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TerminatedNCT04870164Updated Mar 18, 2022

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

A Phase 1 interventional study of Ensovibep and Placebo in COVID-19, sponsored by Molecular Partners AG. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-18.

Sponsored by Molecular Partners AG · Phase 1, Interventional, and Other

Why this study was terminated
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.
Phase
Phase 1
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • COVID-19

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Keywords

  • ensovibep
  • COVID-19 treatment
  • SARS-CoV-2
  • Corona
  • designed ankyrin repeat protein (DARPin®)
  • angiotensin-converting enzyme 2 (ACE2)
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts 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

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.
04

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    ensovibep dose 1 (infusion)

    Drug: Ensovibep

  • Experimental
    ensovibep dose 2 (infusion)

    Drug: Ensovibep

  • Experimental
    ensovibep dose 3 (infusion)

    Drug: Ensovibep

  • Placebo comparator
    placebo (infusion)

    Drug: Placebo

  • Experimental
    ensovibep dose 4 (IV bolus)

    Drug: Ensovibep

  • Experimental
    ensovibep dose 5 (IV bolus)

    Drug: Ensovibep

  • Experimental
    ensovibep dose 6 (SC injection)

    Drug: Ensovibep

  • Experimental
    ensovibep dose 7 (SC injection)

    Drug: Ensovibep

  • Experimental
    ensovibep dose 8 (SC injection)

    Drug: Ensovibep

  • Experimental
    ensovibep dose 9 (SC injection)

    Drug: Ensovibep

  • Experimental
    ensovibep dose 10 (IM injection)

    Drug: Ensovibep

  • Experimental
    ensovibep dose 11 (IM injection)

    Drug: Ensovibep

  • Experimental
    ensovibep dose 12 (IM injection)

    Drug: Ensovibep

  • Experimental
    ensovibep dose 13 (IM injection)

    Drug: Ensovibep

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.

    Also known as: MP0420, DARPin, COVID-19 treatment

  • DrugPlacebo

    One administration at day 1 by infusion.

05

What researchers measure

Primary outcomes

  1. Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)

    Time frame: up to day 100 (EOS)

  2. Vital Signs: Heart Rate (bmp)

    Time frame: up to day 100 (EOS)

  3. Vital Signs: Tympanic Temperature (°C)

    Time frame: up to day 100 (EOS)

  4. Vital Signs: Oxygen Saturation (SpO2%)

    Time frame: up to day 100 (EOS)

  5. Cardiac Safety assessed by 12-lead Electrocardiogram (ECG)

    Time frame: up to day 100 (EOS)

  6. 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.

    Time frame: up to day 100 (EOS)

  7. Number of subjects with Laboratory Abnormalities

    Time frame: up to day 100 (EOS)

  8. 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.

    Time frame: up to day 100 (EOS)

  9. Number of subjects with Adverse Events

    Time frame: up to day 100 (EOS)

Secondary outcomes

  1. Observed maximum concentration (Cmax)

    The maximum observed concentration (Cmax) is estimated based on the serum concentrations.

    Time frame: up to day 100 (EOS)

  2. Time to Cmax (Tmax)

    Time frame: up to day 100 (EOS)

  3. The area under the serum concentration-time curve (AUC)

    Time frame: up to day 100 (EOS)

  4. Apparent total body clearance of the drug from plasma (CL)

    Time frame: up to day 100 (EOS)

  5. The apparent volume of distribution during terminal phase after drug administration (Vz)

    Time frame: up to day 100 (EOS)

  6. Terminal Elimination Half-Life (T½)

    Time frame: up to day 100 (EOS)

  7. Proportion of subjects with treatment-emergent anti-drug antibodies (ADA)

    Time frame: up to day 100 (EOS)

06

Study locations

1 site
  • HMR
    London, NW10 7EW, United Kingdom
07

Registry details

Key details

Study ID
NCT04870164
Lead sponsor
Molecular Partners AG
Responsible party
Sponsor
First posted
May 3, 2021
Start date
Nov 18, 2020
Primary completion
Jan 6, 2022
Completion
Jan 6, 2022
Last update
Mar 18, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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