |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008420 |
| Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |