Covid19-associated ARDSPhase 1NCT04737486

A First-in-Human Study of AV-001 in Healthy Subjects

A Phase 1 study testing AV-001 in people with Covid19-associated ARDS and Covid19, run by Vasomune Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Phase 1 randomized, double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) first-in-human study in healthy subjects. Safety and tolerability assessments will be conducted, and blood samples will be taken pre-dose and at several time points post-dose for pharmacokinetic (PK) and… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Covid19-associated ARDS, Covid19, ARDS
What is being tested?: AV-001
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteUnited States
Study dates: 16 Dec 2020to 10 Mar 2021
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

Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) approved informed consent prior to performing any of the Screening Visit procedures
Males and female subjects of nonchildbearing potential between 18 to 65 years of age, inclusive, at the Screening Visit
Male subjects must agree to use a highly effective form of contraception (e.g., abstinence, double-barrier methods, have had a vasectomy or have sexual partner(s) of nonchildbearing potential) at the time of the Screening Visit and for 30 days after the dose or last dose of IMP. Male subjects must also agree to not donate sperm for the duration of the study and until 90 days after the dose or last dose of IMP
Female subjects must be nonpregnant and nonlactating and either surgically sterile (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or postmenopausal for > 12 months. Postmenopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels ≥ 40 U/mL at the Screening Visit for amenorrheic female subjects
Non smokers (or other nicotine use) as determined by history (no nicotine use over the past three months) and by negative urine cotinine concentration at the Screening Visit and admission
Body weight > 50 kg and <150 kg at the Screening Visit

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Body mass index (BMI) between 19 and 32 kg/m2, inclusive, at the Screening Visit
Vital sign measurements at the Screening Visit and on Day 1 within the following ranges (measurements may be repeated once per the discretion of the Principal Investigator):
Systolic blood pressure: 110 to 139 mmHg
Diastolic blood pressure: 70 to 89 mmHg
Pulse rate: 40 to 90 bpm
Oral body temperature: 35.0°C to 37.5°C A subject should not be included if their standing vital signs (relative to sitting) show findings which, in the opinion of the Principal Investigator, are associated with the clinical manifestation of postural hypotension (i.e., absence of any other cause). These changes include either a > 20 mmHg decrease in systolic, a >10 mmHg decrease in DBP, a > 30 bpm increase in heart rate from sitting to standing or > 120 bpm
Healthy, determined by prestudy medical evaluation (medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory evaluations)

Who cannot join

Subject has clinically significant history or evidence of cardiovascular, hematologic, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological or psychiatric disorder(s) as determined by the Principal Investigator or designee
Subject has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs, in the opinion of the Principal Investigator
Subject has a history of autonomic dysfunction (e.g., a history of fainting, orthostatic hypotension)
Subject has any concurrent disease or condition that, in the opinion of the Principal Investigator, would make the subject unsuitable for participation in the clinical study
Subject has history of alcohol and/or illicit drug abuse within 2 years of entry
Subject has positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV) or human immunodeficiency virus (HIV) type 1 and 2 antibodies

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Subject has positive breath alcohol test for ethanol at the Screening Visit or admission.
Subject has positive urine drug test at the Screening Visit or admission
Female subjects are breastfeeding or female subjects with a positive serum pregnancy test at the Screening Visit or admission
Subject is unwilling to avoid consumption of xanthine containing products (e.g., caffeine in coffee, tea, chocolate) within 48 hours prior to admission until discharge from the clinical site
Subject is unwilling to avoid use of alcohol or alcohol-containing foods, medications or beverages, within 48 hours prior to admission until discharge from the clinical site
Subject has donated blood (> 500 mL) or blood products within 2 months (56 days) prior to admission
Subject has used over-the-counter (OTC) medications (including vitamins), 7 days prior to admission or prescription medications or herbal remedies from 14 days prior to admission until the End-of-Study Visit. By exception, paracetamol/acetaminophen ≤ 1000 mg per day and hormonal replacement therapy are permitted
Subject has participated in a clinical study or used an investigational drug within 30 days or 5 × half lives (whichever is the longer interval) prior to the Screening Visit
Subject is unwilling to abstain from vigorous exercise from 48 hours prior to admission until the End of Study Visit
Subject has a history of hypersensitivity to the study drug or any of the excipients or to medicinal products with similar chemical structures or containing PEG (i.e., GripaNait® cough syrup, Betadine® antiseptic solution/cream)
Subject is unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope and possible consequences of the clinical study
Subject is unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits and improbability of completing the clinical study
Subject has a positive test result for SARS-CoV-2 before randomization
Subject has previously been enrolled in this clinical study
Vulnerable subjects defined as individuals whose willingness to volunteer in a clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g., persons in detention, minors and those incapable of giving consent)

Trial locations and contacts

1 site in 1 country.

United States1 site

Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, 45227

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase 1 Single and Multiple-Dose Pharmacokinetic First-in-Human Study of AV-001 in Healthy Subjects

Read the detailed description

In the SAD segment of the study, up to 4 ascending cohorts of 8 healthy subjects each will receive a single dose of study drug (AV-001 or placebo) in a sequential ascending manner. Planned doses may be adapted depending on emergent safety, tolerability and available PK data. Screening evaluations will occur from Day -28 to Day -2. Eligible subjects will be admitted to the clinical unit on Day -2. On Day 1, subjects will be randomized to AV-001 (6 subjects) or placebo (2 subjects) and receive a single dose of study drug. Subjects will be discharged on Day 2 after all post dose assessments have been completed and if there are no medical reasons for a longer stay in the clinical unit. An end of study visit will be conducted 7 to 10 days after Day 1 or at early termination.

An initial sentinel group consisting of 1 subject receiving AV-001 and 1 subject receiving placebo will proceed for each cohort prior to treatment of the remainder of the cohort. After study drug administration to the sentinel group and an appropriate safety interval (at least 24 hours and per the discretion of the Principal Investigator (PI)), the remaining 5 subjects will receive a single dose of AV-001 and 1 subject will receive placebo administered in the same manner.

PK blood samples will be collected at 15 time points relative to study drug dosing on Day 1. PD blood samples for will be collected at 6 time points on Day 1.

In the MAD segment of the study, up to 2 ascending cohorts of 8 subjects each will receive once daily doses of study drug (AV-001 or placebo) for at least 7 days in a sequential ascending manner. Planned doses may be adapted and will be determined by the safety, tolerability and PK data from the SAD part of the study. Screening evaluations will occur from Day -28 to Day -2. Eligible subjects will be admitted to the clinical unit on Day -2. On Day 1, subjects will be randomized to AV-001 (6 subjects) or placebo (2 subjects). Subjects will receive once-daily doses of study drug from Day 1 through Day 7. Subjects will be discharged on Day 8 after all post dose assessments have been completed and if there are no medical reasons for a longer stay in the clinical unit. An end of study visit will be conducted 7 to 10 days after Day 7 or at early termination.

PK blood samples will be collected at 15 time points relative to study drug dosing on Day 1 and Day 7 in addition to predose levels on Days 2 to 6. PD blood samples for will be collected at 6 time points on Day 1 and Day 7.

Conditions: Covid19-associated ARDS, Covid19, ARDS
Being tested: AV-001, Placebo
Keywords: Vascular normalization, Endothelial stability
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AV-001Drug
AV-001 (mpaBr) Cl for Injection 2.5 mg/mL
PlaceboOther
D-PBS

Study groups in NCT04737486
Study group	Role	What they receive
Single Ascending Dose Cohort 1-4	Experimental	Intervention: AV-001, 6 subjects per cohort will receive single doses of 1.4 µg/kg up to 56 µg/kg of AV-001 by intravenous bolus injection. Receives: Drug: AV-001
Single Ascending Dose Cohort 1-4, Placebo	Placebo comparator	Intervention: Placebo, 2 subjects per cohort will receive single doses of D-PBS placebo by intravenous bolus injection. Receives: Other: Placebo
Multiple Ascending Dose Cohort 1-2	Experimental	Intervention: AV-001, 6 subjects per cohort will receive multiple doses of 1.4 µg/kg/day up to 56 µg/kg/day of AV-001 daily for 7 consecutive days by intravenous bolus injection. Receives: Drug: AV-001
Multiple Ascending Dose Cohort 1-2, Placebo	Placebo comparator	Intervention: Placebo, 2 subjects per cohort will receive multiple doses of D-PBS placebo daily for 7 consecutive days by intravenous bolus injection. Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Participants experiencing drug-related adverse events
Number of drug-related adverse events as determined by abnormal clinical laboratory tests, vitals signs, continuous blood pressure monitoring and collection (systolic, diastolic, pulse pressure, heart rate and mean arterial pressure), physical exam and ECG parameters
Measured: 8 days following a single intravenous dose (SAD) or 8 days following 7 consecutive daily intravenous doses (MAD)

Secondary outcomes (12)

Cmax: Maximum plasma AV-001 concentration
Maximum plasma AV-001 concentration
Measured: 1 day following a single intravenous dose (SAD); 8 days following 7 consecutive daily intravenous doses (MAD)
Tmax: Time of maximum plasma AV-001 concentration
Time of maximum plasma AV-001 concentration
Measured: 1 day following a single intravenous dose (SAD); 8 days ollowing 7 consecutive daily intravenous doses (MAD)
AUClast: AUC from predose (time 0) to the time of the last quantifiable concentration
AUC from predose (time 0) to the time of the last quantifiable concentration
Measured: 1 day following a single intravenous dose (SAD); 8 days following 7 consecutive daily intravenous doses (MAD)
AUCinf: AUC from predose (time 0) extrapolated to infinite time
AUC from predose (time 0) extrapolated to infinite time
Measured: 1 day following a single intravenous dose (SAD); 1 day following first daily intravenous dose (MAD)
AUCtau: AUC over the dose interval time
AUC over the dose interval time
Measured: 8 days following 7 consecutive daily intravenous doses (MAD)
λz: The terminal elimination rate
The terminal elimination rate
Measured: 1 day following a single intravenous dose (SAD); 8 days following 7 consecutive daily intravenous doses (MAD)
T½: Terminal elimination half-life
Terminal elimination half-life
Measured: 1 day following a single intravenous dose (SAD); 8 days following 7 consecutive daily intravenous doses (MAD)
CL: Total body clearance
Total body clearance
Measured: 1 day following single intravenous dose (SAD); 8 days following 7 consecutive daily intravenous doses (MAD)
Vz: Apparent volume of distribution
Apparent volume of distribution
Measured: 1 day following a single intravenous dose (SAD); 8 days following 7 consecutive daily intravenous doses (MAD)
Ctau: Trough plasma concentration
Trough plasma concentration
Measured: 6 days (day 2 through day 6 of daily intravenous doses) (MAD)
Rac(AUCtau), Rac(Cmax), Rac(Ctau): Accumulation ratios assessment
Accumulation ratios assessment
Measured: 8 days following 7 consecutive daily intravenous doses (MAD)
LM: Time-invariance ratio calculation
Time-invariance ratio calculation
Measured: 8 days following 7 consecutive daily intravenous doses (MAD)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 202010 Mar 2021

First posted3 Feb 2021 (estimated)
Study start16 Dec 2020
Primary completion10 Mar 2021
Study completion10 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Covid19-associated ARDSStudies 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: Single and multiple ascending dose
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04737486
Sponsor's protocol ID: AV001-PK-001
Status last verified: Jan 2021
First submitted: 31 Dec 2020
Last updated: 24 Mar 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Phase 1 Single and Multiple-Dose Pharmacokinetic First-in-Human Study of AV-001 in Healthy Subjects
ClinicalTrials.gov ID: NCT04737486
Acronym / sponsor ID: AV001-PK-001
Conditions: Covid19-associated ARDS, Covid19, ARDS
Keywords: Vascular normalization, Endothelial stability
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Vasomune Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 16 Dec 2020 (actual)
Primary completion: 10 Mar 2021 (actual)
Study completion: 10 Mar 2021 (actual)
First posted: 3 Feb 2021 (estimated)
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.

Detailed description

PK blood samples will be collected at 15 time points relative to study drug dosing on Day 1. PD blood samples for will be collected at 6 time points on Day 1.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Single and multiple ascending dose

Arm	Type	Receives
Single Ascending Dose Cohort 1-4	Experimental	Drug: AV-001Intervention: AV-001, 6 subjects per cohort will receive single doses of 1.4 µg/kg up to 56 µg/kg of AV-001 by intravenous bolus injection.
Single Ascending Dose Cohort 1-4, Placebo	Placebo comparator	Other: PlaceboIntervention: Placebo, 2 subjects per cohort will receive single doses of D-PBS placebo by intravenous bolus injection.
Multiple Ascending Dose Cohort 1-2	Experimental	Drug: AV-001Intervention: AV-001, 6 subjects per cohort will receive multiple doses of 1.4 µg/kg/day up to 56 µg/kg/day of AV-001 daily for 7 consecutive days by intravenous bolus injection.
Multiple Ascending Dose Cohort 1-2, Placebo	Placebo comparator	Other: PlaceboIntervention: Placebo, 2 subjects per cohort will receive multiple doses of D-PBS placebo daily for 7 consecutive days by intravenous bolus injection.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Subject voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) approved informed consent prior to performing any of the Screening Visit procedures
Males and female subjects of nonchildbearing potential between 18 to 65 years of age, inclusive, at the Screening Visit
Male subjects must agree to use a highly effective form of contraception (e.g., abstinence, double-barrier methods, have had a vasectomy or have sexual partner(s) of nonchildbearing potential) at the time of the Screening Visit and for 30 days after the dose or last dose of IMP. Male subjects must also agree to not donate sperm for the duration of the study and until 90 days after the dose or last dose of IMP
Female subjects must be nonpregnant and nonlactating and either surgically sterile (e.g., bilateral tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or postmenopausal for > 12 months. Postmenopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels ≥ 40 U/mL at the Screening Visit for amenorrheic female subjects
Non smokers (or other nicotine use) as determined by history (no nicotine use over the past three months) and by negative urine cotinine concentration at the Screening Visit and admission

Key exclusion criteria (21 listed)

Subject has clinically significant history or evidence of cardiovascular, hematologic, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological or psychiatric disorder(s) as determined by the Principal Investigator or designee
Subject has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs, in the opinion of the Principal Investigator
Subject has a history of autonomic dysfunction (e.g., a history of fainting, orthostatic hypotension)
Subject has any concurrent disease or condition that, in the opinion of the Principal Investigator, would make the subject unsuitable for participation in the clinical study
Subject has history of alcohol and/or illicit drug abuse within 2 years of entry

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
AV-001AV-001 (mpaBr) Cl for Injection 2.5 mg/mL	Drug	Multiple Ascending Dose Cohort 1-2, Single Ascending Dose Cohort 1-4
PlaceboD-PBS	Other	Multiple Ascending Dose Cohort 1-2, Placebo, Single Ascending Dose Cohort 1-4, Placebo

Primary outcome

Participants experiencing drug-related adverse events
Time frame: 8 days following a single intravenous dose (SAD) or 8 days following 7 consecutive daily intravenous doses (MAD)
Number of drug-related adverse events as determined by abnormal clinical laboratory tests, vitals signs, continuous blood pressure monitoring and collection (systolic, diastolic, pulse pressure, heart rate and mean arterial pressure), physical exam and ECG parameters

12 secondary outcomes

Cmax: Maximum plasma AV-001 concentration
Time frame: 1 day following a single intravenous dose (SAD); 8 days following 7 consecutive daily intravenous doses (MAD)
Tmax: Time of maximum plasma AV-001 concentration
Time frame: 1 day following a single intravenous dose (SAD); 8 days ollowing 7 consecutive daily intravenous doses (MAD)
AUClast: AUC from predose (time 0) to the time of the last quantifiable concentration
Time frame: 1 day following a single intravenous dose (SAD); 8 days following 7 consecutive daily intravenous doses (MAD)
AUCinf: AUC from predose (time 0) extrapolated to infinite time
Time frame: 1 day following a single intravenous dose (SAD); 1 day following first daily intravenous dose (MAD)
AUCtau: AUC over the dose interval time
Time frame: 8 days following 7 consecutive daily intravenous doses (MAD)
λz: The terminal elimination rate
Time frame: 1 day following a single intravenous dose (SAD); 8 days following 7 consecutive daily intravenous doses (MAD)
T½: Terminal elimination half-life
Time frame: 1 day following a single intravenous dose (SAD); 8 days following 7 consecutive daily intravenous doses (MAD)
CL: Total body clearance
Time frame: 1 day following single intravenous dose (SAD); 8 days following 7 consecutive daily intravenous doses (MAD)
Vz: Apparent volume of distribution
Time frame: 1 day following a single intravenous dose (SAD); 8 days following 7 consecutive daily intravenous doses (MAD)
Ctau: Trough plasma concentration
Time frame: 6 days (day 2 through day 6 of daily intravenous doses) (MAD)
Rac(AUCtau), Rac(Cmax), Rac(Ctau): Accumulation ratios assessment
Time frame: 8 days following 7 consecutive daily intravenous doses (MAD)
LM: Time-invariance ratio calculation
Time frame: 8 days following 7 consecutive daily intravenous doses (MAD)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.

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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.

Leela Vrishabhendra, MD principal investigator

Medpace, Inc.

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 AV-001 in people with Covid19-associated ARDS and Covid19, run by Vasomune Therapeutics, Inc. at 1 site in United States.

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 13 inclusion and 21 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: finished, as of the sponsor's last update on 24 Mar 2021. 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 States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Participants experiencing drug-related adverse events (time frame: 8 days following a single intravenous dose (SAD) or 8 days following 7 consecutive daily intravenous doses (MAD)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04737486.

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 24 Mar 2021.