Alzheimers DiseasePhase 1NCT04023994
A Single Ascending Dose Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Intravenously Administered RO7126209 in Healthy Participants
A Phase 1 study testing RO7126209 in people with Alzheimers Disease, run by Hoffmann-La Roche at 1 site in United States.
Trial summary
Study BP41192 is a randomized, adaptive, placebo-controlled parallel group study to investigate the safety, tolerability, immunogenicity and pharmacokinetics of single-ascending intravenous (IV) doses of RO7126209 in healthy participants. RO7126209 is being developed for the treatment of Alzheimer's Disease. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alzheimers Disease
- What is being tested?
- RO7126209
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2019to 17 Jul 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, ophthalmologic examination, hematology, blood chemistry, coagulation, serology, and urinalysis.
- Body mass index (BMI) of 18-30 kg/m2 inclusive
- During the treatment period and until the final follow up visit, agreement to: (1) Remain abstinent or use contraceptive measures such as a condom plus an additional contraceptive method that together result in a failure rate of <1% per year, with a partner who is a woman of childbearing potential. (2) With pregnant female partner, remain abstinent or use contraceptive measures such as a condom to avoid exposing the embryo. (3) Refrain from donating sperm from Day 1 of the study until 90 days after last dose.
Who cannot join
- Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study.
- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, ophthalmologic, hematological or allergic disease, metabolic disorder, cancer or cirrhosis.
- Any suspicion or history of alcohol abuse and/or suspicion of regular consumption of drug of abuse within the last 5 years.
- Positive result on hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 and 2.
- History or presence of clinically significant ECG abnormalities or cardiovascular disease.
- Clinically-significant abnormalities in laboratory test results.
Show all 19Show fewer
- Any major illness within one month before the screening examination or any febrile illness within one week prior to screening and up to first dose administration.
- Impaired hepatic function as indicated by screening aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >=1.5 x the upper limit of normal (ULN) or abnormal total bilirubin unless due to Gilbert's disease.
- Any clinically relevant history of hypersensitivity or allergic reactions, either spontaneous or following drug administration, or exposure to foods or environmental agents.
- History of hypersensitivity to biologic agents or any of the excipients in the formulation.
- History of raised intra-cerebral pressure or vertebral joint pathology
- Use of prohibited medication or herbal remedies as described in the section of concomitant medications
- Prior administration of gantenerumab (RO4909832)
- Any vaccination within two months prior to Day 1
- Participation in an investigational drug medicinal product or medical device study within 30 days before screening or within seven times the elimination half-life if known, whichever is longer.
- Participants who regularly smoke more than 5 cigarettes daily or equivalent and are unable or unwilling not to smoke during the in-house period.
- Donation or loss of blood over 500 mL within three months prior to Day 1 and donation of blood for the duration of the study until follow-up.
- Evidence of clinically significant brain magnetic resonance imaging (MRI) findings, including lacunar infarct, territorial infarct or macroscopic hemorrhage, microbleed or area of leptomeningeal hemosiderosis, or deep white matter lesions corresponding to an overall Fazekas score of ≥ 2.
- Claustrophobia, presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or body that would contraindicate an MRI scan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomized, Adaptive, Investigator/Subject Blind, Single Ascending Dose, Placebo-Controlled Phase I Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Intravenously Administered RO7126209 in Healthy Participants
Study BP41192 is a randomized, adaptive, placebo-controlled parallel group study to investigate the safety, tolerability, immunogenicity and pharmacokinetics of single-ascending intravenous (IV) doses of RO7126209 in healthy participants. RO7126209 is being developed for the treatment of Alzheimer's Disease.
Read the detailed description
This study uses a parallel group design, with participants recruited in 5 planned sequential cohorts. Additional cohort(s) may be added if dose escalation stopping criteria are not met after cohort 5. Participants will receive a single IV dose of either RO7126209 or placebo. RO7126209 doses will be administered in ascending order. After the starting dose, subsequent doses will be selected in an adaptive manner during study conduct based on emerging safety, tolerability and PK data.
- Conditions
- Alzheimers Disease
- Being tested
- RO7126209, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7126209Drug
Participants will be administered single-ascending intravenous doses of RO7126209 with at least 2 weeks between each dose level. After the starting dose, the subsequent doses will be selected in an adaptive design. Sentinel dosing will be employed.
PlaceboDrug
Participants will be administered a single intravenous dose of matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | In Cohorts 1-5, there were ten participants in total who received placebo, two in each cohort. Receives: Drug: Placebo |
| RO7126209 (0.1 mg/kg) | Experimental | Healthy volunteers will be administered a single intravenous dose of RO7126209 (0.1 mg/kg). Receives: Drug: RO7126209 |
| RO7126209 (0.4 mg/kg) | Experimental | Healthy volunteers will be administered a single intravenous dose of RO7126209 (0.4 mg/kg). Receives: Drug: RO7126209 |
| RO7126209 (1.2 mg/kg) | Experimental | Healthy volunteers will be administered a single intravenous dose of RO7126209 (1.2 mg/kg). Receives: Drug: RO7126209 |
| RO7126209 (3.6 mg/kg) | Experimental | Healthy volunteers will be administered a single intravenous dose of RO7126209 (3.6 mg/kg). Receives: Drug: RO7126209 |
| RO7126209 (7.2 mg/kg) | Experimental | Healthy volunteers will be administered a single intravenous dose of RO7126209 (7.2 mg/kg). Receives: Drug: RO7126209 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs)
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events.
Measured: Up to approximately 9 weeks
Secondary outcomes (11)
Concentration at the End of Infusion (Cend) of RO7126209
Plasma concentrations of RO7126209 were measured by a specific and validated assay at specified timepoints. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below.
Measured: Day 1
Area Under the Plasma Concentration Versus Time Curve From Zero to 24 h Postdose (AUC0-24h) of RO7126209
Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below.
Measured: Days 1 and 2
Area Under the Plasma Concentration Versus Time Curve From Zero to 168h Postdose (AUC0-168h) of RO7126209
Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below.
Measured: Days 1, 2, 3, 4, 5 and 8
Area Under the Plasma Concentration Versus Time Curve From Zero to the Last Measurable Concentration (AUC0-last) of RO7126209
Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below.
Measured: Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf)
Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below.
Measured: Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57
Terminal Rate Constant (Lambda z) of RO7126209
Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below.
Measured: Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57
Apparent Terminal Half-Life (T1/2) of RO7126209
Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below.
Measured: Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57
Total Body Clearance Calculated as Dose/AUC (CL) of RO7126209
Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below.
Measured: Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57
Volume of Distribution at Steady-State (Vss) of RO7126209
Plasma concentrations of RO7126209 were measured by a specific and validated assay. Plasma PK parameters of RO7126209 were read directly from the plasma concentration versus time profiles or calculated by using standard non-compartmental methods. Geometric Mean and Coefficient of Variation data are presented below.
Measured: Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57
Cerebrospinal Fluid (CSF) Concentration of RO7126209
RO7126209 CSF concentrations were measured by a specific and validated method. Geometric Mean and Coefficient of Variation data are presented below.
Measured: Day 3 and Day 5
Percentage of Participants With Anti-RO7126209 Antibodies (ADAs)
The numbers and proportions of Anti-Drug Antibody (ADA) positive participants and ADA negative participants at baseline (baseline prevalence) and after study drug administration (post-baseline incidence during both the treatment and follow-up periods) were summarized per dose group during both the treatment and follow-up period.
Measured: Days 1, 8, 29 and 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start3 Aug 2019
- Primary completion17 Jul 2020
- Study completion17 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimers DiseaseStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04023994
- Sponsor's protocol ID
- BP41192
- Status last verified
- Jul 2021
- First submitted
- 16 Jul 2019
- Last updated
- 9 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Publications
Muliaditan M, van Steeg TJ, Avery LB, Sun W, Hammond TR, Hijdra D, Choi SL, Pillai N, Leksa NC, Mavroudis PD. Translational minimal physiologically based pharmacokinetic model for transferrin receptor-mediated brain delivery of antibodies. MAbs. 2025 Dec;17(1):2515414. doi: 10.1080/19420862.2025.2515414. Epub 2025 Jun 26.
PubMed 40568753
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Adaptive, Investigator/Subject Blind, Single Ascending Dose, Placebo-Controlled Phase I Study to Investigate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Intravenously Administered RO7126209 in Healthy Participants
- ClinicalTrials.gov ID
- NCT04023994
- Acronym / sponsor ID
- BP41192
- Conditions
- Alzheimers Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2019 (actual)
- Primary completion
- 17 Jul 2020 (actual)
- Study completion
- 17 Jul 2020 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Posted 9 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study BP41192 is a randomized, adaptive, placebo-controlled parallel group study to investigate the safety, tolerability, immunogenicity and pharmacokinetics of single-ascending intravenous (IV) doses of RO7126209 in healthy participants. RO7126209 is being developed for the treatment of Alzheimer's Disease.
Detailed description
This study uses a parallel group design, with participants recruited in 5 planned sequential cohorts. Additional cohort(s) may be added if dose escalation stopping criteria are not met after cohort 5. Participants will receive a single IV dose of either RO7126209 or placebo. RO7126209 doses will be administered in ascending order. After the starting dose, subsequent doses will be selected in an adaptive manner during study conduct based on emerging safety, tolerability and PK data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboIn Cohorts 1-5, there were ten participants in total who received placebo, two in each cohort. |
| RO7126209 (0.1 mg/kg) | Experimental | Drug: RO7126209Healthy volunteers will be administered a single intravenous dose of RO7126209 (0.1 mg/kg). |
| RO7126209 (0.4 mg/kg) | Experimental | Drug: RO7126209Healthy volunteers will be administered a single intravenous dose of RO7126209 (0.4 mg/kg). |
| RO7126209 (1.2 mg/kg) | Experimental | Drug: RO7126209Healthy volunteers will be administered a single intravenous dose of RO7126209 (1.2 mg/kg). |
| RO7126209 (3.6 mg/kg) | Experimental | Drug: RO7126209Healthy volunteers will be administered a single intravenous dose of RO7126209 (3.6 mg/kg). |
| RO7126209 (7.2 mg/kg) | Experimental | Drug: RO7126209Healthy volunteers will be administered a single intravenous dose of RO7126209 (7.2 mg/kg). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy status is defined by the absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, ophthalmologic examination, hematology, blood chemistry, coagulation, serology, and urinalysis.
- Body mass index (BMI) of 18-30 kg/m2 inclusive
- During the treatment period and until the final follow up visit, agreement to: (1) Remain abstinent or use contraceptive measures such as a condom plus an additional contraceptive method that together result in a failure rate of <1% per year, with a partner who is a woman of childbearing potential. (2) With pregnant female partner, remain abstinent or use contraceptive measures such as a condom to avoid exposing the embryo. (3) Refrain from donating sperm from Day 1 of the study until 90 days after last dose.
Key exclusion criteria (19 listed)
- Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study.
- History of any clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological, ophthalmologic, hematological or allergic disease, metabolic disorder, cancer or cirrhosis.
- Any suspicion or history of alcohol abuse and/or suspicion of regular consumption of drug of abuse within the last 5 years.
- Positive result on hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 and 2.
- History or presence of clinically significant ECG abnormalities or cardiovascular disease.
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 |
|---|---|---|
| RO7126209Participants will be administered single-ascending intravenous doses of RO7126209 with at least 2 weeks between each dose level. After the starting dose, the subsequent doses will be selected in an adaptive design. Sentinel dosing will be employed. | Drug | RO7126209 (0.1 mg/kg), RO7126209 (0.4 mg/kg), RO7126209 (1.2 mg/kg), RO7126209 (3.6 mg/kg), RO7126209 (7.2 mg/kg) |
| PlaceboParticipants will be administered a single intravenous dose of matching placebo. | Drug | Placebo |
Primary outcome
Percentage of Participants With Adverse Events (AEs)
Time frame: Up to approximately 9 weeks
An Adverse Event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An Adverse Event can therefore be any unfavorable and unintended sign (including abnormal laboratory values or abnormal clinical test results), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as Adverse Events.
11 secondary outcomes
Concentration at the End of Infusion (Cend) of RO7126209
Time frame: Day 1
Area Under the Plasma Concentration Versus Time Curve From Zero to 24 h Postdose (AUC0-24h) of RO7126209
Time frame: Days 1 and 2
Area Under the Plasma Concentration Versus Time Curve From Zero to 168h Postdose (AUC0-168h) of RO7126209
Time frame: Days 1, 2, 3, 4, 5 and 8
Area Under the Plasma Concentration Versus Time Curve From Zero to the Last Measurable Concentration (AUC0-last) of RO7126209
Time frame: Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57
Area Under the Plasma Concentration Versus Time Curve Extrapolated to Infinity (AUC0-inf)
Time frame: Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57
Terminal Rate Constant (Lambda z) of RO7126209
Time frame: Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57
Apparent Terminal Half-Life (T1/2) of RO7126209
Time frame: Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57
Total Body Clearance Calculated as Dose/AUC (CL) of RO7126209
Time frame: Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57
Volume of Distribution at Steady-State (Vss) of RO7126209
Time frame: Days 1, 2, 3, 4, 5, 8, 10, 15, 22, 29, 43 and 57
Cerebrospinal Fluid (CSF) Concentration of RO7126209
Time frame: Day 3 and Day 5
Percentage of Participants With Anti-RO7126209 Antibodies (ADAs)
Time frame: Days 1, 8, 29 and 57
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40568753Muliaditan M, van Steeg TJ, Avery LB, Sun W, Hammond TR, Hijdra D, Choi SL, Pillai N, Leksa NC, Mavroudis PD. Translational minimal physiologically based pharmacokinetic model for transferrin receptor-mediated brain delivery of antibodies. MAbs. 2025 Dec;17(1):2515414. doi: 10.1080/19420862.2025.2515414. Epub 2025 Jun 26.
- Individual participant dataSharing planned: No. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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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.
Clinical Trials study director
Hoffmann-La Roche
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 RO7126209 in people with Alzheimers Disease, run by Hoffmann-La Roche 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 3 inclusion and 19 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 9 Aug 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?
Yes. Results are posted in the registry (first posted 9 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Adverse Events (AEs) (time frame: Up to approximately 9 weeks). 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 NCT04023994, which also lists 1 linked publication.
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 9 Aug 2021.