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

NCT04870164 | Terminated Phase 1

• 2 other identifiers: MP0420-CP1012020-004365-39
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Keywords

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

Outcome Measures

Primary Outcomes (9)

• 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)

Secondary Outcomes (7)

• Observed maximum concentration (Cmax)

  up to day 100 (EOS)

• Time to Cmax (Tmax)

  up to day 100 (EOS)

• 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)

Study Arms (14)

ensovibep dose 1 (infusion)

EXPERIMENTAL

Drug: Ensovibep

ensovibep dose 2 (infusion)

EXPERIMENTAL

Drug: Ensovibep

ensovibep dose 3 (infusion)

EXPERIMENTAL

Drug: Ensovibep

placebo (infusion)

PLACEBO COMPARATOR

Drug: Placebo

ensovibep dose 4 (IV bolus)

EXPERIMENTAL

Drug: Ensovibep

ensovibep dose 5 (IV bolus)

EXPERIMENTAL

Drug: Ensovibep

ensovibep dose 6 (SC injection)

EXPERIMENTAL

Drug: Ensovibep

ensovibep dose 7 (SC injection)

EXPERIMENTAL

Drug: Ensovibep

ensovibep dose 8 (SC injection)

EXPERIMENTAL

Drug: Ensovibep

ensovibep dose 9 (SC injection)

EXPERIMENTAL

Drug: Ensovibep

ensovibep dose 10 (IM injection)

EXPERIMENTAL

Drug: Ensovibep

ensovibep dose 11 (IM injection)

EXPERIMENTAL

Drug: Ensovibep

ensovibep dose 12 (IM injection)

EXPERIMENTAL

Drug: Ensovibep

ensovibep dose 13 (IM injection)

EXPERIMENTAL

Drug: Ensovibep

Interventions

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.

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

ensovibep dose 1 (infusion); ensovibep dose 10 (IM injection); ensovibep dose 11 (IM injection); ensovibep dose 12 (IM injection); ensovibep dose 13 (IM injection); ensovibep dose 2 (infusion); ensovibep dose 3 (infusion); ensovibep dose 4 (IV bolus); ensovibep dose 5 (IV bolus); ensovibep dose 6 (SC injection); ensovibep dose 7 (SC injection); ensovibep dose 8 (SC injection); ensovibep dose 9 (SC injection)

Placebo DRUG

One administration at day 1 by infusion.

placebo (infusion)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Molecular Partners AG: lead

Study Sites (1)

HMR

London, NW10 7EW, United Kingdom

Location

MeSH Terms

Conditions

COVID-19

Interventions

ensovibep; Designed Ankyrin Repeat Proteins; COVID-19 Drug Treatment

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biomimetic Materials; Manufactured Materials; Technology, Industry, and Agriculture; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part A only
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel (Part A) Sequential (Part B and Part C)

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: November 18, 2020
• Primary Completion: January 6, 2022
• Study Completion: January 6, 2022
• Last Updated: March 18, 2022

Record last verified: 2022-03

Locations

GB (1)