Healthy VolunteersPhase 1NCT04593121
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BIIB107 in Healthy Adult Participants
A Phase 1 study testing BIIB107 in people with Healthy Volunteers, run by Biogen at 3 sites in United States.
Trial summary
The primary objective is to determine the safety and tolerability of single and multiple ascending subcutaneous (SC) doses and a single intravenous (IV) dose of BIIB107 in healthy adult participants. 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?
- BIIB107
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Oct 2020to 5 Mar 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
- Must have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2), inclusive, and must weigh at least 55 kilogram (kg)
- All women of childbearing potential must practice highly effective contraception during the study and for a period of 90 days, which is expected to be more than 5 half-lives of BIIB107. Men must practice effective contraception during the study and for a period of 5 half-lives of BIIB107 or 90 days after their last dose of study treatment. In addition, participants should not donate sperm or eggs during the study and for at least 5 half-lives of BIIB107 or 90 days after their last dose of study treatment
- Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction test at Screening and Check-in/admission.
Who cannot join
- History of or positive test result at Screening for human immunodeficiency virus (HIV-1/HIV-2) antibodies
- Positive test result at Screening for hepatitis C virus (HCV) antibody (Ab).
- Current hepatitis B infection (defined as per protocol) and participants with immunity to hepatitis B from previous natural infection (defined as negative hepatitis B surface antigen [HBsAg], positive hepatitis B surface antibody [HBsAb], and positive total hepatitis B core antibody [HBcAb]).
- Signs of active herpes simplex type 1 and 2 or varicella within 4 weeks prior to randomization
- Evidence of current SARS-CoV-2 infection within 4 weeks prior to Screening, at Screening, between Screening and inpatient admission (Day -1), or at admission (Day -1), including but not limited to a fever (temperature >37.5°C), new and persistent cough, breathlessness, or loss of taste or smell, per the judgement of the Investigator.
- Close contact with an individual with coronavirus disease 2019 (COVID-19) infection within 14 days prior to admission (Day -1). Close contact is defined as being within 6 feet of an infected person as confirmed via laboratory assessment for at least 15 minutes within 2 days of symptom onset (or within 2 days of specimen collection for COVID-19 testing for close contact with asymptomatic person).
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- History of tuberculosis (TB) or positive QuantiFERON® TB Gold test or, if the QuantiFERON TB Gold test is not available, a positive purified protein derivative (PPD/Mantoux test; positive PPD/Mantoux test is defined as ≥5 millimeter (mm) of induration [size of raised lump, not redness])
- John Cunningham virus (JCV) seropositivity at Screening (for potential participants enrolling in Part B)
- Ongoing or past malignancy, carcinoma in situ, or high-grade dysplasia (with the exception of no more than 1 basal cell carcinoma or squamous cell carcinoma that was completely excised and cured at least 12 months prior to randomization)
- History of severe allergic or anaphylactic reactions or history of allergic reactions that, in the opinion of the Investigator, is likely to be exacerbated by any component of the study treatment.
- Any prior exposure to mAbs, Fc-fusion proteins, or the following immunomodulator therapies per investigator judgement: natalizumab or any other anti-α4 integrin antibodies, anti-CD20, sphingosine-1-phosphate receptor modulators, or fumarate therapies.
- Any previous exposure to immunosuppressants (in particular mitoxantrone, methotrexate, azathioprine, cyclophosphamide, and mycophenolate mofetil). Any corticosteroid use should be discussed with the Sponsor prior to enrollment
- Part B only: Women of childbearing potential.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
CenExel Anaheim Clinical Trials
Anaheim, California, 92801
QPS MRA (Miami Research Associates)
Miami, Florida, 33143
Altasciences Clinical Research
Overland Park, Kansas, 66212
About this study
Official title: A Phase 1, Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Ascending-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB107 in Healthy Adult Participants
The primary objective is to determine the safety and tolerability of single and multiple ascending subcutaneous (SC) doses and a single intravenous (IV) dose of BIIB107 in healthy adult participants. The secondary objectives are to characterize the single-dose pharmacokinetic (PK) of SC and IV BIIB107 in healthy adult participants and to characterize the multiple-dose PK of SC BIIB107 in healthy adult participants.
Read the detailed description
BIIB107 is a monoclonal antibody (mAb) that targets alpha-4 integrins and is currently in development for people with multiple sclerosis.
- Conditions
- Healthy Volunteers
- Being tested
- BIIB107, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB107Drug
Administered as specified in the treatment arm.
PlaceboDrug
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1A | Experimental | Participants will receive Dose 1 of BIIB107 or placebo subcutaneous (SC) on Day 1. Receives: Drug: BIIB107; Drug: Placebo |
| Cohort 2A | Experimental | Participants will receive Dose 2 of BIIB107 or placebo SC on Day 1. Receives: Drug: BIIB107; Drug: Placebo |
| Cohort 3A | Experimental | Participants will receive Dose 3 of BIIB107 or placebo SC on Day 1. Receives: Drug: BIIB107; Drug: Placebo |
| Cohort 4A | Experimental | Participants will receive Dose 4 of BIIB107 or placebo SC on Day 1. Receives: Drug: BIIB107; Drug: Placebo |
| Cohort 7A | Experimental | Participants will receive Dose 5 of BIIB107 or placebo SC on Day 1. Receives: Drug: BIIB107; Drug: Placebo |
| Cohort 5A | Experimental | Participants will receive Dose 5 of BIIB107 or placebo intravenous (IV) on Day 1. Receives: Drug: BIIB107; Drug: Placebo |
| Cohort 8A | Experimental | Participants will receive Dose 6 of BIIB107 or placebo SC on Day 1. Receives: Drug: BIIB107; Drug: Placebo |
| Cohort 1B | Experimental | Participants will receive multiple doses of BIIB107 or placebo SC on approximately 4 dosing days. Receives: Drug: BIIB107; Drug: Placebo |
| Cohort 2B | Experimental | Participants will receive multiple doses of BIIB107 or placebo SC on approximately 4 dosing days. Receives: Drug: BIIB107; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs): Single Ascending Dose (SAD)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event.
Measured: Day -1 up to Day 84
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs): Multiple Ascending Dose (MAD)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event.
Measured: Day -1 up to Day 169
Secondary outcomes (18)
Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUCinf): SAD
Measured: Day 1 pre-dose and multiple time-points up to Day 84
Maximum Observed Concentration (Cmax): SAD
Measured: Day 1 pre-dose and multiple time-points up to Day 84
Time to Reach Maximum Observed Concentration (Tmax): SAD
Measured: Day 1 pre-dose and multiple time-points up to Day 84
Terminal Half-Life (t1/2): SAD
Measured: Day 1 pre-dose and multiple time-points up to Day 84
Clearance (CL) for IV Doses: SAD
Measured: Day 1 pre-dose and multiple time-points up to Day 84
Apparent Clearance (CL/F) of SC Doses: SAD
Measured: Day 1 pre-dose and multiple time-points up to Day 84
Volume of Distribution at Steady State (Vss) for IV Doses: SAD
Measured: Day 1 pre-dose and multiple time-points up to Day 84
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) for SC Doses: SAD
Measured: Day 1 pre-dose and multiple time-points up to Day 84
Bioavailability (F) of SC Doses: SAD
Measured: Day 1 pre-dose and multiple time-points up to Day 84
Absorption Rate Profile of SC Doses: SAD
Measured: Day 1 pre-dose and multiple time-points up to Day 84
Maximum Observed Concentration (Cmax): MAD
Measured: Day 1 pre-dose and multiple time-points up to Day 169
Time to Reach Maximum Observed Concentration (Tmax): MAD
Measured: Day 1 pre-dose and multiple time-points up to Day 169
Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau): MAD
Measured: Day 1 pre-dose and multiple time-points up to Day 169
Trough Concentration (Ctrough): MAD
Measured: Day 1 pre-dose and multiple time-points up to Day 169
Terminal Half-Life (t1/2): MAD
Measured: Day 1 pre-dose and multiple time-points up to Day 169
Accumulation Ratio (R): MAD
Measured: Day 1 pre-dose and multiple time-points up to Day 169
Apparent Clearance (CL/F) of SC Doses: MAD
Measured: Day 1 pre-dose and multiple time-points up to Day 169
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) for SC Doses: MAD
Measured: Day 1 pre-dose and multiple time-points up to Day 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start30 Oct 2020
- Primary completion5 Mar 2024
- Study completion5 Mar 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 BiogenThe 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593121
- Sponsor's protocol ID
- 271HV101
- Status last verified
- Apr 2024
- First submitted
- 13 Oct 2020
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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, Blinded, Placebo-Controlled, Single- and Multiple-Ascending-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB107 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT04593121
- Acronym / sponsor ID
- 271HV101
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 19 Oct 2020 (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 is to determine the safety and tolerability of single and multiple ascending subcutaneous (SC) doses and a single intravenous (IV) dose of BIIB107 in healthy adult participants. The secondary objectives are to characterize the single-dose pharmacokinetic (PK) of SC and IV BIIB107 in healthy adult participants and to characterize the multiple-dose PK of SC BIIB107 in healthy adult participants.
Detailed description
BIIB107 is a monoclonal antibody (mAb) that targets alpha-4 integrins and is currently in development for people with multiple sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1A | Experimental | Drug: BIIB107, Drug: PlaceboParticipants will receive Dose 1 of BIIB107 or placebo subcutaneous (SC) on Day 1. |
| Cohort 2A | Experimental | Drug: BIIB107, Drug: PlaceboParticipants will receive Dose 2 of BIIB107 or placebo SC on Day 1. |
| Cohort 3A | Experimental | Drug: BIIB107, Drug: PlaceboParticipants will receive Dose 3 of BIIB107 or placebo SC on Day 1. |
| Cohort 4A | Experimental | Drug: BIIB107, Drug: PlaceboParticipants will receive Dose 4 of BIIB107 or placebo SC on Day 1. |
| Cohort 7A | Experimental | Drug: BIIB107, Drug: PlaceboParticipants will receive Dose 5 of BIIB107 or placebo SC on Day 1. |
| Cohort 5A | Experimental | Drug: BIIB107, Drug: PlaceboParticipants will receive Dose 5 of BIIB107 or placebo intravenous (IV) on Day 1. |
| Cohort 8A | Experimental | Drug: BIIB107, Drug: PlaceboParticipants will receive Dose 6 of BIIB107 or placebo SC on Day 1. |
| Cohort 1B | Experimental | Drug: BIIB107, Drug: PlaceboParticipants will receive multiple doses of BIIB107 or placebo SC on approximately 4 dosing days. |
| Cohort 2B | Experimental | Drug: BIIB107, Drug: PlaceboParticipants will receive multiple doses of BIIB107 or placebo SC on approximately 4 dosing days. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must have a body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2), inclusive, and must weigh at least 55 kilogram (kg)
- All women of childbearing potential must practice highly effective contraception during the study and for a period of 90 days, which is expected to be more than 5 half-lives of BIIB107. Men must practice effective contraception during the study and for a period of 5 half-lives of BIIB107 or 90 days after their last dose of study treatment. In addition, participants should not donate sperm or eggs during the study and for at least 5 half-lives of BIIB107 or 90 days after their last dose of study treatment
- Negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction test at Screening and Check-in/admission.
Key exclusion criteria (14 listed)
- History of or positive test result at Screening for human immunodeficiency virus (HIV-1/HIV-2) antibodies
- Positive test result at Screening for hepatitis C virus (HCV) antibody (Ab).
- Current hepatitis B infection (defined as per protocol) and participants with immunity to hepatitis B from previous natural infection (defined as negative hepatitis B surface antigen [HBsAg], positive hepatitis B surface antibody [HBsAb], and positive total hepatitis B core antibody [HBcAb]).
- Signs of active herpes simplex type 1 and 2 or varicella within 4 weeks prior to randomization
- Evidence of current SARS-CoV-2 infection within 4 weeks prior to Screening, at Screening, between Screening and inpatient admission (Day -1), or at admission (Day -1), including but not limited to a fever (temperature >37.5°C), new and persistent cough, breathlessness, or loss of taste or smell, per the judgement of the Investigator.
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 |
|---|---|---|
| BIIB107Administered as specified in the treatment arm. | Drug | Cohort 1A, Cohort 1B, Cohort 2A, Cohort 2B, Cohort 3A, Cohort 4A, Cohort 5A, Cohort 7A, Cohort 8A |
| PlaceboAdministered as specified in the treatment arm. | Drug | Cohort 1A, Cohort 1B, Cohort 2A, Cohort 2B, Cohort 3A, Cohort 4A, Cohort 5A, Cohort 7A, Cohort 8A |
Primary outcome
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs): Single Ascending Dose (SAD)
Time frame: Day -1 up to Day 84
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event.
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs): Multiple Ascending Dose (MAD)
Time frame: Day -1 up to Day 169
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event.
18 secondary outcomes
Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUCinf): SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Maximum Observed Concentration (Cmax): SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Time to Reach Maximum Observed Concentration (Tmax): SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Terminal Half-Life (t1/2): SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Clearance (CL) for IV Doses: SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Apparent Clearance (CL/F) of SC Doses: SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Volume of Distribution at Steady State (Vss) for IV Doses: SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) for SC Doses: SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Bioavailability (F) of SC Doses: SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Absorption Rate Profile of SC Doses: SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Maximum Observed Concentration (Cmax): MAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Time to Reach Maximum Observed Concentration (Tmax): MAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau): MAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Trough Concentration (Ctrough): MAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Terminal Half-Life (t1/2): MAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Accumulation Ratio (R): MAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Apparent Clearance (CL/F) of SC Doses: MAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) for SC Doses: MAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
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. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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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.
Medical Director study director
Biogen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BIIB107 in people with Healthy Volunteers, run by Biogen at 3 sites 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 14 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 3 sites 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. 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?
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs): Single Ascending Dose (SAD) (time frame: Day -1 up to Day 84). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.