HealthyPhase 1NCT06360874
A Study to Evaluate Safety, Tolerability and Pharmacokinetic of ND-003 Tablets in Healthy Adults
A Phase 1 study testing ND-003 40mg, ND-003 80mg and ND-003 160mg in people with Healthy, run by Shenzhen NewDEL Biotech, Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to evaluate Safety, Tolerability and Pharmacokinetic of ND-003 tablets in Healthy Adults Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ND-003 40mg, ND-003 80mg and ND-003 160mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 9 May 2024to Feb 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1) Healthy volunteers, both male and female;
- 2) age: 18-45 years old;
- 3) Weight: Male ≥ 50kg, female ≥ 45kg, 19 ≤ BMI ≤ 26 (BMI=weight (kg)/height2 (m2);
- 4) Subject is in generally good health according to physical examination;
- 5) Subjects voluntarily participate in clinical trials and sign a written informed consent form.
Who cannot join
- 1) Participated in any other clinical trial of drugs within the three months prior to the trial;
- 2) Any disease that may affect the safety of the clinical trial or the in vivo process of the investigational drug;
- 3) Allergic constitution: If there is a history of drug, food allergies, or skin allergies;
- 4) Any drug that inhibits or induces liver metabolism has been used within 28 days prior to the use of the investigational drug;
- 5) Have used any medication (including Chinese herbal medicine) and health supplements within 14 days prior to administration;
- 6) Have special requirements for diet and cannot follow a unified diet;
Show all 23Show fewer
- 7) Subjects with a history of intolerance to venipuncture blood collection, or fear of needles and hemophobia;
- 8) Drinking alcohol, tea, or caffeinated beverages for a long period of time or within 48 hours prior to administration;
- 9) Previous alcoholics, or frequent alcohol consumption within 6 months prior to administration; or consumption of any alcohol-containing product within 24 hours prior to administration ;
- 10) Blood donation or blood loss (greater than 450 mL) within 3 months prior to administration, or planning to donate blood during the study period or within 3 months after the end of the study ;
- 11) Acute illness occurred during pre study screening or prior to administration;
- 12) Subjects who have any diet that can alter liver enzymes activity within 24 hours prior to administration;
- 13) Have undergone surgery within the first three months of screening, or plan to undergo surgery during the study period;
- 14) Previous drug addict and drug abuse;
- 15) Smoking more than 5 cigarettes per day within the first 14 days of screening, or unable to withdraw nicotine-containing products during the study;
- 16) Subjects who smoke or use nicotine-containing products from screening to hospitalization;
- 17) Abnormal and clinically significant electrocardiogram results before screening or administration, or QTcF(QTcF - Fridericia's correction formula)>450 msec;
- 18) Positive results of nicotine test;
- 19) Alcohol breath test, with test results greater than 0.0mg/100 mL;
- 20) Positive urine drug test at screening;
- 21) Pregnant or lactating women;
- 22) Have plan for fertility or reluctance use any contraception during the study period and within 6 months after the end of the trial;
- 23) Subjects with other factors that are not suitable for participation in this study as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Food Effect of ND-003 Tablets in Healthy Adult Volunteers
The purpose of this study is to evaluate Safety, Tolerability and Pharmacokinetic of ND-003 tablets in Healthy Adults
Read the detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability and Pharmacokinetic of of ND-003 in healthy adults volunteers, and then evaluate food effects.
The study will be conducted in three parts: Part A-Single ascending dose (SAD) , Part B-Multiple ascending dose (MAD) and Part C-Food Effect. Each subject will be enrolled in only one cohort of either Parts A or B or C of the study, to receive only one dose regimen during the study.
- Conditions
- Healthy
- Being tested
- ND-003 40mg, ND-003 placebo 40mg, ND-003 80mg, ND-003 placebo 80mg, ND-003 160mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ND-003 40mgDrug
Participants receive 40mg ND-003 tablets once.
ND-003 placebo 40mgDrug
Participants receive placebo tablet matching to receive 40mg of ND-003.
ND-003 80mgDrug
Participants receive 80mg ND-003 tablets once.
ND-003 placebo 80mgDrug
Participants receive placebo tablet matching to receive 80mg of ND-003.
ND-003 160mgDrug
Participants receive 160mg ND-003 tablets once.
ND-003 placebo 160mgDrug
Participants receive placebo tablet matching to receive 160mg of ND-003.
ND-003 240mgDrug
Participants receive 240mg ND-003 tablets once.
ND-003 placebo 240mgDrug
Participants receive placebo tablet matching to receive 240mg of ND-003.
ND-003 300mgDrug
Participants receive 300mg ND-003 tablets once.
ND-003 placebo 300mgDrug
Participants receive placebo tablet matching to receive 300mg of ND-003.
MAD_ND003_Dose 1Drug
Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.
MAD_placebo_Dose 1Drug
Participants will orally administrated the placebo tablets matching to the MAD_ND003_Dose 1
MAD_ND003_Dose 2Drug
Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.
MAD_placebo_Dose 2Drug
Participants will orally administrated the placebo tablets matching to the MAD_ND003_Dose 2
MAD_ND003_Dose 3Drug
Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD.
MAD_ placebo_Dose 3Drug
Participants will orally administrated the placebo tablets matching to the MAD_ND003_Dose 3
Food effect_Cohort 1Drug
Firstly orally administrated ND-003 tablets in fast state and then in fed state after a 7-day washout period. Wherein, the dose will be determined based on the results of SAD and MAD.
Food effect_Cohort 2Drug
Firstly orally administrated ND-003 tablets in fed state and then in fast state after a 7-day washout period. Wherein, the dose will be determined based on the results of SAD and MAD.
| Study group | Role | What they receive |
|---|---|---|
| ND-003 40mg | Experimental | SAD（Single Ascending Dose） Cohort 1: Participants were orally administered 40mg of ND-003 or matched placebo once. Receives: Drug: ND-003 40mg; Drug: ND-003 placebo 40mg |
| ND-003 80mg | Experimental | SAD Cohort 2: Participants were orally administered 80mg of ND-003 or matched placebo once. Receives: Drug: ND-003 80mg; Drug: ND-003 placebo 80mg |
| ND-003 160mg | Experimental | SAD Cohort 3: Participants were orally administered 160mg of ND-003 or matched placebo once. Receives: Drug: ND-003 160mg; Drug: ND-003 placebo 160mg |
| ND-003 240mg | Experimental | SAD Cohort 4: Participants were orally administered 240mg of ND-003 or matched placebo once. Receives: Drug: ND-003 240mg; Drug: ND-003 placebo 240mg |
| ND-003 300mg | Experimental | SAD Cohort 5: Participants were orally administered 300mg of ND-003 or matched placebo once. Receives: Drug: ND-003 300mg; Drug: ND-003 placebo 300mg |
| ND-003_Dose 1 | Experimental | MAD （Multiple Ascending Dose）Cohort 1:The dose of ND-003 or matched placebo will be determined based on the results of the SAD. Three dose cohorts will be set and the volunteers will receive the drug once a day for 7 consecutive days. Receives: Drug: MAD_ND003_Dose 1; Drug: MAD_placebo_Dose 1 |
| ND-003_Dose 2 | Experimental | MAD Cohort 2: The dose of ND-003 or matched placebo will be determined based on the results of the SAD. Three dose cohorts will be set and the volunteers will receive the drug once a day for 7 consecutive days. Receives: Drug: MAD_ND003_Dose 2; Drug: MAD_placebo_Dose 2 |
| ND-003_Dose 3 | Experimental | MAD Cohort 3:The dose of ND-003 or matched placebo will be determined based on the results of the SAD. Three dose cohorts will be set and the volunteers will receive the drug once a day for 7 consecutive days. Receives: Drug: MAD_ND003_Dose 3; Drug: MAD_ placebo_Dose 3 |
| Food effect_Cohort 1 | Experimental | Food effect Cohort 1: The dose of ND-003 tablets will be determined based on the results of the SAD and MAD. Participants will be orally administered in fasting condition in day 1 and then in fed condition in day 8. Receives: Drug: Food effect_Cohort 1 |
| Food effect_Cohort 2 | Experimental | Food effect Cohort 2: The dose of ND-003 tablets will be determined based on the results of the SAD and MAD. Participants will be orally administered in fed condition in day 1 and then in fasting condition in day 8. Receives: Drug: Food effect_Cohort 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events (AE)
Number and type of participants with treatment-related adverse events
Measured: through study completion, an average of 1 month
Secondary outcomes (5)
maximum concentration (Cmax)
The drug maximum concentration reaches when the absorption rate is equal to the elimination rate at a single dose.
Measured: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Time to maximum concentration (Tmax)
Time required to reach peak drug concentration after a single administration.
Measured: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Elimination Half-life (t1/2)
Elimination Half-life (t1/2) refers to the time required to eliminate 50% of the drug from the body.
Measured: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Clearance (CLz/F)
Clearance (CLz/F) describes how the body effectively eliminate drugs from the systemic circulation, typically defined as the volume of drug-containing plasma eliminated from the body per unit time.
Measured: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
AUC from time 0 to last time of quantifiable concentration (AUC0-t)
Area under the plasma concentration-time curve from the initial administration to the last measurable concentration point.
Measured: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start9 May 2024
- Primary completionDec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen NewDEL Biotech, Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shenzhen Innovation Center for Small Molecule Drug Discovery Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Shaojun Shi, PhD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360874
- Sponsor's protocol ID
- ND003-I-06
- Status last verified
- Mar 2024
- First submitted
- 28 Mar 2024
- Last updated
- 30 May 2024
- 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 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Food Effect of ND-003 Tablets in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06360874
- Acronym / sponsor ID
- ND003-I-06
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Shenzhen NewDEL Biotech, Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Shenzhen Innovation Center for Small Molecule Drug Discovery Co., Ltd.
- Study start
- 9 May 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 11 Apr 2024 (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 study is to evaluate Safety, Tolerability and Pharmacokinetic of ND-003 tablets in Healthy Adults
Detailed description
This is a Phase 1, randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability and Pharmacokinetic of of ND-003 in healthy adults volunteers, and then evaluate food effects.
The study will be conducted in three parts: Part A-Single ascending dose (SAD) , Part B-Multiple ascending dose (MAD) and Part C-Food Effect. Each subject will be enrolled in only one cohort of either Parts A or B or C of the study, to receive only one dose regimen during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| ND-003 40mg | Experimental | Drug: ND-003 40mg, Drug: ND-003 placebo 40mgSAD（Single Ascending Dose） Cohort 1: Participants were orally administered 40mg of ND-003 or matched placebo once. |
| ND-003 80mg | Experimental | Drug: ND-003 80mg, Drug: ND-003 placebo 80mgSAD Cohort 2: Participants were orally administered 80mg of ND-003 or matched placebo once. |
| ND-003 160mg | Experimental | Drug: ND-003 160mg, Drug: ND-003 placebo 160mgSAD Cohort 3: Participants were orally administered 160mg of ND-003 or matched placebo once. |
| ND-003 240mg | Experimental | Drug: ND-003 240mg, Drug: ND-003 placebo 240mgSAD Cohort 4: Participants were orally administered 240mg of ND-003 or matched placebo once. |
| ND-003 300mg | Experimental | Drug: ND-003 300mg, Drug: ND-003 placebo 300mgSAD Cohort 5: Participants were orally administered 300mg of ND-003 or matched placebo once. |
| ND-003_Dose 1 | Experimental | Drug: MAD_ND003_Dose 1, Drug: MAD_placebo_Dose 1MAD （Multiple Ascending Dose）Cohort 1:The dose of ND-003 or matched placebo will be determined based on the results of the SAD. Three dose cohorts will be set and the volunteers will receive the drug once a day for 7 consecutive days. |
| ND-003_Dose 2 | Experimental | Drug: MAD_ND003_Dose 2, Drug: MAD_placebo_Dose 2MAD Cohort 2: The dose of ND-003 or matched placebo will be determined based on the results of the SAD. Three dose cohorts will be set and the volunteers will receive the drug once a day for 7 consecutive days. |
| ND-003_Dose 3 | Experimental | Drug: MAD_ND003_Dose 3, Drug: MAD_ placebo_Dose 3MAD Cohort 3:The dose of ND-003 or matched placebo will be determined based on the results of the SAD. Three dose cohorts will be set and the volunteers will receive the drug once a day for 7 consecutive days. |
| Food effect_Cohort 1 | Experimental | Drug: Food effect_Cohort 1Food effect Cohort 1: The dose of ND-003 tablets will be determined based on the results of the SAD and MAD. Participants will be orally administered in fasting condition in day 1 and then in fed condition in day 8. |
| Food effect_Cohort 2 | Experimental | Drug: Food effect_Cohort 2Food effect Cohort 2: The dose of ND-003 tablets will be determined based on the results of the SAD and MAD. Participants will be orally administered in fed condition in day 1 and then in fasting condition in day 8. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1) Healthy volunteers, both male and female;
- 2) age: 18-45 years old;
- 3) Weight: Male ≥ 50kg, female ≥ 45kg, 19 ≤ BMI ≤ 26 (BMI=weight (kg)/height2 (m2);
- 4) Subject is in generally good health according to physical examination;
- 5) Subjects voluntarily participate in clinical trials and sign a written informed consent form.
Key exclusion criteria (23 listed)
- 1) Participated in any other clinical trial of drugs within the three months prior to the trial;
- 2) Any disease that may affect the safety of the clinical trial or the in vivo process of the investigational drug;
- 3) Allergic constitution: If there is a history of drug, food allergies, or skin allergies;
- 4) Any drug that inhibits or induces liver metabolism has been used within 28 days prior to the use of the investigational drug;
- 5) Have used any medication (including Chinese herbal medicine) and health supplements within 14 days prior to administration;
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 |
|---|---|---|
| ND-003 40mgParticipants receive 40mg ND-003 tablets once. | Drug | ND-003 40mg |
| ND-003 placebo 40mgParticipants receive placebo tablet matching to receive 40mg of ND-003. | Drug | ND-003 40mg |
| ND-003 80mgParticipants receive 80mg ND-003 tablets once. | Drug | ND-003 80mg |
| ND-003 placebo 80mgParticipants receive placebo tablet matching to receive 80mg of ND-003. | Drug | ND-003 80mg |
| ND-003 160mgParticipants receive 160mg ND-003 tablets once. | Drug | ND-003 160mg |
| ND-003 placebo 160mgParticipants receive placebo tablet matching to receive 160mg of ND-003. | Drug | ND-003 160mg |
| ND-003 240mgParticipants receive 240mg ND-003 tablets once. | Drug | ND-003 240mg |
| ND-003 placebo 240mgParticipants receive placebo tablet matching to receive 240mg of ND-003. | Drug | ND-003 240mg |
| ND-003 300mgParticipants receive 300mg ND-003 tablets once. | Drug | ND-003 300mg |
| ND-003 placebo 300mgParticipants receive placebo tablet matching to receive 300mg of ND-003. | Drug | ND-003 300mg |
| MAD_ND003_Dose 1Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD. | Drug | ND-003_Dose 1 |
| MAD_placebo_Dose 1Participants will orally administrated the placebo tablets matching to the MAD_ND003_Dose 1 | Drug | ND-003_Dose 1 |
| MAD_ND003_Dose 2Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD. | Drug | ND-003_Dose 2 |
| MAD_placebo_Dose 2Participants will orally administrated the placebo tablets matching to the MAD_ND003_Dose 2 | Drug | ND-003_Dose 2 |
| MAD_ND003_Dose 3Participants will orally administrated the ND-003 tablets once a day , in which the dose will be determined based on the results of SAD. | Drug | ND-003_Dose 3 |
| MAD_ placebo_Dose 3Participants will orally administrated the placebo tablets matching to the MAD_ND003_Dose 3 | Drug | ND-003_Dose 3 |
| Food effect_Cohort 1Firstly orally administrated ND-003 tablets in fast state and then in fed state after a 7-day washout period. Wherein, the dose will be determined based on the results of SAD and MAD. | Drug | Food effect_Cohort 1 |
| Food effect_Cohort 2Firstly orally administrated ND-003 tablets in fed state and then in fast state after a 7-day washout period. Wherein, the dose will be determined based on the results of SAD and MAD. | Drug | Food effect_Cohort 2 |
Primary outcome
Adverse Events (AE)
Time frame: through study completion, an average of 1 month
Number and type of participants with treatment-related adverse events
5 secondary outcomes
maximum concentration (Cmax)
Time frame: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Time to maximum concentration (Tmax)
Time frame: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Elimination Half-life (t1/2)
Time frame: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Clearance (CLz/F)
Time frame: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
AUC from time 0 to last time of quantifiable concentration (AUC0-t)
Time frame: Pre-dose 60 minutes and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 36, 48, 72, 96 hours post-dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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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.
Shaojun Shi, PhD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 ND-003 40mg, ND-003 80mg and ND-003 160mg in people with Healthy, run by Shenzhen NewDEL Biotech, Co., Ltd at 1 site in China.
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 23 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: status not confirmed, as of the sponsor's last update on 30 May 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 China. 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?
Results are not available in the source record.
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?
Adverse Events (AE) (time frame: through study completion, an average of 1 month). 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 May 2024.