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

COVID-19 Clinical Trial

Official title:

A Phase 1, First-time-in-human, Dose Ascending Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MP0420 (a Novel Drug Candidate With Potential for Treatment of COVID-19) in Healthy Volunteers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04870164
• Other study ID #: MP0420-CP101
• Secondary ID: 2020-004365-39
• Status: Terminated
• Phase: Phase 1
• Start date: November 18, 2020
• Est. completion date: January 6, 2022

Study information

• Verified date: March 2022
• Source: Molecular Partners AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: January 6, 2022
• Est. primary completion date: January 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Ensovibep
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.
• Placebo
One administration at day 1 by infusion.

Locations

Country	Name	City	State
United Kingdom	HMR	London

Sponsors (1)

Lead Sponsor	Collaborator
Molecular Partners AG

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)		up to day 100 (EOS)
Primary	Vital Signs: Heart Rate (bmp)		up to day 100 (EOS)
Primary	Vital Signs: Tympanic Temperature (°C)		up to day 100 (EOS)
Primary	Vital Signs: Oxygen Saturation (SpO2%)		up to day 100 (EOS)
Primary	Cardiac Safety assessed by 12-lead Electrocardiogram (ECG)		up to day 100 (EOS)
Primary	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)
Primary	Number of subjects with Laboratory Abnormalities		up to day 100 (EOS)
Primary	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)
Primary	Number of subjects with Adverse Events		up to day 100 (EOS)
Secondary	Observed maximum concentration (Cmax)	The maximum observed concentration (Cmax) is estimated based on the serum concentrations.	up to day 100 (EOS)
Secondary	Time to Cmax (Tmax)		up to day 100 (EOS)
Secondary	The area under the serum concentration-time curve (AUC)		up to day 100 (EOS)
Secondary	Apparent total body clearance of the drug from plasma (CL)		up to day 100 (EOS)
Secondary	The apparent volume of distribution during terminal phase after drug administration (Vz)		up to day 100 (EOS)
Secondary	Terminal Elimination Half-Life (T½)		up to day 100 (EOS)
Secondary	Proportion of subjects with treatment-emergent anti-drug antibodies (ADA)		up to day 100 (EOS)