Clinical trial NCT04870164: Safety, Tolerability and PK of Ensovibep (MP0420 - a New Candidate With Potential for Treatment of COVID-19)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: COVID-19
Keywords: ensovibep
COVID-19 treatment
SARS-CoV-2
Corona
designed ankyrin repeat protein (DARPin®)
angiotensin-converting enzyme 2 (ACE2)
Lead sponsor: Molecular Partners AG
Sponsor class: INDUSTRY
First posted: 2021-05-03
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Parallel (Part A) Sequential (Part B and Part C)
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)
timeFrame: up to day 100 (EOS)
measure: Vital Signs: Heart Rate (bmp)
timeFrame: up to day 100 (EOS)
measure: Vital Signs: Tympanic Temperature (°C)
timeFrame: up to day 100 (EOS)
measure: Vital Signs: Oxygen Saturation (SpO2%)
timeFrame: up to day 100 (EOS)
measure: Cardiac Safety assessed by 12-lead Electrocardiogram (ECG)
timeFrame: up to day 100 (EOS)
measure: Physical Examination
timeFrame: up to day 100 (EOS)
measure: Number of subjects with Laboratory Abnormalities
timeFrame: up to day 100 (EOS)
measure: Assessment of local tolerability
timeFrame: up to day 100 (EOS)
measure: Number of subjects with Adverse Events
timeFrame: up to day 100 (EOS)
Secondary outcomes:
measure: Observed maximum concentration (Cmax)
timeFrame: up to day 100 (EOS)
measure: Time to Cmax (Tmax)
timeFrame: up to day 100 (EOS)
measure: The area under the serum concentration-time curve (AUC)
timeFrame: up to day 100 (EOS)
measure: Apparent total body clearance of the drug from plasma (CL)
timeFrame: up to day 100 (EOS)
measure: The apparent volume of distribution during terminal phase after drug administration (Vz)
timeFrame: up to day 100 (EOS)
measure: Terminal Elimination Half-Life (T½)
timeFrame: up to day 100 (EOS)
measure: Proportion of subjects with treatment-emergent anti-drug antibodies (ADA)
timeFrame: up to day 100 (EOS)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: HMR
Study officials:
References: