Healthy VolunteersPhase 1NCT05291546
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 in Healthy Adult Volunteers and Mildly Hypertensive Participants
A Phase 1 study testing REGN9035 and REGN5381 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 2 sites in 2 countries.
Trial summary
The primary objective of the study is to: Evaluate the safety and tolerability of REGN5381 and REGN9035 administered alone or sequentially. The secondary objectives of the study are to: Evaluate the ability of single intravenous (IV) doses of REGN9035 (compared to placebo) to reverse the acute hemodynamic effects of… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- REGN9035 and REGN5381
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Apr 2022to 2 Apr 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 18 and 32 kg/m2, inclusive, at the screening visit.
- Normal or mildly elevated blood pressure as defined in the protocol.
Who cannot join
- History of unexplained syncope or autonomic dysfunction.
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.
- Protocol-defined risk factors for cardiovascular disease.
- Note: Other protocol defined inclusion / exclusion criteria apply
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Belgium1 site
Universitair Ziekenhuis Leuven Gasthuisberg Campus
Leuven, B-3000
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 (an Anti-REGN5381 Antibody and Reversal Agent) and REGN5381 (an NPR1 Agonist Antibody) When Administered Alone or in Sequence to Healthy Volunteers and Mildly Hypertensive Subjects
The primary objective of the study is to:
- Evaluate the safety and tolerability of REGN5381 and REGN9035 administered alone or sequentially.
The secondary objectives of the study are to:
- Evaluate the ability of single intravenous (IV) doses of REGN9035 (compared to placebo) to reverse the acute hemodynamic effects of REGN5381
- Evaluate the hemodynamic effects of single IV doses of REGN5381
- Evaluate the persistence of the hemodynamic effects of single IV doses of REGN5381 and the reversal of REGN5381 effects by REGN9035 (compared to placebo)
- Evaluate the pharmacokinetics of single IV doses of REGN5381 and REGN9035 administered alone or sequentially
- Conditions
- Healthy Volunteers
- Being tested
- REGN9035, REGN5381, Placebo
- Keywords
- Healthy Volunteers, Mild Hypertension, High Blood Pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN9035Drug
Part A: Single dose administered by IV infusion on day 1. Part B: Selected doses administered by IV infusion on day 2 or 22.
REGN5381Drug
Part B: Selected doses administered by IV infusion on day 1.
PlaceboOther
Part A: Single dose administered by IV infusion on day1. Part B: Single dose administered by IV infusion on day 1, day 2 and/or day 22.
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Single ascending dose (SAD) of REGN9035 or matching placebo given by intravenous (IV) administration. Receives: Drug: REGN9035; Other: Placebo |
| Part B | Experimental | Selected doses of REGN5381 or matching placebo given by IV administration followed by selected doses of REGN9035 and/or matching placebo via IV infusion Receives: Drug: REGN9035; Drug: REGN5381; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Measured: Up to Day 162
Secondary outcomes (90)
Mean systolic blood pressure (SBP) obtained after study drug administration
Up to 24 hours after study drug administration.
Measured: Up to Day 3
Mean diastolic blood pressure (DBP) obtained after study drug administration
Measured: Up to Day 3
Mean arterial pressure (MAP) obtained after study drug administration
Measured: Up to Day 3
Mean pulse pressure (PP) obtained after study drug administration
Measured: Up to Day 3
Mean pulse rate (PR) obtained after study drug administration
Measured: Up to Day 3
Mean stroke volume (SV) obtained after study drug administration
Measured: Up to Day 3
Absolute change in the mean SBP obtained after study drug administration
Measured: Up to Day 3
Absolute change in the mean DBP obtained after study drug administration
Measured: Up to Day 3
Absolute change in the mean MAP obtained after study drug administration
Measured: Up to Day 3
Absolute change in the mean PP obtained after study drug administration
Measured: Up to Day 3
Absolute change in the mean PR obtained after study drug administration
Measured: Up to Day 3
Absolute change in the mean SV obtained after study drug administration
Measured: Up to Day 3
Maximum change in the mean SBP obtained after study drug administration
Measured: Up to Day 3
Maximum change in the mean DBP obtained after study drug administration
Measured: Up to Day 3
Maximum change in the mean MAP obtained after study drug administration
Measured: Up to Day 3
Maximum change in the mean PP obtained after study drug administration
Measured: Up to Day 3
Maximum change in the mean PR obtained after study drug administration
Measured: Up to Day 3
Maximum change in the mean SV obtained after study drug administration
Measured: Up to Day 3
Percent change in the mean SBP obtained after study drug administration
Measured: Up to Day 3
Percent change in the mean DBP obtained after study drug administration
Measured: Up to Day 3
Percent change in the mean MAP obtained after study drug administration
Measured: Up to Day 3
Percent change in the mean PP obtained after study drug administration
Measured: Up to Day 3
Percent change in the mean PR obtained after study drug administration
Measured: Up to Day 3
Percent change in the mean SV obtained after study drug administration
Measured: Up to Day 3
Absolute change from baseline (post-REGN5381 administration) in the mean SBP obtained after study drug administration
Measured: Up to Day 3
Absolute change from baseline (post-REGN5381 administration) in the mean DBP obtained after study drug administration
Measured: Up to Day 3
Absolute change from baseline (post-REGN5381 administration) in the mean MAP obtained after study drug administration
Measured: Up to Day 3
Absolute change from baseline (post-REGN5381 administration) in the mean PP obtained after study drug administration
Measured: Up to Day 3
Absolute change from baseline (post-REGN5381 administration) in the mean PR obtained after study drug administration
Measured: Up to Day 3
Absolute change from baseline (post-REGN5381 administration) in the mean SV obtained after study drug administration
Measured: Up to Day 3
Maximum change from baseline (post-REGN administration) in the mean SBP obtained after study drug administration
Measured: Up to Day 3
Maximum change from baseline (post-REGN administration) in the mean DBP obtained after study drug administration
Measured: Up to Day 3
Maximum change from baseline (post-REGN administration) in the mean MAP obtained after study drug administration
Measured: Up to Day 3
Maximum change from baseline (post-REGN administration) in the mean PP obtained after study drug administration
Measured: Up to Day 3
Maximum change from baseline (post-REN5381 administration) in the mean PR obtained after study drug administration
Measured: Up to Day 3
Maximum change from baseline (post-REGN5381 administration) in the mean SV obtained after study drug administration
Measured: Up to Day 3
Percent change from baseline (post-REN5381 administration) in the mean SBP obtained after study drug administration
Measured: Up to Day 3
Percent change from baseline (post-REN5381 administration) in the mean DBP obtained after study drug administration
Measured: Up to Day 3
Percent change from baseline (post-REN5381 administration) in the mean MAP obtained after study drug administration
Measured: Up to Day 3
Percent change from baseline (post-REN5381 administration) in the mean PP obtained after study drug administration
Measured: Up to Day 3
Percent change from baseline (post-REN5381 administration) in the mean PR obtained after study drug administration
Measured: Up to Day 3
Percent change from baseline (post-REN5381 administration) in the mean SV obtained after study drug administration
Measured: Up to Day 3
Absolute change from baseline (pre-REGN5381 administration) in the mean SBP obtained after study drug administration
Measured: Up to Day 3
Absolute change from baseline (pre-REGN5381 administration) in the mean DBP obtained after study drug administration
Measured: Up to Day 3
Absolute change from baseline (pre-REGN5381 administration) in the mean MAP obtained after study drug administration
Measured: Up to Day 3
Absolute change from baseline (pre-REGN5381 administration) in the mean PP obtained after study drug administration
Measured: Up to Day 3
Absolute change from baseline (pre-REGN5381 administration) in the mean PR obtained after study drug administration
Measured: Up to Day 3
Absolute change from baseline (pre-REGN5381 administration) in the mean SV obtained after study drug administration
Measured: Up to Day 3
Maximum change from baseline (pre-REGN administration) in the mean SBP obtained after study drug administration
Measured: Up to Day 3
Maximum change from baseline (pre-REGN administration) in the mean DBP obtained after study drug administration
Measured: Up to Day 3
Maximum change from baseline (pre-REGN administration) in the mean MAP obtained after study drug administration
Measured: Up to Day 3
Maximum change from baseline (pre-REGN administration) in the mean PP obtained after study drug administration
Measured: Up to Day 3
Maximum change from baseline (pre-REGN administration) in the mean PR obtained after study drug administration
Measured: Up to Day 3
Maximum change from baseline (pre-REGN administration) in the mean SV obtained after study drug administration
Measured: Up to Day 3
Percent change from baseline (pre-REN5381 administration) in the mean SBP obtained after study drug administration
Measured: Up to Day 3
Percent change from baseline (pre-REN5381 administration) in the mean DBP obtained after study drug administration
Measured: Up to Day 3
Percent change from baseline (pre-REN5381 administration) in the mean MAP obtained after study drug administration
Measured: Up to Day 3
Percent change from baseline (pre-REN5381 administration) in the mean PP obtained after study drug administration
Measured: Up to Day 3
Percent change from baseline (pre-REN5381 administration) in the mean PR obtained after study drug administration
Measured: Up to Day 3
Percent change from baseline (pre-REN5381 administration) in the mean SV obtained after study drug administration
Measured: Up to Day 3
Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) SBP obtained after study drug administration.
Measured: Baseline to Day 3
Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) DBP obtained after study drug administration.
Measured: Baseline to Day 3
Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) MAP obtained after study drug administration.
Measured: Baseline to Day 3
Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) PP obtained after study drug administration.
Measured: Baseline to Day 3
Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) PR obtained after study drug administration.
Measured: Baseline to Day 3
Percentage of participants who return to within 10% of baseline (pre-REGN5381 administration) SV obtained after study drug administration.
Measured: Baseline to Day 3
Time to return to within 10% of baseline (pre-REGN5381) SBP
Measured: Up to approximately Day 162
Time to return to within 10% of baseline (pre-REGN5381) DBP
Measured: Up to approximately Day 162
Time to return to within 10% of baseline (pre-REGN5381) MAP
Measured: Up to approximately Day 162
Time to return to within 10% of baseline (pre-REGN5381) PP
Measured: Up to approximately Day 162
Time to return to within 10% of baseline (pre-REGN5381) PR
Measured: Up to approximately Day 162
Time to return to within 10% of baseline (pre-REGN5381) SV
Measured: Up to approximately Day 162
SBP
Measured: Through Day 36
DBP
Measured: Through Day 36
MAP
Measured: Through Day 36
PP
Measured: Through Day 36
PR
Measured: Through Day 36
Absolute change from baseline in SBP
Measured: Through Day 36
Absolute change from baseline in DBP
Measured: Through Day 36
Absolute change from baseline in MAP
Measured: Through Day 36
Absolute change from baseline in PP
Measured: Through Day 36
Absolute change from baseline in PR
Measured: Through Day 36
Percent change from baseline in SBP
Measured: Through Day 36
Percent change from baseline in DBP
Measured: Through Day 36
Percent change from baseline in MAP
Measured: Through Day 36
Percent change from baseline in PP
Measured: Through Day 36
Percent change from baseline in PR
Measured: Through Day 36
Concentrations of total REGN9035
Measured: Up to Day 162
Concentrations of total REGN5381 over time
Measured: Up to Day 162
Concentrations of total REGN9035 and/or total REGN5381
Measured: Up to Day 162
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start13 Apr 2022
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291546
- Sponsor's protocol ID
- R9035-HV-2125
- Other IDs
- 2021-005174-26
- Status last verified
- Apr 2024
- First submitted
- 28 Feb 2022
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN9035 (an Anti-REGN5381 Antibody and Reversal Agent) and REGN5381 (an NPR1 Agonist Antibody) When Administered Alone or in Sequence to Healthy Volunteers and Mildly Hypertensive Subjects
- ClinicalTrials.gov ID
- NCT05291546
- Acronym / sponsor ID
- R9035-HV-2125
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers, Mild Hypertension, High Blood Pressure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 22 Mar 2022 (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.
The primary objective of the study is to:
- Evaluate the safety and tolerability of REGN5381 and REGN9035 administered alone or sequentially.
The secondary objectives of the study are to:
- Evaluate the ability of single intravenous (IV) doses of REGN9035 (compared to placebo) to reverse the acute hemodynamic effects of REGN5381
- Evaluate the hemodynamic effects of single IV doses of REGN5381
- Evaluate the persistence of the hemodynamic effects of single IV doses of REGN5381 and the reversal of REGN5381 effects by REGN9035 (compared to placebo)
- Evaluate the pharmacokinetics of single IV doses of REGN5381 and REGN9035 administered alone or sequentially
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: REGN9035, Other: PlaceboSingle ascending dose (SAD) of REGN9035 or matching placebo given by intravenous (IV) administration. |
| Part B | Experimental | Drug: REGN9035, Drug: REGN5381, Other: PlaceboSelected doses of REGN5381 or matching placebo given by IV administration followed by selected doses of REGN9035 and/or matching placebo via IV infusion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) between 18 and 32 kg/m2, inclusive, at the screening visit.
- Normal or mildly elevated blood pressure as defined in the protocol.
Key exclusion criteria (4 listed)
- History of unexplained syncope or autonomic dysfunction.
- History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease.
- Protocol-defined risk factors for cardiovascular disease.
- Note: Other protocol defined inclusion / exclusion criteria apply
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 |
|---|---|---|
| REGN9035Part A: Single dose administered by IV infusion on day 1. Part B: Selected doses administered by IV infusion on day 2 or 22. | Drug | Part A, Part B |
| REGN5381Part B: Selected doses administered by IV infusion on day 1. | Drug | Part B |
| PlaceboPart A: Single dose administered by IV infusion on day1. Part B: Single dose administered by IV infusion on day 1, day 2 and/or day 22. | Other | Part A, Part B |
Primary outcome
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Day 162
90 secondary outcomes
Mean systolic blood pressure (SBP) obtained after study drug administration
Time frame: Up to Day 3
Mean diastolic blood pressure (DBP) obtained after study drug administration
Time frame: Up to Day 3
Mean arterial pressure (MAP) obtained after study drug administration
Time frame: Up to Day 3
Mean pulse pressure (PP) obtained after study drug administration
Time frame: Up to Day 3
Mean pulse rate (PR) obtained after study drug administration
Time frame: Up to Day 3
Mean stroke volume (SV) obtained after study drug administration
Time frame: Up to Day 3
Absolute change in the mean SBP obtained after study drug administration
Time frame: Up to Day 3
Absolute change in the mean DBP obtained after study drug administration
Time frame: Up to Day 3
Absolute change in the mean MAP obtained after study drug administration
Time frame: Up to Day 3
Absolute change in the mean PP obtained after study drug administration
Time frame: Up to Day 3
Absolute change in the mean PR obtained after study drug administration
Time frame: Up to Day 3
Absolute change in the mean SV obtained after study drug administration
Time frame: Up to Day 3
Maximum change in the mean SBP obtained after study drug administration
Time frame: Up to Day 3
Maximum change in the mean DBP obtained after study drug administration
Time frame: Up to Day 3
Maximum change in the mean MAP obtained after study drug administration
Time frame: Up to Day 3
Maximum change in the mean PP obtained after study drug administration
Time frame: Up to Day 3
Maximum change in the mean PR obtained after study drug administration
Time frame: Up to Day 3
Maximum change in the mean SV obtained after study drug administration
Time frame: Up to Day 3
Percent change in the mean SBP obtained after study drug administration
Time frame: Up to Day 3
Percent change in the mean DBP obtained after study drug administration
Time frame: Up to Day 3
Percent change in the mean MAP obtained after study drug administration
Time frame: Up to Day 3
Percent change in the mean PP obtained after study drug administration
Time frame: Up to Day 3
Percent change in the mean PR obtained after study drug administration
Time frame: Up to Day 3
Percent change in the mean SV obtained after study drug administration
Time frame: Up to Day 3
Absolute change from baseline (post-REGN5381 administration) in the mean SBP obtained after study drug administration
Time frame: Up to Day 3
Absolute change from baseline (post-REGN5381 administration) in the mean DBP obtained after study drug administration
Time frame: Up to Day 3
Absolute change from baseline (post-REGN5381 administration) in the mean MAP obtained after study drug administration
Time frame: Up to Day 3
Absolute change from baseline (post-REGN5381 administration) in the mean PP obtained after study drug administration
Time frame: Up to Day 3
Absolute change from baseline (post-REGN5381 administration) in the mean PR obtained after study drug administration
Time frame: Up to Day 3
Absolute change from baseline (post-REGN5381 administration) in the mean SV obtained after study drug administration
Time frame: Up to Day 3
Maximum change from baseline (post-REGN administration) in the mean SBP obtained after study drug administration
Time frame: Up to Day 3
Maximum change from baseline (post-REGN administration) in the mean DBP obtained after study drug administration
Time frame: Up to Day 3
Maximum change from baseline (post-REGN administration) in the mean MAP obtained after study drug administration
Time frame: Up to Day 3
Maximum change from baseline (post-REGN administration) in the mean PP obtained after study drug administration
Time frame: Up to Day 3
Maximum change from baseline (post-REN5381 administration) in the mean PR obtained after study drug administration
Time frame: Up to Day 3
Maximum change from baseline (post-REGN5381 administration) in the mean SV obtained after study drug administration
Time frame: Up to Day 3
Percent change from baseline (post-REN5381 administration) in the mean SBP obtained after study drug administration
Time frame: Up to Day 3
Percent change from baseline (post-REN5381 administration) in the mean DBP obtained after study drug administration
Time frame: Up to Day 3
Percent change from baseline (post-REN5381 administration) in the mean MAP obtained after study drug administration
Time frame: Up to Day 3
Percent change from baseline (post-REN5381 administration) in the mean PP obtained after study drug administration
Time frame: Up to Day 3
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 15 Apr 2024.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Screening Protocol
Pain
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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
2 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 REGN9035 and REGN5381 in people with Healthy Volunteers, run by Regeneron Pharmaceuticals at 2 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 2 inclusion and 4 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 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, Germany. 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. 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?
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs) (time frame: Up to Day 162). 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 15 Apr 2024.