Safety, Tolerability and PK of Ensovibep (MP0420)

Overview

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

Interventions

  • 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, info@molecularpartners.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.