Healthy VolunteersPhase 1NCT04265911

Single Ascending Dose of ASP3772 Study in Japanese Healthy Male and Female Adults, and Single Ascending Dose Study of ASP3772 in Comparison With PPSV23 in Japanese Elderly Male and Female Subjects

A Phase 1 study testing ASP3772 (subcutaneous), ASP3772 (intramuscular) and PPSV23 (subcutaneous) in people with Healthy Volunteers, run by Affinivax, Inc. at 1 site in Japan.

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

The purpose of this study is to evaluate the safety and tolerability of 3 different dose levels of ASP3772 administered subcutaneously or intramuscularly to Japanese healthy adults 20 to 49 years of age. Read more about this study

Who is it for?: Ages 20 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: ASP3772 (subcutaneous), ASP3772 (intramuscular) and PPSV23 (subcutaneous)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 1 siteJapan
Study dates: 19 Feb 2020to 7 Nov 2020
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 20 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Group 1: Subject is a healthy male or female between 20 and 49 years of age inclusive, at informed consent.
Group 2: Subject is a male or female between 65 and 85 years of age inclusive, at informed consent who is healthy or has chronic controlled, stable disease with no change in disease severity, medical therapy and no hospitalization history in last 12 weeks from informed consent as determined by medical history, physical examination, and laboratory data.
Female subject of non-childbearing potential; male subject not able to father children or who is able to father children and willing to use a highly effective method of contraception.
Subject agrees not to participate in another interventional study while participating in the present study.
Subject has a body mass index (BMI) range of 17.6 to 26.4 kg/m^2 inclusive in Group 1 and 15.4 to 28.6 kg/m^2 inclusive in Group 2, and body weight at least 50 kg for male and 40 kg for female at screening.

Who cannot join

Subject has had previous vaccination with any licensed or investigational pneumococcal vaccine at any time.
Subject has a history of microbiologically-proven invasive disease caused by Streptococcus pneumoniae.
Subject has an immune disorder(s) (including autoimmune disease), clinical conditions requiring immunosuppressive drugs and/or a close relative who has congenital immunodeficiency.
Group 1: Subject has any illness that requires medication or treatment.
Group 2: Subject has any evidence of unstable or active clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease, e.g., uncontrolled hypertension, uncontrolled diabetes, heart failure, uncontrolled chronic obstructive pulmonary disease, end-stage renal disease, malignancy which is active and requires treatment.
Subject has any clinically significant history of allergic conditions including drug allergies, asthma or anaphylactic reactions, but excluding untreated asymptomatic seasonal allergies just before study vaccine administration.
Subject has a positive serology test for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis A virus antibodies (immunoglobulin M), hepatitis C virus antibodies (anti-HCV) or antigens/antibodies to human immunodeficiency virus (HIV) type 1 and/or type 2 at screening.
Subject has/had febrile illness or symptomatic of viral, bacterial (including upper respiratory infection) or fungal (excluding skin infection) infection within 7 days prior to day 1.

Trial locations and contacts

1 site in 1 country.

Japan1 site

JP81001
Fukuoka

Other trials in Japan

About this study

Official title: ASP3772 Phase 1 Study: Single Ascending Dose Study in Japanese Healthy Male and Female Adults, and PPSV23-controlled, Randomized, Single Ascending Dose Study in Japanese Elderly Male and Female Subjects

This study will also evaluate the safety and tolerability of 3 different dose levels of ASP3772 administered subcutaneously or intramuscularly, in comparison to the active comparator 23-valent pneumococcal polysaccharide vaccine (PPSV23) in Japanese elderly subjects 65 to 85 years of age.

Conditions: Healthy Volunteers
Being tested: ASP3772 (subcutaneous), ASP3772 (intramuscular), PPSV23 (subcutaneous), PPSV23 (intramuscular)
Keywords: Pneumococcal vaccine, ASP3772

What participants receive

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

ASP3772 (subcutaneous)Biological
Subcutaneous injection
ASP3772 (intramuscular)Biological
Intramuscular injection
PPSV23 (subcutaneous)Biological
Also called Pneumovax NP
Subcutaneous injection
PPSV23 (intramuscular)Biological
Also called Pneumovax NP
Intramuscular injection

Study groups in NCT04265911
Study group	Role	What they receive
ASP3772 (subcutaneous) in Adults	Experimental	Participants will receive a single dose of ASP3772 administered as an subcutaneous injection on Day 1 at one of three dose levels. Receives: Biological: ASP3772 (subcutaneous)
ASP3772 ((intramuscular) in Adults	Experimental	Participants will receive a single dose of ASP3772 administered as an intramuscular injection on Day 1 at one of three dose levels. Receives: Biological: ASP3772 (intramuscular)
ASP3772 (subcutaneous) in Elderly	Experimental	Participants will receive a single dose of ASP3772 administered as an subcutaneous injection on Day 1 at one of three dose levels. Receives: Biological: ASP3772 (subcutaneous)
ASP3772 (intramuscular) in Elderly	Experimental	Participants will receive a single dose of ASP3772 administered as an intramuscular injection on Day 1 at one of three dose levels Receives: Biological: ASP3772 (intramuscular)
PPSV23 (subcutaneous) in Elderly	Active comparator	Participants will receive a single subcutaneous injection of the standard dose of PPSV23 on Day 1. Receives: Biological: PPSV23 (subcutaneous)
PPSV23 (intramuscular) in Elderly	Active comparator	Participants will receive a single intramuscular injection of the standard dose of PPSV23 on Day 1. Receives: Biological: PPSV23 (intramuscular)

What is being measured

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

Percentage of participants with treatment emergent adverse events (TEAEs) including serious AEs (SAEs), medically attended adverse events (MAAEs), potentially immune mediated medical conditions (PIMMCs) and new onset chronic diseases (NOCDs)
An adverse event (AE) is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. TEAE is defined as an AE occurring after study immunization to the last visit (up to 30 days post-vaccination if the study is discontinued for an individual subject). An IP-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator or subinvestigator.
Measured: Up to Day 30
Percentage of participants with vital sign abnormalities and/or adverse events (AEs)
Percentage of participants with potentially clinically significant vital sign values.
Measured: Up to Day 30
Percentage of participants reporting solicited local adverse reactions
Local reactions include pain, tenderness, erythema/redness, swelling, and induration. The reaction will be graded with 4-range grade: 1 (mild) to 4 (potentially life-threatening).
Measured: Up to Day 7
Percentage of participants reporting solicited systemic adverse reactions
Systemic reactions include nausea, vomiting, diarrhea, headache, fever, fatigue and myalgia and arthralgia. Vital signs up to 7 days postvaccination are collected as systemic reactions. The reaction will be graded with 4-range grade: 1 (mild) to 4 (potentially life-threatening).
Measured: Up to Day 7
Percentage of participants with laboratory value abnormalities and/or adverse events (AEs)
Percentage of participants with potentially clinically significant laboratory values.
Measured: Up to Day 30
Percentage of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Percentage of participants with potentially clinically significant ECG values.
Measured: Up to Day 30
Percentage of participants with physical exam abnormalities and/or adverse events (AEs)
Percentage of participants with potentially clinically significant physical exam values.
Measured: Up to Day 30

Secondary outcomes (14)

Geometric mean titer (GMT) for opsonophagocytic activity (OPA) for each serotype contained in ASP3772
OPA measure will be used to characterize the immunological response on Day 30 after administration of ASP3772.
Measured: On Day 30
GMT for OPA for each serotype contained in PPSV23
OPA measure will be used to characterize the immunological response on Day 30 after administration of PPSV23
Measured: On Day 30
Ratio of the OPA GMT (each ASP3772 dose level/PPSV23)
OPA measure will be used to characterize the immunological response on Day 30 after administration of ASP3772 and PPSV23
Measured: On Day 30
Geometric mean concentration (GMC) for pneumococcal serotype-specific anticapsular polysaccharide immunoglobulin G (PS IgG) for each serotype contained in ASP3772
PS IgG measure will be used to characterize the immunological response on Day 30 after administration of ASP3772.
Measured: On Day 30
GMC for pneumococcal serotype-specific anticapsular PS IgG for each serotype contained in PPSV23
PS IgG measure measure will be used to characterize the immunological response on Day 30 after administration of PPSV23
Measured: On Day 30
Ratio of GMC for pneumococcal serotype-specific anticapsular PS IgG (each ASP3772 dose level/PPSV23)
PS IgG measure will be used to characterize the immunological response on Day 30 after administration of ASP3772 and PPSV23.
Measured: On Day 30
Geometric mean fold rise (GMFR) in anticapsular PS IgG concentration on day 30 relative to pre-immunization contained in ASP3772
PS IgG measure will be used to characterize the immunological response on Day 30 after administration of ASP3772.
Measured: On Day 30
GMFR in anticapsular PS IgG concentration on day 30 relative to pre-immunization contained in PPSV23
PS IgG measure will be used to characterize the immunological response on Day 30 after administration of PPSV23
Measured: On Day 30
GMFR in OPA titer on day 30 relative to pre-immunization contained in ASP3772
OPA titer will be used to characterize the immunological response on Day 30 after administration of ASP3772.
Measured: On Day 30
GMFR in OPA titer on day 30 relative to pre-immunization contained in PPSV23
OPA titer will be used to characterize the immunological response on Day 30 after administration of PPSV23
Measured: On Day 30
Proportion of subjects with a ≥ 4-fold increase relative to baseline in pneumococcal serotype-specific anticapsular PS IgG concentration for each serotype contained in ASP3772
PS IgG measure will be used to characterize the immunological response on Day 30 after administration of ASP3772.
Measured: On Day 30
Proportion of subjects with a ≥ 4-fold increase relative to baseline in pneumococcal serotype-specific anticapsular PS IgG concentration for each serotype contained in PPSV23
PS IgG measure will be used to characterize the immunological response on Day 30 after administration of PPSV23
Measured: On Day 30
Proportion of subjects with a ≥ 4-fold increase relative to baseline in OPA titer for each serotype contained in ASP3772
OPA titer will be used to characterize the immunological response on Day 30 after administration of ASP3772.
Measured: On Day 30
Proportion of subjects with a ≥ 4-fold increase relative to baseline in OPA titer for each serotype contained in PPSV23
OPA titer will be used to characterize the immunological response on Day 30 after administration of PPSV23
Measured: On Day 30

Timeline

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

19 Feb 20207 Nov 2020

First posted12 Feb 2020
Study start19 Feb 2020
Primary completion7 Nov 2020
Study completion7 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Healthy VolunteersStudies 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: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04265911
Sponsor's protocol ID: 3772-CL-1011
Status last verified: Apr 2022
First submitted: 9 Feb 2020
Last updated: 2 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Publications

Borys D, Smulders R, Haranaka M, Nakano T, Chichili GR, Ebara M, Hashimoto A, Iwahana M, Oizumi Y, Nanra J, Malley R, Sebastian S. Safety, reactogenicity, and immunogenicity of a novel 24-valent pneumococcal vaccine candidate in healthy, pneumococcal vaccine-naive Japanese adults: A phase 1 randomized dose-escalation trial. Vaccine. 2025 Jan 12;44:126545. doi: 10.1016/j.vaccine.2024.126545. Epub 2024 Nov 29.
PubMed 39612802

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 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: ASP3772 Phase 1 Study: Single Ascending Dose Study in Japanese Healthy Male and Female Adults, and PPSV23-controlled, Randomized, Single Ascending Dose Study in Japanese Elderly Male and Female Subjects
ClinicalTrials.gov ID: NCT04265911
Acronym / sponsor ID: 3772-CL-1011
Conditions: Healthy Volunteers
Keywords: Pneumococcal vaccine, ASP3772
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Affinivax, Inc.Industry (pharma, biotech, devices)
Study start: 19 Feb 2020 (actual)
Primary completion: 7 Nov 2020 (actual)
Study completion: 7 Nov 2020 (actual)
First posted: 12 Feb 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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
ASP3772 (subcutaneous) in Adults	Experimental	Biological: ASP3772 (subcutaneous)Participants will receive a single dose of ASP3772 administered as an subcutaneous injection on Day 1 at one of three dose levels.
ASP3772 ((intramuscular) in Adults	Experimental	Biological: ASP3772 (intramuscular)Participants will receive a single dose of ASP3772 administered as an intramuscular injection on Day 1 at one of three dose levels.
ASP3772 (subcutaneous) in Elderly	Experimental	Biological: ASP3772 (subcutaneous)Participants will receive a single dose of ASP3772 administered as an subcutaneous injection on Day 1 at one of three dose levels.
ASP3772 (intramuscular) in Elderly	Experimental	Biological: ASP3772 (intramuscular)Participants will receive a single dose of ASP3772 administered as an intramuscular injection on Day 1 at one of three dose levels
PPSV23 (subcutaneous) in Elderly	Active comparator	Biological: PPSV23 (subcutaneous)Participants will receive a single subcutaneous injection of the standard dose of PPSV23 on Day 1.
PPSV23 (intramuscular) in Elderly	Active comparator	Biological: PPSV23 (intramuscular)Participants will receive a single intramuscular injection of the standard dose of PPSV23 on Day 1.

Who may qualify

Ages: 20 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Group 1: Subject is a healthy male or female between 20 and 49 years of age inclusive, at informed consent.
Group 2: Subject is a male or female between 65 and 85 years of age inclusive, at informed consent who is healthy or has chronic controlled, stable disease with no change in disease severity, medical therapy and no hospitalization history in last 12 weeks from informed consent as determined by medical history, physical examination, and laboratory data.
Female subject of non-childbearing potential; male subject not able to father children or who is able to father children and willing to use a highly effective method of contraception.
Subject agrees not to participate in another interventional study while participating in the present study.
Subject has a body mass index (BMI) range of 17.6 to 26.4 kg/m^2 inclusive in Group 1 and 15.4 to 28.6 kg/m^2 inclusive in Group 2, and body weight at least 50 kg for male and 40 kg for female at screening.

Key exclusion criteria (8 listed)

Subject has had previous vaccination with any licensed or investigational pneumococcal vaccine at any time.
Subject has a history of microbiologically-proven invasive disease caused by Streptococcus pneumoniae.
Subject has an immune disorder(s) (including autoimmune disease), clinical conditions requiring immunosuppressive drugs and/or a close relative who has congenital immunodeficiency.
Group 1: Subject has any illness that requires medication or treatment.
Group 2: Subject has any evidence of unstable or active clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease, e.g., uncontrolled hypertension, uncontrolled diabetes, heart failure, uncontrolled chronic obstructive pulmonary disease, end-stage renal disease, malignancy which is active and requires treatment.

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
ASP3772 (subcutaneous)Subcutaneous injection	Biological	ASP3772 (subcutaneous) in Adults, ASP3772 (subcutaneous) in Elderly
ASP3772 (intramuscular)Intramuscular injection	Biological	ASP3772 ((intramuscular) in Adults, ASP3772 (intramuscular) in Elderly
PPSV23 (subcutaneous)Also: Pneumovax NPSubcutaneous injection	Biological	PPSV23 (subcutaneous) in Elderly
PPSV23 (intramuscular)Also: Pneumovax NPIntramuscular injection	Biological	PPSV23 (intramuscular) in Elderly

Primary outcome

Percentage of participants with treatment emergent adverse events (TEAEs) including serious AEs (SAEs), medically attended adverse events (MAAEs), potentially immune mediated medical conditions (PIMMCs) and new onset chronic diseases (NOCDs)
Time frame: Up to Day 30
An adverse event (AE) is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. TEAE is defined as an AE occurring after study immunization to the last visit (up to 30 days post-vaccination if the study is discontinued for an individual subject). An IP-related TEAE is defined as any TEAE with a causal relationship assessed as "yes" by the investigator or subinvestigator.
Percentage of participants with vital sign abnormalities and/or adverse events (AEs)
Time frame: Up to Day 30
Percentage of participants with potentially clinically significant vital sign values.
Percentage of participants reporting solicited local adverse reactions
Time frame: Up to Day 7
Local reactions include pain, tenderness, erythema/redness, swelling, and induration. The reaction will be graded with 4-range grade: 1 (mild) to 4 (potentially life-threatening).
Percentage of participants reporting solicited systemic adverse reactions
Time frame: Up to Day 7
Systemic reactions include nausea, vomiting, diarrhea, headache, fever, fatigue and myalgia and arthralgia. Vital signs up to 7 days postvaccination are collected as systemic reactions. The reaction will be graded with 4-range grade: 1 (mild) to 4 (potentially life-threatening).
Percentage of participants with laboratory value abnormalities and/or adverse events (AEs)
Time frame: Up to Day 30
Percentage of participants with potentially clinically significant laboratory values.
Percentage of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Time frame: Up to Day 30
Percentage of participants with potentially clinically significant ECG values.
Percentage of participants with physical exam abnormalities and/or adverse events (AEs)
Time frame: Up to Day 30
Percentage of participants with potentially clinically significant physical exam values.

14 secondary outcomes

Geometric mean titer (GMT) for opsonophagocytic activity (OPA) for each serotype contained in ASP3772
Time frame: On Day 30
GMT for OPA for each serotype contained in PPSV23
Time frame: On Day 30
Ratio of the OPA GMT (each ASP3772 dose level/PPSV23)
Time frame: On Day 30
Geometric mean concentration (GMC) for pneumococcal serotype-specific anticapsular polysaccharide immunoglobulin G (PS IgG) for each serotype contained in ASP3772
Time frame: On Day 30
GMC for pneumococcal serotype-specific anticapsular PS IgG for each serotype contained in PPSV23
Time frame: On Day 30
Ratio of GMC for pneumococcal serotype-specific anticapsular PS IgG (each ASP3772 dose level/PPSV23)
Time frame: On Day 30
Geometric mean fold rise (GMFR) in anticapsular PS IgG concentration on day 30 relative to pre-immunization contained in ASP3772
Time frame: On Day 30
GMFR in anticapsular PS IgG concentration on day 30 relative to pre-immunization contained in PPSV23
Time frame: On Day 30
GMFR in OPA titer on day 30 relative to pre-immunization contained in ASP3772
Time frame: On Day 30
GMFR in OPA titer on day 30 relative to pre-immunization contained in PPSV23
Time frame: On Day 30
Proportion of subjects with a ≥ 4-fold increase relative to baseline in pneumococcal serotype-specific anticapsular PS IgG concentration for each serotype contained in ASP3772
Time frame: On Day 30
Proportion of subjects with a ≥ 4-fold increase relative to baseline in pneumococcal serotype-specific anticapsular PS IgG concentration for each serotype contained in PPSV23
Time frame: On Day 30
Proportion of subjects with a ≥ 4-fold increase relative to baseline in OPA titer for each serotype contained in ASP3772
Time frame: On Day 30
Proportion of subjects with a ≥ 4-fold increase relative to baseline in OPA titer for each serotype contained in PPSV23
Time frame: On Day 30

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 2 May 2022.
Derived from this study: PubMed 39612802Borys D, Smulders R, Haranaka M, Nakano T, Chichili GR, Ebara M, Hashimoto A, Iwahana M, Oizumi Y, Nanra J, Malley R, Sebastian S. Safety, reactogenicity, and immunogenicity of a novel 24-valent pneumococcal vaccine candidate in healthy, pneumococcal vaccine-naive Japanese adults: A phase 1 randomized dose-escalation trial. Vaccine. 2025 Jan 12;44:126545. doi: 10.1016/j.vaccine.2024.126545. Epub 2024 Nov 29.
Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

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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.

Central Contact study director

Astellas Pharma 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 ASP3772 (subcutaneous), ASP3772 (intramuscular) and PPSV23 (subcutaneous) in people with Healthy Volunteers, run by Affinivax, Inc. at 1 site in Japan.

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 5 inclusion and 8 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 2 May 2022. 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 Japan. 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?

Percentage of participants with treatment emergent adverse events (TEAEs) including serious AEs (SAEs), medically attended adverse events (MAAEs), potentially immune mediated medical conditions (PIMMCs) and new onset chronic diseases (NOCDs) (time frame: Up to Day 30). The study lists 7 primary outcomes in all. 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 NCT04265911, 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 2 May 2022.