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

Phase 1

Terminated

• Conditions: COVID-19
• Interventions: Drug: Ensovibep; Drug: Placebo

• Registration Number: NCT04870164
• Lead Sponsor: Molecular Partners AG

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-18
• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-05-03
• Primary Completion: 2022-01-06
• Study Completion: 2022-01-06
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-03
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 53

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ensovibep dose 1 (infusion)	Ensovibep	-
ensovibep dose 2 (infusion)	Ensovibep	-
ensovibep dose 3 (infusion)	Ensovibep	-
placebo (infusion)	Placebo	-
ensovibep dose 4 (IV bolus)	Ensovibep	-
ensovibep dose 5 (IV bolus)	Ensovibep	-
ensovibep dose 6 (SC injection)	Ensovibep	-
ensovibep dose 7 (SC injection)	Ensovibep	-
ensovibep dose 8 (SC injection)	Ensovibep	-
ensovibep dose 9 (SC injection)	Ensovibep	-
ensovibep dose 10 (IM injection)	Ensovibep	-
ensovibep dose 11 (IM injection)	Ensovibep	-
ensovibep dose 12 (IM injection)	Ensovibep	-
ensovibep dose 13 (IM injection)	Ensovibep	-

Primary Outcome Measures

Name	Time	Method
Vital Signs: Heart Rate (bmp)	up to day 100 (EOS)
Vital Signs: Oxygen Saturation (SpO2%)	up to day 100 (EOS)
Vital Signs: Tympanic Temperature (°C)	up to day 100 (EOS)
Number of subjects with Laboratory Abnormalities	up to day 100 (EOS)
Cardiac Safety assessed by 12-lead Electrocardiogram (ECG)	up to day 100 (EOS)
Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)	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.
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

Name	Time	Method
Time to Cmax (Tmax)	up to day 100 (EOS)
The area under the serum concentration-time curve (AUC)	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.
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)

Trial Locations

Locations (1)

HMR; 🇬🇧 London, United Kingdom