ImmunotherapyPhase 1/2NCT03695757
Development of a New Immunotherapy Using Intramuscular Administration of Autologous Total IgG
A Phase 1/2 study testing Part A) Healthy subjects and Part B) Advanced solid tumor in people with Immunotherapy, run by Ajou University School of Medicine at 1 site in South Korea.
Trial summary
The purpose of this prospective pilot clinical study is to evaluate the safety and immunostimulatory effect of intramuscularly administrations of autologous total IgG (autologous total IgG therapy) in healthy subjects and patients with advanced solid tumor (non-small cell lung cancer, stomach cancer, colon cancer… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Immunotherapy
- What is being tested?
- Part A) Healthy subjects and Part B) Advanced solid tumor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Nov 2018to 24 Mar 2021
- Phase
- Phase 1/2
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, 19 years or older
- Meeting the criteria for autologous blood donation 1) Body weight ≥32 kg (satisfying body weight limitation for planned sampling of 320 mL of venous blood volume) 2) Hemoglobin: ≥ 9 g/dL (Healthy volunteers Hemoglobin: ≥ 11 g/dL)
- Provide signed informed consent
- [Only for patients with advanced solid tumor] Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2 at the time of study enrollment.
- [Only for patients with advanced solid tumor] Patients with a life expectancy longer than 3 months and metastatic (stage Ⅲ, Ⅳ) advanced solid tumor (non-small cell lung cancer, stomach cancer, colon cancer, ovarian cancer, breast cancer, pancreatic cancer, cholangiocarcinoma, malignant melanoma, renal cell carcinoma, etc.)
- [Only for patients with advanced solid tumor] One or more target lesions must be present as confirmed by anatomical imaging (X-ray, CT sacn, MRI, etc.)
Who cannot join
- Subjects under the age of 19 year, or unable to agree on their own (emergency patients, patients with mental disability, patients with limited capacity to consent due to stroke or delirium caused by diabetes), or severe disease whose expected survival duration is less than 3 months
- Pregnancy or planned pregnancy within 1 year
- Subjects who participated on another investigational device or drug studies within 4 weeks prior to screening visit
- Medical history of alcohol or drug abuse within 2 years of the screening visit
- Subjects is a member of the investigational team
- Unable to comply with all clinic visits and study-related procedures
Show all 10Show fewer
- Planned or anticipated major surgical procedure within 4 weeks prior to baseline visit
- [Only for patients with advanced solid tumor] A well-treated patients in combination with surgery and radiotherapy
- [Only for patients with advanced solid tumor] Uncontrolled infections (bacterial, viral, fungal infection)
- [Only for patients with advanced solid tumor] Has known active brain metastases(except for subjects with adequate treated and neurological asymptomatic at least 2 weeks, subjects without neurological symptoms without treatment for brain metastases, also subjects must be either off corticosteroid for corticosteroid therapy, or who have received stable doses of prednisone less than 10mg daily or who have received reduced doses may be enrolled.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Immunostimulatory Effect of Intramuscular Administration of Autologous Total IgG in Human for Development of a New Immunotherapy
The purpose of this prospective pilot clinical study is to evaluate the safety and immunostimulatory effect of intramuscularly administrations of autologous total IgG (autologous total IgG therapy) in healthy subjects and patients with advanced solid tumor (non-small cell lung cancer, stomach cancer, colon cancer, ovarian cancer, breast cancer, pancreatic cancer, biliary cancer, melanoma, renal cell carcinoma etc.). In addition, antitumor effect of intramuscularly administrations of autologous total IgG in patients with advanced solid tumor will be also evaluated.
Read the detailed description
After providing informed consent, study participants will be assessed for study eligibility at the screening visit. At screening visit (week -4), venous blood (320~400 mL) will be sampled using a double blood bag containing anticoagulant. Autologous plasma will be separated from the venous blood by centrifugation. During the 4 weeks of screening period, autologous total IgG (purity ≥97%) will be aseptically purified from the autologous plasma by chromatography using Protein A. Participants will receive the 8 intramuscular injections of autologous total IgG, twice a week for 4 weeks from baseline (week 0).
The investigators will evaluate the safety and immunostimulatory effect of intervention of this study by analyzing side effects, serum concentrations of immunological parameters (immunoglobulin, cytokine, etc.), and lymphocyte fraction by flow cytometry analysis of peripheral blood mononuclear cells.
[Part A) Autologous total IgG therapy in healthy subjects] The duration of this clinical study in healthy subjects is 16 weeks from the screening visit. A 4-week screening period will be followed by a 4-week intervention period and an 8-week follow-up period.
[Part B) Autologous total IgG therapy in patients with advanced solid tumor] The duration of this clinical study in patients with advanced solid tumor is 12 weeks from the screening visit. A 4-week screening period will be followed by a 4-week intervention period and a 4-week follow-up period(1 cycle).
If the patients agree to participate in additional long-term repeated study interventions at the end of 1st cycle of visit, patients will receive repeated study interventions in same the schedule up to week 44 (maximum 4 cycles). At the end of each cycle, antitumor effect will be evaluated by serum tumor marker concentrations, anatomical imaging, and Response Evaluation Criteria in solid tumors (RECIST ver. 1.1).
- Conditions
- Immunotherapy
- Being tested
- Part A) Healthy subjects, Part B) Advanced solid tumor
- Keywords
- Immunoglobulin G, Treatment, Immunostimulatory effect, Tumor, Solid tumor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Part A) Healthy subjectsBiological
Also called Intramuscular injections of autologous total IgG
Part A) Autologous total IgG 50mg will be administered to the healthy subjects by intramuscular injections, twice a week for 4 weeks (total 8 injections).
Part B) Advanced solid tumorBiological
Also called Intramuscular injections of autologous total IgG
Part B) Autologous total IgG 50mg will be administered to the patients with advanced solid tumor by intramuscular injection, twice a week for 4 weeks (total 8 injections).
| Study group | Role | What they receive |
|---|---|---|
| Part A) Healthy subjects | Experimental | Part A) Autologous total IgG 50mg will be administered to the healthy subjects by intramuscular injections, twice a week for 4 weeks (total 8 injections). Receives: Biological: Part A) Healthy subjects |
| Part B) Advanced solid tumor | Experimental | Part B) Autologous total IgG 50mg will be administered to the patients with advanced solid tumor by intramuscular injection, twice a week for 4 weeks (total 8 injections). Receives: Biological: Part B) Advanced solid tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with severe adverse events (AEs), serious adverse events (SAEs), treatment-related AEs, deaths, or discontinuation of study intervention due to AEs in healthy subjects
Measured: From baseline to week 12
Number of participants with severe adverse events (AEs), serious adverse events (SAEs), treatment-related AEs, deaths, or discontinuation of study intervention due to AEs in patients with advanced solid tumor
Measured: From baseline to week 8 and through study completion, an average of 3 year
Secondary outcomes (18)
Number of participants with abnormal serum chemistry results and blood test results due to clinical study in healthy subjects
Measured: From baseline to week 12
Serum concentrations of immunological parameters (immunoglobulin, cytokine, etc.) in healthy subjects
Measured: From baseline to week 12
Lymphocyte fraction by flow cytometry analysis of peripheral blood mononuclear cells in healthy subjects
Measured: From baseline to week 12
Levels of cytokines secreted from peripheral blood cells in healthy subjects
Measured: From baseline to week 12
Quality of life (5-level EuroQoL Group's 5-dimension; EQ-5D-5L) in healthy subjects
The 5-level EuroQoL Group's 5-dimension (EQ-5D-5L) consists of 2 parts: the descriptive system and the EQ visual analogue scale (VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels of perceived problems: no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems. In addition, the EQ-5D-5L include an EQ-VAS where the endpoints are labeled on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: From baseline to week 12
Subjective index of pain and fatigue (Visual Analogue Scale; VAS, Numeral Rating Scale; NRS) in healthy subjects
The 100-mm Visual Analogue Scale (VAS) ranges from 0 (absent) to 10 (worst imaginable). The 11-point Numerical Rating Scale (NRS) ranges from 0 (absent) to 10 (worst imaginable).
Measured: From baseline to week 12
Number of participants with abnormal serum chemistry results and blood test results due to clinical study in patients with advanced solid tumor
Measured: From baseline to week 8 and through study completion, an average of 3 year
Serum concentrations of immunological parameters (immunoglobulin, cytokine, etc.) in patients with advanced solid tumor
Measured: From baseline to week 8 and through study completion, an average of 3 year
Lymphocyte fraction by flow cytometry analysis of peripheral blood mononuclear cells in patients with advanced solid tumor
Measured: From baseline to week 8 and through study completion, an average of 3 year
Levels of cytokines secreted from peripheral blood cells in patients with advanced solid tumor
Measured: From baseline to week 8 and through study completion, an average of 3 year
Objective response rate (ORR) in patients with advanced solid tumor
Measured: From baseline to week 8 and through study completion, an average of 3 year
Disease control rate (DCR) in patients with advanced solid tumor
Measured: From baseline to week 8 and through study completion, an average of 3 year
Duration of response (DOR) in patients with advanced solid tumor
Measured: From baseline to week 8 and through study completion, an average of 3 year
Progression-free survival (PFS) in patients with advanced solid tumor
Measured: From baseline to week 8 and through study completion, an average of 3 year
Overall survival (OS) in patients with advanced solid tumor
Measured: From baseline to week 8 and through study completion, an average of 3 year
The tumor marker concentrations in patients with advanced solid tumor
Measured: From baseline to week 8 and through study completion, an average of 3 year
Quality of life (5-level EuroQoL Group's 5-dimension; EQ-5D-5L) in patients with advanced solid tumor
The 5-level EuroQoL Group's 5-dimension (EQ-5D-5L) consists of 2 parts: the descriptive system and the EQ visual analogue scale (VAS). The EQ-5D-5L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels of perceived problems: no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems. In addition, the EQ-5D-5L include an EQ-VAS where the endpoints are labeled on a scale from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: From baseline to week 8 and through study completion, an average of 3 year
Subjective index of pain and fatigue (Visual Analogue Scale; VAS, Numeral Rating Scale; NRS) in patients with advanced solid tumor
The 100-mm Visual Analogue Scale (VAS) ranges from 0 (absent) to 10 (worst imaginable). The 11-point Numerical Rating Scale (NRS) ranges from 0 (absent) to 10 (worst imaginable).
Measured: From baseline to week 8 and through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2018
- Study start6 Nov 2018
- Primary completion26 Jan 2021
- Study completion24 Mar 2021
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 ImmunotherapyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Intramuscularly administrations of autologous total IgG in healthy subjects and patients with advanced solid tumor
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ajou University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Ho Nahm, Ajou University School of Medicine
- Investigators
- Dong-Ho Nahm, Principal investigator, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695757
- Sponsor's protocol ID
- AJIRB-MED-THE-18-236
- Status last verified
- Jul 2021
- First submitted
- 28 Sep 2018
- Last updated
- 6 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kwon B, Yang SJ, Cho SM, Kim ME, Nahm DH. Intramuscular administration of autologous total immunoglobulin G induces immunomodulatory effects on T cells in healthy human subjects: An open-labeled prospective single-arm trial. Medicine (Baltimore). 2022 Jun 3;101(22):e29486. doi: 10.1097/MD.0000000000029486.
PubMed 35665739
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunostimulatory Effect of Intramuscular Administration of Autologous Total IgG in Human for Development of a New Immunotherapy
- ClinicalTrials.gov ID
- NCT03695757
- Acronym / sponsor ID
- AJIRB-MED-THE-18-236
- Conditions
- Immunotherapy
- Keywords
- Immunoglobulin G, Treatment, Immunostimulatory effect, Tumor, Solid tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ajou University School of MedicineUniversity, hospital or other
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 26 Jan 2021 (actual)
- Study completion
- 24 Mar 2021 (actual)
- First posted
- 4 Oct 2018 (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 purpose of this prospective pilot clinical study is to evaluate the safety and immunostimulatory effect of intramuscularly administrations of autologous total IgG (autologous total IgG therapy) in healthy subjects and patients with advanced solid tumor (non-small cell lung cancer, stomach cancer, colon cancer, ovarian cancer, breast cancer, pancreatic cancer, biliary cancer, melanoma, renal cell carcinoma etc.). In addition, antitumor effect of intramuscularly administrations of autologous total IgG in patients with advanced solid tumor will be also evaluated.
Detailed description
After providing informed consent, study participants will be assessed for study eligibility at the screening visit. At screening visit (week -4), venous blood (320~400 mL) will be sampled using a double blood bag containing anticoagulant. Autologous plasma will be separated from the venous blood by centrifugation. During the 4 weeks of screening period, autologous total IgG (purity ≥97%) will be aseptically purified from the autologous plasma by chromatography using Protein A. Participants will receive the 8 intramuscular injections of autologous total IgG, twice a week for 4 weeks from baseline (week 0).
The investigators will evaluate the safety and immunostimulatory effect of intervention of this study by analyzing side effects, serum concentrations of immunological parameters (immunoglobulin, cytokine, etc.), and lymphocyte fraction by flow cytometry analysis of peripheral blood mononuclear cells.
[Part A) Autologous total IgG therapy in healthy subjects] The duration of this clinical study in healthy subjects is 16 weeks from the screening visit. A 4-week screening period will be followed by a 4-week intervention period and an 8-week follow-up period.
[Part B) Autologous total IgG therapy in patients with advanced solid tumor] The duration of this clinical study in patients with advanced solid tumor is 12 weeks from the screening visit. A 4-week screening period will be followed by a 4-week intervention period and a 4-week follow-up period(1 cycle).
If the patients agree to participate in additional long-term repeated study interventions at the end of 1st cycle of visit, patients will receive repeated study interventions in same the schedule up to week 44 (maximum 4 cycles). At the end of each cycle, antitumor effect will be evaluated by serum tumor marker concentrations, anatomical imaging, and Response Evaluation Criteria in solid tumors (RECIST ver. 1.1).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intramuscularly administrations of autologous total IgG in healthy subjects and patients with advanced solid tumor
| Arm | Type | Receives |
|---|---|---|
| Part A) Healthy subjects | Experimental | Biological: Part A) Healthy subjectsPart A) Autologous total IgG 50mg will be administered to the healthy subjects by intramuscular injections, twice a week for 4 weeks (total 8 injections). |
| Part B) Advanced solid tumor | Experimental | Biological: Part B) Advanced solid tumorPart B) Autologous total IgG 50mg will be administered to the patients with advanced solid tumor by intramuscular injection, twice a week for 4 weeks (total 8 injections). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, 19 years or older
- Meeting the criteria for autologous blood donation 1) Body weight ≥32 kg (satisfying body weight limitation for planned sampling of 320 mL of venous blood volume) 2) Hemoglobin: ≥ 9 g/dL (Healthy volunteers Hemoglobin: ≥ 11 g/dL)
- Provide signed informed consent
- [Only for patients with advanced solid tumor] Patients with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2 at the time of study enrollment.
- [Only for patients with advanced solid tumor] Patients with a life expectancy longer than 3 months and metastatic (stage Ⅲ, Ⅳ) advanced solid tumor (non-small cell lung cancer, stomach cancer, colon cancer, ovarian cancer, breast cancer, pancreatic cancer, cholangiocarcinoma, malignant melanoma, renal cell carcinoma, etc.)
Key exclusion criteria (10 listed)
- Subjects under the age of 19 year, or unable to agree on their own (emergency patients, patients with mental disability, patients with limited capacity to consent due to stroke or delirium caused by diabetes), or severe disease whose expected survival duration is less than 3 months
- Pregnancy or planned pregnancy within 1 year
- Subjects who participated on another investigational device or drug studies within 4 weeks prior to screening visit
- Medical history of alcohol or drug abuse within 2 years of the screening visit
- Subjects is a member of the investigational team
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 |
|---|---|---|
| Part A) Healthy subjectsAlso: Intramuscular injections of autologous total IgGPart A) Autologous total IgG 50mg will be administered to the healthy subjects by intramuscular injections, twice a week for 4 weeks (total 8 injections). | Biological | Part A) Healthy subjects |
| Part B) Advanced solid tumorAlso: Intramuscular injections of autologous total IgGPart B) Autologous total IgG 50mg will be administered to the patients with advanced solid tumor by intramuscular injection, twice a week for 4 weeks (total 8 injections). | Biological | Part B) Advanced solid tumor |
Primary outcome
Number of participants with severe adverse events (AEs), serious adverse events (SAEs), treatment-related AEs, deaths, or discontinuation of study intervention due to AEs in healthy subjects
Time frame: From baseline to week 12
Number of participants with severe adverse events (AEs), serious adverse events (SAEs), treatment-related AEs, deaths, or discontinuation of study intervention due to AEs in patients with advanced solid tumor
Time frame: From baseline to week 8 and through study completion, an average of 3 year
18 secondary outcomes
Number of participants with abnormal serum chemistry results and blood test results due to clinical study in healthy subjects
Time frame: From baseline to week 12
Serum concentrations of immunological parameters (immunoglobulin, cytokine, etc.) in healthy subjects
Time frame: From baseline to week 12
Lymphocyte fraction by flow cytometry analysis of peripheral blood mononuclear cells in healthy subjects
Time frame: From baseline to week 12
Levels of cytokines secreted from peripheral blood cells in healthy subjects
Time frame: From baseline to week 12
Quality of life (5-level EuroQoL Group's 5-dimension; EQ-5D-5L) in healthy subjects
Time frame: From baseline to week 12
Subjective index of pain and fatigue (Visual Analogue Scale; VAS, Numeral Rating Scale; NRS) in healthy subjects
Time frame: From baseline to week 12
Number of participants with abnormal serum chemistry results and blood test results due to clinical study in patients with advanced solid tumor
Time frame: From baseline to week 8 and through study completion, an average of 3 year
Serum concentrations of immunological parameters (immunoglobulin, cytokine, etc.) in patients with advanced solid tumor
Time frame: From baseline to week 8 and through study completion, an average of 3 year
Lymphocyte fraction by flow cytometry analysis of peripheral blood mononuclear cells in patients with advanced solid tumor
Time frame: From baseline to week 8 and through study completion, an average of 3 year
Levels of cytokines secreted from peripheral blood cells in patients with advanced solid tumor
Time frame: From baseline to week 8 and through study completion, an average of 3 year
Objective response rate (ORR) in patients with advanced solid tumor
Time frame: From baseline to week 8 and through study completion, an average of 3 year
Disease control rate (DCR) in patients with advanced solid tumor
Time frame: From baseline to week 8 and through study completion, an average of 3 year
Duration of response (DOR) in patients with advanced solid tumor
Time frame: From baseline to week 8 and through study completion, an average of 3 year
Progression-free survival (PFS) in patients with advanced solid tumor
Time frame: From baseline to week 8 and through study completion, an average of 3 year
Overall survival (OS) in patients with advanced solid tumor
Time frame: From baseline to week 8 and through study completion, an average of 3 year
The tumor marker concentrations in patients with advanced solid tumor
Time frame: From baseline to week 8 and through study completion, an average of 3 year
Quality of life (5-level EuroQoL Group's 5-dimension; EQ-5D-5L) in patients with advanced solid tumor
Time frame: From baseline to week 8 and through study completion, an average of 3 year
Subjective index of pain and fatigue (Visual Analogue Scale; VAS, Numeral Rating Scale; NRS) in patients with advanced solid tumor
Time frame: From baseline to week 8 and through study completion, an average of 3 year
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 6 Jul 2021.
- Derived from this study: PubMed 35665739Kwon B, Yang SJ, Cho SM, Kim ME, Nahm DH. Intramuscular administration of autologous total immunoglobulin G induces immunomodulatory effects on T cells in healthy human subjects: An open-labeled prospective single-arm trial. Medicine (Baltimore). 2022 Jun 3;101(22):e29486. doi: 10.1097/MD.0000000000029486.
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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.
Dong-Ho Nahm principal investigator
Ajou University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Part A) Healthy subjects and Part B) Advanced solid tumor in people with Immunotherapy, run by Ajou University School of Medicine at 1 site in South Korea.
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 6 inclusion and 10 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 6 Jul 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 South Korea. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 severe adverse events (AEs), serious adverse events (SAEs), treatment-related AEs, deaths, or discontinuation of study intervention due to AEs in healthy subjects (time frame: From baseline to week 12). 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?
On the ClinicalTrials.gov record for NCT03695757, 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 6 Jul 2021.