Covid19Phase 1NCT04941183
Phase 1 Study to Assess Safety, Tolerability, PD, PK, Immunogenicity of IV NTR-441 Solution in Healthy Volunteers and COVID-19 Patients
A Phase 1 study testing NTR-441 in people with Covid19, run by Neutrolis at 4 sites in 2 countries.
Trial summary
This first-in-human clinical study is a Phase 1a/ 1b, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and PK/PD of NTR-441 in healthy subjects and patients with COVID-19 after single ascending IV infusion doses and multiple ascending IV infusion doses. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- NTR-441
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 14 Apr 2021to 6 Jun 2023
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, non-smoker, ≥18 and ≤55 years of age, with Body Mass Index (BMI) > 18.5 and < 32.0 kg/m2
- Healthy with no clinically significant findings, determined by medical evaluation (medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations) at Screening
- Subject is able to understand and is willing to comply with all study requirements, and willing to follow the instructions of the study staff.
- Subject voluntarily agrees to participate in this study.
- Male or female, non-smoker, ≥18 years of age.
- Participant has active laboratory-confirmed SARS-CoV-2 infection.
- Participant must be hospitalized for COVID-19 pneumonia.
- Ability to provide informed consent personally, or by a legally acceptable representative if the participant is unable to do so.
Who cannot join
- Pregnancy, nursing, and/or breastfeeding.
- Study participant has a history of an anaphylactic reaction.
- Subject has used an investigational drug within 30 days (or 5 half-lives whichever is longer) prior to the first dose of study drug.
- Has received any prescription or nonprescription over-the-counter (except occasional use of acetaminophen, paracetamol or ibuprofen) medication, topical medications, vitamins, dietary or herbal during the last 14 days or 5 half-lives, whichever is longer.
- Subject has a positive urine test for drugs of abuse at the screening visit or admission.
- Regular consumption of alcohol within 6 months prior to Screening or use of illicit substances within 3 months prior to screening.
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- Subject has positive test for SARS-CoV-2 infection, human immunodeficiency virus (HIV), chronic or active hepatitis B, or active hepatitis C.
- Donation or loss of blood or plasma within 4 weeks prior to initial dosing.
- Subject has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, mental or other medical disorder, including cirrhosis or malignancy; a history of a psychiatric disorder that will affect the subject's ability to participate in the study.
- Subject has a clinically relevant abnormal ECG; abnormal laboratory values.
- Subject has hypertension.
- COVID-19 patients:
- Pregnancy, nursing, and/or breastfeeding.
- History of an anaphylactic reaction.
- In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
- Severely immune-compromised participants.
- Participant known to test positive for human immunodeficiency virus (HIV), chronic or active hepatitis B, or active hepatitis C.
- Any other clinical conditions that in the opinion of the Investigator would make the participants unsuitable for the study.
- Prior treatment with any investigational drug therapy against coronavirus infection within 5 half-lives, prior to enrollment
- Participants who have received an experimental (or, in future, potentially a licensed) immunization or remdesivir against coronavirus remain eligible.
- Participation in another clinical study with the study intervention administered from 30 days or 5 half-lives whichever is longer.
- Anticipated transfer to another hospital which is not a study site during the intervention period.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Austria2 sites
Klinik Favoriten
Vienna
Medical University Vienna, Department of Clinical Pharmacology
Vienna
Ukraine2 sites
Kyiv City Clinical Hospital#1
Kyiv
Vinnytsa City Clinical Hospital # 1
Vinnytsia
About this study
Official title: A Randomized, Placebo-controlled, Double-blind, Single-ascending-dose and Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of IV NTR-441 Solution in HV Adults and COVID-19 Patients
This first-in-human clinical study is a Phase 1a/ 1b, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and PK/PD of NTR-441 in healthy subjects and patients with COVID-19 after single ascending IV infusion doses and multiple ascending IV infusion doses.
- Conditions
- Covid19
- Being tested
- NTR-441, Placebo
- Keywords
- Covid 19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTR-441Drug
NTR-441
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| NTR-441 | Experimental | Single Ascending Dose; Multiple Ascending Dose. Receives: Drug: NTR-441 |
| Placebo | Placebo comparator | Single Ascending Dose; Multiple Ascending Dose. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety and tolerability of single and multiple ascending doses of NTR-441 solution administered intravenously (IV) to adults
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 following a single or multiple IV of NTR-441.
Measured: 60 days
Secondary outcomes (8)
Measurement of maximum plasma concentration (Cmax)
Maximum plasma concentration
Measured: 15 days
Measurement of time of maximum plasma concentration (Tmax)
Time of maximum plasma concentration
Measured: 14 days
Measurement of area under the concentration-time curve
Area under the concentration-time curve from predose to the time of the last quantifiable concentration
Measured: 15 days
Measurement of the terminal elimination rate (λz)
Terminal elimination rate
Measured: 15 days
Measurement of terminal elimination half-life (t½)
Terminal elimination half-life
Measured: 15 days
Measurement of total body clearance (CL/F)
Total body clearance
Measured: 15 days
Measurement of apparent volume of distribution
Apparent volume of distribution
Measured: 15 days
To assess for immunogenicity of NTR-441 following single ascending and multiples ascending doses of NTR-441 solution administered IV to adults
Concentration of anti-drug antibodies of NTR-441 following single and multiples doses of NTR-441 solution administered IV
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start14 Apr 2021
- Primary completion12 Dec 2022
- Study completion6 Jun 2023
Why it stopped: the emergence of the omicron variant of COVID-19 lead to insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomized, placebo-controlled, double-blind, single-ascending-dose and multiple-ascending-dose
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neutrolis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941183
- Sponsor's protocol ID
- NTR441-1001
- Status last verified
- Jan 2024
- First submitted
- 4 May 2021
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Single-ascending-dose and Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of IV NTR-441 Solution in HV Adults and COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04941183
- Acronym / sponsor ID
- NTR441-1001
- Conditions
- Covid19
- Keywords
- Covid 19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the emergence of the omicron variant of COVID-19 lead to insufficient enrollment
- Enrolment
- 52 participants (actual)
- Lead sponsor
- NeutrolisIndustry (pharma, biotech, devices)
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 12 Dec 2022 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 28 Jun 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 first-in-human clinical study is a Phase 1a/ 1b, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and PK/PD of NTR-441 in healthy subjects and patients with COVID-19 after single ascending IV infusion doses and multiple ascending IV infusion doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomized, placebo-controlled, double-blind, single-ascending-dose and multiple-ascending-dose
| Arm | Type | Receives |
|---|---|---|
| NTR-441 | Experimental | Drug: NTR-441Single Ascending Dose; Multiple Ascending Dose. |
| Placebo | Placebo comparator | Drug: PlaceboSingle Ascending Dose; Multiple Ascending Dose. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, non-smoker, ≥18 and ≤55 years of age, with Body Mass Index (BMI) > 18.5 and < 32.0 kg/m2
- Healthy with no clinically significant findings, determined by medical evaluation (medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations) at Screening
- Subject is able to understand and is willing to comply with all study requirements, and willing to follow the instructions of the study staff.
- Subject voluntarily agrees to participate in this study.
- Male or female, non-smoker, ≥18 years of age.
Key exclusion criteria (22 listed)
- Pregnancy, nursing, and/or breastfeeding.
- Study participant has a history of an anaphylactic reaction.
- Subject has used an investigational drug within 30 days (or 5 half-lives whichever is longer) prior to the first dose of study drug.
- Has received any prescription or nonprescription over-the-counter (except occasional use of acetaminophen, paracetamol or ibuprofen) medication, topical medications, vitamins, dietary or herbal during the last 14 days or 5 half-lives, whichever is longer.
- Subject has a positive urine test for drugs of abuse at the screening visit or admission.
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 |
|---|---|---|
| NTR-441NTR-441 | Drug | NTR-441 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
To evaluate safety and tolerability of single and multiple ascending doses of NTR-441 solution administered intravenously (IV) to adults
Time frame: 60 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 following a single or multiple IV of NTR-441.
8 secondary outcomes
Measurement of maximum plasma concentration (Cmax)
Time frame: 15 days
Measurement of time of maximum plasma concentration (Tmax)
Time frame: 14 days
Measurement of area under the concentration-time curve
Time frame: 15 days
Measurement of the terminal elimination rate (λz)
Time frame: 15 days
Measurement of terminal elimination half-life (t½)
Time frame: 15 days
Measurement of total body clearance (CL/F)
Time frame: 15 days
Measurement of apparent volume of distribution
Time frame: 15 days
To assess for immunogenicity of NTR-441 following single ascending and multiples ascending doses of NTR-441 solution administered IV to adults
Time frame: 30 days
Results and safety
The study was stopped early (reason given: the emergence of the omicron variant of COVID-19 lead to insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
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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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NTR-441 in people with Covid19, run by Neutrolis at 4 sites in 2 countries.
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 8 inclusion and 22 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 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Austria, Ukraine. 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: the emergence of the omicron variant of COVID-19 lead to insufficient enrollment). 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?
To evaluate safety and tolerability of single and multiple ascending doses of NTR-441 solution administered intravenously (IV) to adults (time frame: 60 days). 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 19 Jan 2024.