Type 2 DiabetesPhase 1NCT05385575
A Study to Evaluate Effects of KN056 in Healthy Participants
A Phase 1 study testing KN056 (0.1mg), KN056 (0.3mg) and KN056 (1.0mg) in people with Type 2 Diabetes, run by Suzhou Alphamab Co., Ltd. at 1 site in New Zealand.
Trial summary
This is a Phase 1, First-in-human, double-blinded, placebo-controlled study which aims to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the immunogenicity of KN056 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- KN056 (0.1mg), KN056 (0.3mg) and KN056 (1.0mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteNew Zealand
- Study dates
- 9 Aug 2022to 29 Feb 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
- Healthy male or female subjects (not be breastfeeding);
- Aged between 18 and 55 (including thresholds) at the time of signing Informed Consent Form;
- Body mass index (BMI) between 18.5 and 35.0 kg/m2 (excluding the threshold);
- 3.5mmol/L(63 mg/dL) less than or equal to Fasting blood glucose level less than 6.1mmol/L(110 mg/dL).
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures and are willing to follow study restrictions;
- Are able and willing to sign the ICF.
Who cannot join
- Those who have a history of chronic diseases or are currently suffering from obvious systemic diseases, such as diseases of cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, blood system, autoimmune system, neurological or psychiatric system, bacterial or viral infection;
- History or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis)
- History of GI disorder (for example, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (for example, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by GLP-1 analogs or DPP-IV inhibitors;
- Participants with dyslipidemia (Total Cholesterol more than 6mmol/L and/or Triglyceride more than or equal to 1.7 mmol/L);
- Participants had cholecystolithiasis (removal of gallstones) and/or cholecystectomy (removal of gall bladder) in the past;
- A personal or family history of medullary thyroid cancer or multiple endocrine adenoma syndrome type 2 (MEN2);
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- Allergies to GLP-1 analogues, or KN056 related compounds;
- A history of medicine abuse/dependence or narcotics abuse within 1 year prior to the screening and/or show positive findings on urinary drug screening;
- Previous alcoholism or have regular alcohol consumption (drinking more than 14 units of alcohol per week in the 3 months prior to the screening, are unwilling to stop alcohol consumption from at least 48 hours before landing in Phase I ward (D-2) to the end of discharge from the clinical research unit (CRU), or are unwilling to limit intake to a maximum of 2 units per day on all other days from screening through follow-up (1 unit =12oz or 360 mL of beer; 5oz or 150 mL of wine; 1.5oz or 45 mL of distilled spirits);
- Smokers who have smoked more than 10 cigarettes or equivalent in nicotine (e-cigarettes/vaping) daily within 3 months prior to screening or are unwilling to refrain from smoking on the day of drug administration or are unable to abide by clinical research unit (CRU) restrictions;
- Blood donation or blood loss ≥ 300 mL within 3 months prior to screening (except female physical blood loss), or blood/blood components donation planned during the trial or within 1 month after the final study visit;
- Those who participated in any drug/vaccine clinical trial, and the last administration of the trial was within 3 months or 5 half-lives of the drug/vaccine prior to dosing of study drug, whichever is longer;
- Received vaccination within 14 days prior to screening, or have vaccination schedule during the trial (from screening to the final visit), including inactivated vaccine, live attenuated vaccine, recombinant protein vaccine, recombinant adenovirus vaccine, RNA vaccine, DNA vaccine, COVID-19 vaccine;
- Use medication (including prescription drugs, over-the-counter drugs, herbal medicine) with the exception of vitamin/mineral supplements, paracetamol, topical medication, and contraceptives within 14 days prior to dosing;
- Have abnormal and clinically significant results of physical examination, vital signs, abdominal B-ultrasonography (liver, gallbladder, pancreas, spleen and kidneys) or thyroid B-ultrasonography, and may increases the risks associated with participating in the study;
- Have abnormal and clinically significant results of Hematology, Urinalysis, blood biochemistry, serum lipase, calcitonin, thyroid function and glycosylated hemoglobin (HbA1c>40mmol/mol (5.8%)) and may increases the risks of participants in the study;
- ECG shows increased heart rate (>100 beats/min), arrhythmia, significant QT/QTc interval prolongation (QTcF (Frederica values) >450ms for males and > 470ms for females) and other manifestations, which are clinically significant;
- Evidence of hepatitis B or positive hepatitis B surface antigen at screening; evidence of hepatitis C or hepatitis C antibody at screening; evidence of AIDS and/or positive HIV antibodies at screening; evidence of syphilis and/or syphilis test is positive at screening;
- The result of coronavirus nucleic acid test (COVID-19) is positive at screening or admission (Day-2)
- Participants that refuse to stay abstinent, and refuse to consistently use a form of highly effective birth control in combination with a barrier method if heterosexually active starting at Screening (signing the ICF) and continuing throughout the clinical study period, and to 3 months after administration of KN056 or Placebo, or participants tell that their partners refuse to do so;
- Examples of highly effective forms of contraception include:
- Implant contraceptive (e.g. Jadelle®)
- Intra-uterine device (IUD) containing either copper or levonorgestrel (e.g. Mirena®)
- Male sterilization (vasectomy)
- Female sterilization (e.g. bilateral tubal ligation ('clipping or tying tubes') or hysterectomy)
- Injectable contraceptive (e.g. Depo Provera)
- Oral Contraceptive Pill (combined hormonal contraceptive pill or progestogen-only 'mini-pill')
- These requirements do not apply to female participants in a same sex relationship and female participants of nonchildbearing potential.
- Female participants of nonchildbearing potential should meet one of the following conditions:
- Must have a confirmed clinical history of sterility (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, as confirmed by review of the subjects' medical records, medical examination, or medical history interview)
- Must be postmenopausal as defined as: amenorrhea for ≥ 12 months prior to screening and a laboratory confirmed serum follicle-stimulating hormone (FSH) level ≥ 40 IU/L at screening.
- Female participants of childbearing potential (no matter homosexuality or heterosexuality) with positive pregnancy test at Screening and Day -1;
- Participants that plan to donate sperms/eggs from dosing until 3 months after administration of KN056 or Placebo;
- Participants with any inappropriate factor for participation in this study considered by the investigator or sponsor;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind and Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN056 in Healthy Participants
This is a Phase 1, First-in-human, double-blinded, placebo-controlled study which aims to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the immunogenicity of KN056 in healthy participants.
Read the detailed description
KN056 is a biological innovative drug developed as a treatment for type 2 diabetes. It is a recombinant human Fc-fused GLP-1 variant protein. GLP-1 can activate the intracellular pathway to cause the elevation of cAMP, thereby promoting insulin secretion and inhibiting glucagon secretion.
The study will involve a single ascending (increasing) dose (SAD) study and will enroll up to 46 healthy participants across 7 dosing groups.
Cohort 1 - 0.1mg (2 participants, both receiving KN056 separated by at least 1 day) Cohort 2 - 0.3mg (4 participants, dosed as 2 +2, separated by a safety observation of at least 3 days) Cohort 3 - 1.0mg (6 participants receiving KN056 + 2 receiving placebo) Cohort 4 - 3.0mg (6 participants receiving KN056 + 2 receiving placebo) Cohort 5 - 6.0mg (6 participants receiving KN056 + 2 receiving placebo) Cohort 6 - 12.0mg (6 participants receiving KN056 + 2 receiving placebo) Cohort 7 - 18.0mg (6 participants receiving KN056 + 2 receiving placebo) In Cohort 3 to 6; the first 2 subjects will be as sentries, and will be injected with KN056 or placebo randomly: at least 3 days after 2 sentries' administration, the remaining 6 participants will be randomized to receive KN056 or placebo in a 5:1 ratio. Additional dose group: the number and randomization of Cohort 7 participants are identical to those in Cohort 3 to Cohort 6.
The dose will be given as a subcutaneous (SC) injection into the abdomen.
- Conditions
- Type 2 Diabetes
- Being tested
- KN056 (0.1mg), KN056 (0.3mg), KN056 (1.0mg), KN056 (3.0mg), KN056 (6.0mg)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN056 (0.1mg)Drug
The participants will receive assigned single dose of KN056 on Day 1
KN056 (0.3mg)Drug
The participants will receive assigned single dose of KN056 on Day 1
KN056 (1.0mg)Drug
The participants will receive assigned single dose of KN056 or placebo on Day 1
KN056 (3.0mg)Drug
The participants will receive assigned single dose of KN056 or placebo on Day 1
KN056 (6.0mg)Drug
The participants will receive assigned single dose of KN056 or placebo on Day 1
KN056 (12.0mg)Drug
The participants will receive assigned single dose of KN056 or placebo on Day 1
KN056 (18.0mg)Drug
The participants will receive assigned single dose of KN056 or placebo on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participant will receive 0.1mg of single dose by subcutaneous injection of KN056 Receives: Drug: KN056 (0.1mg) |
| Cohort 2 | Experimental | Participant will receive 0.3mg of single dose by subcutaneous injection of KN056 Receives: Drug: KN056 (0.3mg) |
| Cohort 3 | Experimental | Participant will receive 1.0mg of single dose by subcutaneous injection of KN056 or placebo Receives: Drug: KN056 (1.0mg) |
| Cohort 4 | Experimental | Participant will receive 3.0mg single subcutaneous dose of KN056 or placebo Receives: Drug: KN056 (3.0mg) |
| Cohort 5 | Experimental | Participant will receive 6.0mg of single dose by subcutaneous injection of KN056 or placebo Receives: Drug: KN056 (6.0mg) |
| Cohort 6 | Experimental | Participant will receive 12.0mg of single dose by subcutaneous injection of KN056 or placebo Receives: Drug: KN056 (12.0mg) |
| Cohort 7 | Experimental | Participant will receive 18.0mg of single dose by subcutaneous injection of KN056 or placebo Receives: Drug: KN056 (18.0mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment-emergent adverse events (TEAEs) and treatment related (TRAEs). TEAEs will be measured as per the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.
Measured: Up to 45 days
Severity of TEAEs and treatment related TEAEs. TEAEs will be measured as per the Common Terminology Criteria for (CTCAE) v5.0
Measured: Up to 45 days
Number of participants with abnormal clinically significant laboratory results.
Clinical laboratory includes hematology, biochemistry, lipase, calcitonin, thyroid function, Abdominal and thyroid B-ultrasonography, and urinalysis.
Measured: Up to 45 days
Number of participants with abnormal clinically significant vital signs.
Vital signs include Includes blood pressure (systolic and diastolic), respiration, temperature and pulse.
Measured: Up to 45 days
Number of participants with abnormal clinically significant electrocardiogram (ECG)
12-lead ECG will be performed.
Measured: Up to 45 days
Secondary outcomes (5)
To evaluate the pharmacokinetic parameters of KN056. Pharmacokinetic parameters will be estimated using non-compartment model analysis with Phoenix WinNolin 8.0
Parameters: AUC0-last, AUC0-inf, MRT, Tmax, Cmax or above and T1/2, CL/F, Vz/F and so on.
Measured: Day 1, Day 7, Day 14, Day 21, Day 28, Day 42
Immunogenicity of KN056
The immunogenicity of KN056 will be evaluated by detection of ADA, and ADA titer and NAb will be detected in ADA positive samples
Measured: Up to 45 days
The efficacy of KN056 by analyzing fasting blood glucose
Measured: Up to 45 days
The efficacy of KN056 through Oral Glucose Tolerance test (OGTT)
Measured: Up to 45 days
The efficacy of KN056 by analyzing HbA1c (Glycosylated hemoglobin) changes
Measured: Up to 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start9 Aug 2022
- Primary completion22 Dec 2023
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Alphamab Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Alexandra Cole, Principal investigator, New Zealand Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385575
- Sponsor's protocol ID
- KN056-A-101
- Status last verified
- Aug 2023
- First submitted
- 18 May 2022
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind and Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of KN056 in Healthy Participants
- ClinicalTrials.gov ID
- NCT05385575
- Acronym / sponsor ID
- KN056-A-101
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Suzhou Alphamab Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 9 Aug 2022 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 23 May 2022 (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 1, First-in-human, double-blinded, placebo-controlled study which aims to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the immunogenicity of KN056 in healthy participants.
Detailed description
KN056 is a biological innovative drug developed as a treatment for type 2 diabetes. It is a recombinant human Fc-fused GLP-1 variant protein. GLP-1 can activate the intracellular pathway to cause the elevation of cAMP, thereby promoting insulin secretion and inhibiting glucagon secretion.
The study will involve a single ascending (increasing) dose (SAD) study and will enroll up to 46 healthy participants across 7 dosing groups.
Cohort 1 - 0.1mg (2 participants, both receiving KN056 separated by at least 1 day) Cohort 2 - 0.3mg (4 participants, dosed as 2 +2, separated by a safety observation of at least 3 days) Cohort 3 - 1.0mg (6 participants receiving KN056 + 2 receiving placebo) Cohort 4 - 3.0mg (6 participants receiving KN056 + 2 receiving placebo) Cohort 5 - 6.0mg (6 participants receiving KN056 + 2 receiving placebo) Cohort 6 - 12.0mg (6 participants receiving KN056 + 2 receiving placebo) Cohort 7 - 18.0mg (6 participants receiving KN056 + 2 receiving placebo) In Cohort 3 to 6; the first 2 subjects will be as sentries, and will be injected with KN056 or placebo randomly: at least 3 days after 2 sentries' administration, the remaining 6 participants will be randomized to receive KN056 or placebo in a 5:1 ratio. Additional dose group: the number and randomization of Cohort 7 participants are identical to those in Cohort 3 to Cohort 6.
The dose will be given as a subcutaneous (SC) injection into the abdomen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: KN056 (0.1mg)Participant will receive 0.1mg of single dose by subcutaneous injection of KN056 |
| Cohort 2 | Experimental | Drug: KN056 (0.3mg)Participant will receive 0.3mg of single dose by subcutaneous injection of KN056 |
| Cohort 3 | Experimental | Drug: KN056 (1.0mg)Participant will receive 1.0mg of single dose by subcutaneous injection of KN056 or placebo |
| Cohort 4 | Experimental | Drug: KN056 (3.0mg)Participant will receive 3.0mg single subcutaneous dose of KN056 or placebo |
| Cohort 5 | Experimental | Drug: KN056 (6.0mg)Participant will receive 6.0mg of single dose by subcutaneous injection of KN056 or placebo |
| Cohort 6 | Experimental | Drug: KN056 (12.0mg)Participant will receive 12.0mg of single dose by subcutaneous injection of KN056 or placebo |
| Cohort 7 | Experimental | Drug: KN056 (18.0mg)Participant will receive 18.0mg of single dose by subcutaneous injection of KN056 or placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male or female subjects (not be breastfeeding);
- Aged between 18 and 55 (including thresholds) at the time of signing Informed Consent Form;
- Body mass index (BMI) between 18.5 and 35.0 kg/m2 (excluding the threshold);
- 3.5mmol/L(63 mg/dL) less than or equal to Fasting blood glucose level less than 6.1mmol/L(110 mg/dL).
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures and are willing to follow study restrictions;
Key exclusion criteria (34 listed)
- Those who have a history of chronic diseases or are currently suffering from obvious systemic diseases, such as diseases of cardiovascular system, respiratory system, endocrine and metabolic system, urinary system, digestive system, blood system, autoimmune system, neurological or psychiatric system, bacterial or viral infection;
- History or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis)
- History of GI disorder (for example, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (for example, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by GLP-1 analogs or DPP-IV inhibitors;
- Participants with dyslipidemia (Total Cholesterol more than 6mmol/L and/or Triglyceride more than or equal to 1.7 mmol/L);
- Participants had cholecystolithiasis (removal of gallstones) and/or cholecystectomy (removal of gall bladder) in the past;
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 |
|---|---|---|
| KN056 (0.1mg)The participants will receive assigned single dose of KN056 on Day 1 | Drug | Cohort 1 |
| KN056 (0.3mg)The participants will receive assigned single dose of KN056 on Day 1 | Drug | Cohort 2 |
| KN056 (1.0mg)The participants will receive assigned single dose of KN056 or placebo on Day 1 | Drug | Cohort 3 |
| KN056 (3.0mg)The participants will receive assigned single dose of KN056 or placebo on Day 1 | Drug | Cohort 4 |
| KN056 (6.0mg)The participants will receive assigned single dose of KN056 or placebo on Day 1 | Drug | Cohort 5 |
| KN056 (12.0mg)The participants will receive assigned single dose of KN056 or placebo on Day 1 | Drug | Cohort 6 |
| KN056 (18.0mg)The participants will receive assigned single dose of KN056 or placebo on Day 1 | Drug | Cohort 7 |
Primary outcome
Number of treatment-emergent adverse events (TEAEs) and treatment related (TRAEs). TEAEs will be measured as per the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.
Time frame: Up to 45 days
Severity of TEAEs and treatment related TEAEs. TEAEs will be measured as per the Common Terminology Criteria for (CTCAE) v5.0
Time frame: Up to 45 days
Number of participants with abnormal clinically significant laboratory results.
Time frame: Up to 45 days
Clinical laboratory includes hematology, biochemistry, lipase, calcitonin, thyroid function, Abdominal and thyroid B-ultrasonography, and urinalysis.
Number of participants with abnormal clinically significant vital signs.
Time frame: Up to 45 days
Vital signs include Includes blood pressure (systolic and diastolic), respiration, temperature and pulse.
Number of participants with abnormal clinically significant electrocardiogram (ECG)
Time frame: Up to 45 days
12-lead ECG will be performed.
5 secondary outcomes
To evaluate the pharmacokinetic parameters of KN056. Pharmacokinetic parameters will be estimated using non-compartment model analysis with Phoenix WinNolin 8.0
Time frame: Day 1, Day 7, Day 14, Day 21, Day 28, Day 42
Immunogenicity of KN056
Time frame: Up to 45 days
The efficacy of KN056 by analyzing fasting blood glucose
Time frame: Up to 45 days
The efficacy of KN056 through Oral Glucose Tolerance test (OGTT)
Time frame: Up to 45 days
The efficacy of KN056 by analyzing HbA1c (Glycosylated hemoglobin) changes
Time frame: Up to 45 days
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 30 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Alexandra Cole principal investigator
New Zealand Clinical Research
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 KN056 (0.1mg), KN056 (0.3mg) and KN056 (1.0mg) in people with Type 2 Diabetes, run by Suzhou Alphamab Co., Ltd. at 1 site in New Zealand.
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 34 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 30 Dec 2024. 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 New Zealand. 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 treatment-emergent adverse events (TEAEs) and treatment related (TRAEs). TEAEs will be measured as per the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0. (time frame: Up to 45 days). The study lists 5 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 30 Dec 2024.