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


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

Full Title of Study: “A Phase 1, Randomised, Double-blind, Placebo-controlled, First-time-in-human Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered MP0420 (a Novel Drug Candidate With Potential for Treatment of COVID-19) in Healthy Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Other
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: July 2021


  • Drug: Ensovibep
    • The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohort. 3 cohorts are planned. One administration at day 1 by infusion.
  • Drug: Placebo
    • One administration at day 1 by infusion.

Arms, Groups and Cohorts

  • Experimental: ensovibep dose 1
  • Experimental: ensovibep dose 2
  • Experimental: ensovibep dose 3

Clinical Trial Outcome Measures

Primary Measures

  • Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)
    • Time Frame: up to day 100 (EOS)
  • Vital Signs: Heart Rate (bmp)
    • Time Frame: up to day 100 (EOS)
  • Vital Signs: Tympanic Temperature (°C)
    • Time Frame: up to day 100 (EOS)
  • Vital Signs: Oxygen Saturation (SpO2%)
    • Time Frame: up to day 100 (EOS)
  • Cardiac Safety assessed by 12-lead Electrocardiogram (ECG)
    • Time Frame: up to day 100 (EOS)
  • Physical Examination
    • Time Frame: 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
    • Time Frame: up to day 100 (EOS)
  • Assessment of local tolerability
    • Time Frame: 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
    • Time Frame: up to day 100 (EOS)

Secondary Measures

  • Observed maximum concentration (Cmax)
    • Time Frame: up to day 100 (EOS)
    • The maximum observed concentration (Cmax) is estimated based on the serum concentrations.
  • Time to Cmax (Tmax)
    • Time Frame: up to day 100 (EOS)
  • The area under the serum concentration-time curve (AUC)
    • Time Frame: up to day 100 (EOS)
  • Apparent total body clearance of the drug from plasma (CL)
    • Time Frame: up to day 100 (EOS)
  • The apparent volume of distribution during terminal phase after drug administration (Vz)
    • Time Frame: up to day 100 (EOS)
  • Terminal Elimination Half-Life (T½)
    • Time Frame: up to day 100 (EOS)
  • Proportion of subjects with treatment-emergent anti-drug antibodies (ADA)
    • Time Frame: up to day 100 (EOS)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Molecular Partners AG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Medical Director MPAG, +41 44 755 77 00,

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