Idiopathic Pulmonary FibrosisPhase 1NCT05022771
A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of PMG1015
A Phase 1 study testing PMG1015 Dose 1, PMG1015 Dose 2 and PMG1015 Dose 3 in people with Idiopathic Pulmonary Fibrosis, run by Pulmongene Ltd. at 1 site in Australia.
Trial summary
This is a Phase 1A, first in human, randomized, double-blinded, placebo-controlled, dose escalation study of PMG1015 in healthy adult volunteers. PMG1015 is a monoclonal antibody, being developed as a novel therapeutic treatment for patients with Idiopathic Pulmonary fibrosis (IPF). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- PMG1015 Dose 1, PMG1015 Dose 2 and PMG1015 Dose 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Oct 2021to 18 Aug 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or non-pregnant, non-lactating female volunteers, between 18 and 60 years of age, inclusive at the time of informed consent.
- Body mass index (BMI) between 17.5 and 32.0 kg/m2 (inclusive) and body weight between 50 and 100 kg for males and between 45 and 100 kg for females.
- No clinically significant clinical laboratory values (Hematology, coagulation, biochemistry and urinalysis) at the discretion of the PI.
- Females of child bearing potential must use an acceptable, highly effective double contraception and have a negative pregnancy test at Screening and Day-1.
- Documented evidence of surgical sterilization at least 6 months prior to screening for women or vasectomy at least 90 days prior to screening.
- Women not of child bearing potential must be menopausal for >/= 12 months.
- Males must not donate sperms for at least 90 days after PMG1015 administration.
Who cannot join
- History or evidence of clinically significant condition, including but not limited to any cardiovascular, gastrointestinal, endocrinologic, hematologic, psychiatric, renal disease, musculoskeletal, infectious, or neurological condition or any chronic medical condition and/or other major disease, as determined by the PI.
- A PR < 40 or > 100 beats per minute, mean systolic blood pressure (SBP) > 140 mmHg, or mean diastolic blood pressure (DBP) > 95 mmHg .
- A mean corrected QT interval using Fridericia's formula (QTcF) interval at Screening > 450 ms in males and > 470 ms in females. If the mean QTcF exceeds these limits, one additional triplicate ECG will be performed.
- Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, in the judgment of the PI, may interfere with the interpretation of QTc-interval changes, including abnormal ST-T wave morphology or left ventricular hypertrophy.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or creatinine > 1.5 × the upper limit of the normal range (ULN) or total bilirubin or lymphocyte counts > ULN.
- Participants with a positive toxicology screening panel or alcohol breath test on Screening/Day-1.
Show all 21Show fewer
- Participants with a history of substance abuse or dependency or history of recreational IV drug use over the last 2 years.
- Plasma donation/Blood donation or significant blood loss within 60 days prior to the first IP administration.
- Use of any IP (including other investigational mAb products) or investigational medical device within 30 days prior to Screening or 5 half-lives of the product (whichever is the longest) or participation in more than 4 investigational drug studies within 1 year prior to screening.
- Major surgery (general anesthetic) within 3 months or minor surgery (local anesthetic) within 1 month prior to IP administration, or planned surgery during the study period, which is determined by the PI to be clinically relevant.
- Fever or symptomatic bacterial or viral infection.
- Participants who have received live vaccines or attenuated vaccines within 1 month before dosing.
- Participants with any active malignancy or history of malignancy within 5 years prior to enrolment.
- Use of any other prescription medications.
- History of anaphylaxis, allergic reactions to the excipients of IP, asthma.
- Positive blood screen for HIV1/2 antibody, Hepatitis B surface antigen, hepatitis C virus, or syphilis at screening.
- Participants with an inability to tolerate venous access.
- Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period.
- An employee of Pulmongene or Novotech (Australia) Pty Ltd.
- Participant is unwilling to abstain from alcohol beginning 48 hours prior to admission to the CRU and while resident at the CRU.
- Any other condition or finding that in the opinion of the PI or designee would put the participant or study conduct at risk.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Q-Pharm Pty Ltd, Clive Berghofer Cancer Research Centre
Herston, Queensland, 4006
About this study
Official title: A Phase 1A, First in Human, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of PMG1015 in Healthy Volunteers
This is a Phase 1A, first in human, randomized, double-blinded, placebo-controlled, dose escalation study of PMG1015 in healthy adult volunteers. PMG1015 is a monoclonal antibody, being developed as a novel therapeutic treatment for patients with Idiopathic Pulmonary fibrosis (IPF). This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PMG1015 after Single ascending doses (SAD).
Read the detailed description
Participants will be enrolled and randomized into 1 of 7 cohorts in a double-blind manner.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- PMG1015 Dose 1, PMG1015 Dose 2, PMG1015 Dose 3, PMG1015 Dose 4, PMG1015 Dose 5
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMG1015 Dose 1Drug
Also called PMG1015
Dose level 1 of PMG1015
PMG1015 Dose 2Drug
Also called PMG1015
Dose level 2 of PMG1015
PMG1015 Dose 3Drug
Also called PMG1015
Dose level 3 of PMG1015
PMG1015 Dose 4Drug
Also called PMG1015
Dose level 4 of PMG1015
PMG1015 Dose 5Drug
Also called PMG1015
Dose level 5 of PMG1015
PMG1015 Dose 6Drug
Also called PMG1015
Dose level 6 of PMG1015
PlaceboDrug
Placebo to match
PMG1015 Dose 7Drug
Also called PMG1015
Dose level 7 of PMG1015
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Doses Cohort 1a | Experimental | Subjects will receive either Dose level 1 of PMG1015 or Placebo Receives: Drug: PMG1015 Dose 1; Drug: Placebo |
| Single Ascending Doses Cohort 1b | Experimental | Subjects will receive either Dose level 2 of PMG1015 or Placebo Receives: Drug: PMG1015 Dose 2; Drug: Placebo |
| Single Ascending Doses Cohort 1c | Experimental | Subjects will receive either Dose level 3 of PMG1015 or Placebo Receives: Drug: PMG1015 Dose 3; Drug: Placebo |
| Single Ascending Doses Cohort 1d | Experimental | Subjects will receive either Dose level 4 of PMG1015 or Placebo Receives: Drug: PMG1015 Dose 4; Drug: Placebo |
| Single Ascending Doses Cohort 1e | Experimental | Subjects will receive either Dose level 5 of PMG1015 or Placebo Receives: Drug: PMG1015 Dose 5; Drug: Placebo |
| Single Ascending Doses Cohort 1f | Experimental | Subjects will receive either Dose level 6 of PMG1015 or Placebo Receives: Drug: PMG1015 Dose 6; Drug: Placebo |
| Single Ascending Doses Cohort 1g | Experimental | Subjects will receive either Dose level 7 of PMG1015 or Placebo Receives: Drug: Placebo; Drug: PMG1015 Dose 7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Treatment-emergent adverse events (TEAEs)
An Adverse Event (AE) is any event, side-effect or any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are AEs that occur following the start of treatment.
Measured: Day 1-Day 85
The severity of Treatment-emergent adverse events (TEAEs)
TEAEs are AEs that occur following the start of treatment.
Measured: Day 1-Day 85
The incidence of Serious adverse events (SAEs)
A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of IP (active or placebo) that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect.
Measured: Day 1-Day 85
The severity of Serious adverse events (SAEs)
A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of IP (active or placebo) that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect.
Measured: Day 1- Day 85
Number of participants with abnormally clinical vital signs
Vital signs include pulse rate (PR), blood pressure (BP), respiratory rate (RR) and tympanic temperature (T)
Measured: Day 1- Day 85
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
All ECG tracings will be reviewed by the PI or designee and assessed for clinical significance.
Measured: Day 1-Day 85.
Number of participants with abnormal clinically significant clinical laboratory results
Clinical laboratory test include hematology, coagulation, biochemistry, and urinalysis.
Measured: Day 1- Day 85
MTD of PMG1015 in healthy participants
Maximum tolerated dose of PMG1015 in healthy participants
Measured: Day 1- Day 85
Number of patients with abnormal clinically significant results from physical examination
Complete physical examination include, general appearance, head, eyes, ears, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes.
Measured: Day 1-Day 85
Secondary outcomes (10)
Area under the serum-concentration time curve (AUC) from time zero (from the start of infusion time) to the last time point with measurable analyte concentration (AUC0-t)
Area under the plasma concentration versus time curve (AUC) from time 0 to time of last quantifiable concentration
Measured: Day 1-Day 85.
AUC from time zero to infinity (AUC0-∞)
Area under the plasma concentration versus time curve (AUC) from time 0 (from the start of infusion) extrapolated to infinity
Measured: Day 1-Day 85.
To determine %AUCexp
The percentage of the AUC that has been extrapolated beyond the last observed data point
Measured: Day 1-Day 85.
To determine Cmax
Maximum observed serum PMG1015 concentration
Measured: Day 1-Day 85.
To determine Tmax, derived from serum concentration of each dose of PMG1015
Time to maximum observed concentration
Measured: Day 1-Day 85.
To determine t1/2
Terminal elimination half life summarized by dosing regimen
Measured: Day 1-Day 85.
Apparent total body clearance (CL)
CL is the measure of the rate at which a drug is metabolized or eliminated by normal biological processes
Measured: Day 1-Day 85.
Apparent volume of distribution during the terminal phase (Vz)
Vz is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Measured: Day 1-Day 85.
Apparent terminal elimination rate constant (λz or kel)
λz is calculated using log-linear regression of the terminal portions of the plasma concentrations versus time curves.
Measured: Day 1-Day 85.
Levels of ADA
Anti-drug antibody levels in blood
Measured: Day 1-Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start14 Oct 2021
- Primary completion18 Aug 2022
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pulmongene Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Friend, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022771
- Sponsor's protocol ID
- PMG1015-AUS-101
- Status last verified
- Jan 2023
- First submitted
- 20 Aug 2021
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1A, First in Human, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of PMG1015 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05022771
- Acronym / sponsor ID
- PMG1015-AUS-101
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Pulmongene Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2021 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 26 Aug 2021 (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.
This is a Phase 1A, first in human, randomized, double-blinded, placebo-controlled, dose escalation study of PMG1015 in healthy adult volunteers. PMG1015 is a monoclonal antibody, being developed as a novel therapeutic treatment for patients with Idiopathic Pulmonary fibrosis (IPF). This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PMG1015 after Single ascending doses (SAD).
Detailed description
Participants will be enrolled and randomized into 1 of 7 cohorts in a double-blind manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Doses Cohort 1a | Experimental | Drug: PMG1015 Dose 1, Drug: PlaceboSubjects will receive either Dose level 1 of PMG1015 or Placebo |
| Single Ascending Doses Cohort 1b | Experimental | Drug: PMG1015 Dose 2, Drug: PlaceboSubjects will receive either Dose level 2 of PMG1015 or Placebo |
| Single Ascending Doses Cohort 1c | Experimental | Drug: PMG1015 Dose 3, Drug: PlaceboSubjects will receive either Dose level 3 of PMG1015 or Placebo |
| Single Ascending Doses Cohort 1d | Experimental | Drug: PMG1015 Dose 4, Drug: PlaceboSubjects will receive either Dose level 4 of PMG1015 or Placebo |
| Single Ascending Doses Cohort 1e | Experimental | Drug: PMG1015 Dose 5, Drug: PlaceboSubjects will receive either Dose level 5 of PMG1015 or Placebo |
| Single Ascending Doses Cohort 1f | Experimental | Drug: PMG1015 Dose 6, Drug: PlaceboSubjects will receive either Dose level 6 of PMG1015 or Placebo |
| Single Ascending Doses Cohort 1g | Experimental | Drug: Placebo, Drug: PMG1015 Dose 7Subjects will receive either Dose level 7 of PMG1015 or Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male or non-pregnant, non-lactating female volunteers, between 18 and 60 years of age, inclusive at the time of informed consent.
- Body mass index (BMI) between 17.5 and 32.0 kg/m2 (inclusive) and body weight between 50 and 100 kg for males and between 45 and 100 kg for females.
- No clinically significant clinical laboratory values (Hematology, coagulation, biochemistry and urinalysis) at the discretion of the PI.
- Females of child bearing potential must use an acceptable, highly effective double contraception and have a negative pregnancy test at Screening and Day-1.
- Documented evidence of surgical sterilization at least 6 months prior to screening for women or vasectomy at least 90 days prior to screening.
Key exclusion criteria (21 listed)
- History or evidence of clinically significant condition, including but not limited to any cardiovascular, gastrointestinal, endocrinologic, hematologic, psychiatric, renal disease, musculoskeletal, infectious, or neurological condition or any chronic medical condition and/or other major disease, as determined by the PI.
- A PR < 40 or > 100 beats per minute, mean systolic blood pressure (SBP) > 140 mmHg, or mean diastolic blood pressure (DBP) > 95 mmHg .
- A mean corrected QT interval using Fridericia's formula (QTcF) interval at Screening > 450 ms in males and > 470 ms in females. If the mean QTcF exceeds these limits, one additional triplicate ECG will be performed.
- Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, in the judgment of the PI, may interfere with the interpretation of QTc-interval changes, including abnormal ST-T wave morphology or left ventricular hypertrophy.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or creatinine > 1.5 × the upper limit of the normal range (ULN) or total bilirubin or lymphocyte counts > ULN.
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 |
|---|---|---|
| PMG1015 Dose 1Also: PMG1015Dose level 1 of PMG1015 | Drug | Single Ascending Doses Cohort 1a |
| PMG1015 Dose 2Also: PMG1015Dose level 2 of PMG1015 | Drug | Single Ascending Doses Cohort 1b |
| PMG1015 Dose 3Also: PMG1015Dose level 3 of PMG1015 | Drug | Single Ascending Doses Cohort 1c |
| PMG1015 Dose 4Also: PMG1015Dose level 4 of PMG1015 | Drug | Single Ascending Doses Cohort 1d |
| PMG1015 Dose 5Also: PMG1015Dose level 5 of PMG1015 | Drug | Single Ascending Doses Cohort 1e |
| PMG1015 Dose 6Also: PMG1015Dose level 6 of PMG1015 | Drug | Single Ascending Doses Cohort 1f |
| PlaceboPlacebo to match | Drug | Single Ascending Doses Cohort 1a, Single Ascending Doses Cohort 1b, Single Ascending Doses Cohort 1c, Single Ascending Doses Cohort 1d, Single Ascending Doses Cohort 1e, Single Ascending Doses Cohort 1f, Single Ascending Doses Cohort 1g |
| PMG1015 Dose 7Also: PMG1015Dose level 7 of PMG1015 | Drug | Single Ascending Doses Cohort 1g |
Primary outcome
The incidence of Treatment-emergent adverse events (TEAEs)
Time frame: Day 1-Day 85
An Adverse Event (AE) is any event, side-effect or any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs are AEs that occur following the start of treatment.
The severity of Treatment-emergent adverse events (TEAEs)
Time frame: Day 1-Day 85
TEAEs are AEs that occur following the start of treatment.
The incidence of Serious adverse events (SAEs)
Time frame: Day 1-Day 85
A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of IP (active or placebo) that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect.
The severity of Serious adverse events (SAEs)
Time frame: Day 1- Day 85
A serious adverse event (SAE) is defined as an AE occurring during any study phase and at any dose of IP (active or placebo) that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect.
Number of participants with abnormally clinical vital signs
Time frame: Day 1- Day 85
Vital signs include pulse rate (PR), blood pressure (BP), respiratory rate (RR) and tympanic temperature (T)
Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters
Time frame: Day 1-Day 85.
All ECG tracings will be reviewed by the PI or designee and assessed for clinical significance.
Number of participants with abnormal clinically significant clinical laboratory results
Time frame: Day 1- Day 85
Clinical laboratory test include hematology, coagulation, biochemistry, and urinalysis.
MTD of PMG1015 in healthy participants
Time frame: Day 1- Day 85
Maximum tolerated dose of PMG1015 in healthy participants
Number of patients with abnormal clinically significant results from physical examination
Time frame: Day 1-Day 85
Complete physical examination include, general appearance, head, eyes, ears, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes.
10 secondary outcomes
Area under the serum-concentration time curve (AUC) from time zero (from the start of infusion time) to the last time point with measurable analyte concentration (AUC0-t)
Time frame: Day 1-Day 85.
AUC from time zero to infinity (AUC0-∞)
Time frame: Day 1-Day 85.
To determine %AUCexp
Time frame: Day 1-Day 85.
To determine Cmax
Time frame: Day 1-Day 85.
To determine Tmax, derived from serum concentration of each dose of PMG1015
Time frame: Day 1-Day 85.
To determine t1/2
Time frame: Day 1-Day 85.
Apparent total body clearance (CL)
Time frame: Day 1-Day 85.
Apparent volume of distribution during the terminal phase (Vz)
Time frame: Day 1-Day 85.
Apparent terminal elimination rate constant (λz or kel)
Time frame: Day 1-Day 85.
Levels of ADA
Time frame: Day 1-Day 85
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 31 Jan 2023.
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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.
Richard Friend principal investigator
Nucleus Network
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 PMG1015 Dose 1, PMG1015 Dose 2 and PMG1015 Dose 3 in people with Idiopathic Pulmonary Fibrosis, run by Pulmongene Ltd. at 1 site in Australia.
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 7 inclusion and 21 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 31 Jan 2023. 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 Australia. 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?
The incidence of Treatment-emergent adverse events (TEAEs) (time frame: Day 1-Day 85). The study lists 9 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 31 Jan 2023.