COVID-19Phase 1NCT04870164
Safety, Tolerability and PK of Ensovibep (MP0420 - a New Candidate With Potential for Treatment of COVID-19)
A Phase 1 study testing Ensovibep in people with COVID-19, run by Molecular Partners AG at 1 site in United Kingdom.
Trial summary
This study will investigate how ensovibep is distributed throughout the body, the safety and the tolerability of ensovibep in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Ensovibep
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Nov 2020to 6 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
This study will investigate how ensovibep is distributed throughout the body, the safety and the tolerability of ensovibep in healthy volunteers
- Conditions
- COVID-19
- Being tested
- Ensovibep, Placebo
- Keywords
- ensovibep, COVID-19 treatment, SARS-CoV-2, Corona, designed ankyrin repeat protein (DARPin®), angiotensin-converting enzyme 2 (ACE2)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnsovibepDrug
Also called MP0420, DARPin, COVID-19 treatment
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.
PlaceboDrug
One administration at day 1 by infusion.
| Study group | Role | What they receive |
|---|---|---|
| ensovibep dose 1 (infusion) | Experimental | Not described Receives: Drug: Ensovibep |
| ensovibep dose 2 (infusion) | Experimental | Not described Receives: Drug: Ensovibep |
| ensovibep dose 3 (infusion) | Experimental | Not described Receives: Drug: Ensovibep |
| placebo (infusion) | Placebo comparator | Not described Receives: Drug: Placebo |
| ensovibep dose 4 (IV bolus) | Experimental | Not described Receives: Drug: Ensovibep |
| ensovibep dose 5 (IV bolus) | Experimental | Not described Receives: Drug: Ensovibep |
| ensovibep dose 6 (SC injection) | Experimental | Not described Receives: Drug: Ensovibep |
| ensovibep dose 7 (SC injection) | Experimental | Not described Receives: Drug: Ensovibep |
| ensovibep dose 8 (SC injection) | Experimental | Not described Receives: Drug: Ensovibep |
| ensovibep dose 9 (SC injection) | Experimental | Not described Receives: Drug: Ensovibep |
| ensovibep dose 10 (IM injection) | Experimental | Not described Receives: Drug: Ensovibep |
| ensovibep dose 11 (IM injection) | Experimental | Not described Receives: Drug: Ensovibep |
| ensovibep dose 12 (IM injection) | Experimental | Not described Receives: Drug: Ensovibep |
| ensovibep dose 13 (IM injection) | Experimental | Not described Receives: Drug: Ensovibep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)
Measured: up to day 100 (EOS)
Vital Signs: Heart Rate (bmp)
Measured: up to day 100 (EOS)
Vital Signs: Tympanic Temperature (°C)
Measured: up to day 100 (EOS)
Vital Signs: Oxygen Saturation (SpO2%)
Measured: up to day 100 (EOS)
Cardiac Safety assessed by 12-lead Electrocardiogram (ECG)
Measured: 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.
Measured: up to day 100 (EOS)
Number of subjects with Laboratory Abnormalities
Measured: 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.
Measured: up to day 100 (EOS)
Number of subjects with Adverse Events
Measured: up to day 100 (EOS)
Secondary outcomes (7)
Observed maximum concentration (Cmax)
The maximum observed concentration (Cmax) is estimated based on the serum concentrations.
Measured: up to day 100 (EOS)
Time to Cmax (Tmax)
Measured: up to day 100 (EOS)
The area under the serum concentration-time curve (AUC)
Measured: up to day 100 (EOS)
Apparent total body clearance of the drug from plasma (CL)
Measured: up to day 100 (EOS)
The apparent volume of distribution during terminal phase after drug administration (Vz)
Measured: up to day 100 (EOS)
Terminal Elimination Half-Life (T½)
Measured: up to day 100 (EOS)
Proportion of subjects with treatment-emergent anti-drug antibodies (ADA)
Measured: up to day 100 (EOS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start18 Nov 2020
- Primary completion6 Jan 2022
- Study completion6 Jan 2022
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Parallel (Part A) Sequential (Part B and Part C)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molecular Partners AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870164
- Sponsor's protocol ID
- MP0420-CP101
- Other IDs
- 2020-004365-39
- Status last verified
- Mar 2022
- First submitted
- 28 Apr 2021
- Last updated
- 18 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04870164
- Acronym / sponsor ID
- MP0420-CP101
- Conditions
- COVID-19
- Keywords
- ensovibep, COVID-19 treatment, SARS-CoV-2, Corona, designed ankyrin repeat protein (DARPin®), angiotensin-converting enzyme 2 (ACE2)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Molecular Partners AGIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 6 Jan 2022 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate how ensovibep is distributed throughout the body, the safety and the tolerability of ensovibep in healthy volunteers
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
- Model description
- Parallel (Part A) Sequential (Part B and Part C)
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnsovibepAlso: MP0420, DARPin, COVID-19 treatmentThe 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. | Drug | 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) |
| PlaceboOne administration at day 1 by infusion. | Drug | placebo (infusion) |
Primary outcome
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)
7 secondary outcomes
Observed maximum concentration (Cmax)
Time frame: up to day 100 (EOS)
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)
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ensovibep in people with COVID-19, run by Molecular Partners AG at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital Signs: Blood Pressure Systolic and Diastolic (mmHg) (time frame: up to day 100 (EOS)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.