Vasomotor System; LabilePhase 1NCT06385158
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Dose Escalation of GS1-144 Tablets and the Effects of Food on the Pharmacokinetics of GS1-144 in a Chinese Population
A Phase 1 study testing GS1-144 tablet in people with Vasomotor System; Labile and Healthy Volunteer, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
A Phase I clinical study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral dose escalation of GS1-144 tablets and the effects of food on the pharmacokinetics of GS1-144 in a Chinese population Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vasomotor System; Labile, Healthy Volunteer
- What is being tested?
- GS1-144 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 3 Jan 2024to 5 Nov 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At the time of signing the informed consent form (ICF):
- Part 1and Part 2 only: healthy male and female subjects aged between 18 and 45 years inclusive; Part 3 only: healthy women aged between 40 and 65 years inclusive who have undergone natural menopause (natural menopause is defined as surgically sterile (hysterectomy, bilateral salpingectomy, tubal ligation or bilateral oophorectomy - verbal confirmation through medical history review acceptable) or postmenopausal (no menses for 12 months and confirmed by FSH level ≥40 mlU/mL);
- Body weight ≥ 50 kg (male), ≥ 45 kg (female) with a body mass index between 19.0 and 27.9 kg/m2 inclusive at screening
- From signing the ICF to 1 month (female subjects) /3 months (male subjects and their female partners) after the end of the study, no family planning and egg/sperm donation plans, and effective contraceptive methods (such as IUD, bilateral tubal/vasectomy, condom and safe period calculation, etc.) (applicable to Parts 1 and 2)' ' ● Volunteer to sign ICF and be able to understand and comply with the requirements of this study
Who cannot join
- Any known allergy to the components or analogues of the investigational product, or those with an allergic constitution (such as allergy to two or more drugs or foods)；
- A history of currently suffering from any other cardiovascular, gastrointestinal, endocrine, hematological, hepatic, immunological, metabolic, urinary, pulmonary, neurological, dermatological, psychiatric, renal and/or other major diseases deemed clinically significant by the investigator;
- Known/confirmed history of malignancy；
- A history of epileptic seizure or increased risk of epileptic seizure, or subjects with a recent history (within six months prior to screening) of head trauma leading to loss of consciousness or concussion;
- A history of currently suffering from hypothalamic dysfunction;
- Significant acute/chronic infections within two weeks prior to dosing;
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- Undergone major surgical procedures (such as coronary artery bypass grafting, organ resection, gynecological surgery, etc.) within six months prior to screening or plan to undergo any surgery during the trial;
- Participated in other clinical trials (except those who have not received any intervention) within 3 months prior to dosing, Or are participating in other clinical trials.
- Have lost or donated more than 400 mL of blood within 3 months prior to screening;
- Have taken any prescription/over-the-counter drugs or dietary supplements ,within 7 days prior to dosing or within 5 half-lives of the drug (whichever is longer);
- Clinically significant abnormalities on physical examination or genitourinary ultrasound at the time of screening;
- Clinically significant abnormalities in vital signs, where the criteria for clinically significant blood pressure abnormalities are defined as systolic blood pressure ≥ 140 mmHg or < 90 mmHg, and diastolic blood pressure ≥ 90 mmHg or < 60 mmHg;
- Prolonged QTcF interval in 12-lead ECG results (> 450 ms for males, > 470 ms for females) or clinically significant abnormalities in other 12-lead ECG parameters at screening;
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT), total bilirubin (TBIL), blood creatinine (CRE), blood urea nitrogen (BUN), or international normalized ratio (INR) higher than the upper limit of normal (ULN) at screening, that are considered as clinically significant abnormalities by the investigator;
- Part 3 only: abnormal sex hormone levels at screening that are considered clinically significant by the investigator;
- Clinically significant abnormalities in thyroid function, parathyroid function, and neck ultrasound results at screening;
- Women with positive pregnancy test result or those who are breastfeeding before dosing;
- Positive hepatitis C virus antibody (HCV Ab), positive human immunodeficiency virus antibody (HIV Ab) or positive hepatitis B surface antigen (HbsAg) result at screening;
- Unable to refrain from consuming grapefruit, pomelo, grapefruit juice, or pomelo juice from 7 days prior to dosing until the end of the study;
- Unable to refrain from consuming any foods or beverages containing caffeine or xanthine (such as coffee, strong tea, chocolate, etc.) from 7 days prior to dosing until the end of the study;
- Unable to abstain from smoking/using tobacco products from 7 days prior to dosing until the end of the study, or positive urine cotinine test result before dosing
- Unable to refrain from consuming alcohol from 7 days prior to dosing until the end of the study, or positive breath alcohol test result before dosing;
- Any history of narcotic use or drug abuse, or positive urine drug screening result before dosing;
- Any medical or other condition, in the opinion of the investigator, may affect the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
A Phase I clinical study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral dose escalation of GS1-144 tablets and the effects of food on the pharmacokinetics of GS1-144 in a Chinese population
Read the detailed description
The primary purpose of this study is to assess the safety and tolerability of single ascending doses of GS1-144 in healthy participants in Part 1 and assessing the food effect in Part 2,and to assess the safety and tolerability of multiple ascending doses of GS1-144 in healthy postmenopausal female participants in Part 3.
- Conditions
- Vasomotor System; Labile, Healthy Volunteer
- Being tested
- GS1-144 tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS1-144 tabletDrug
GS1-144 tablet is an NK3R antagonist.
| Study group | Role | What they receive |
|---|---|---|
| GS1-144 tablet | Experimental | Not described Receives: Drug: GS1-144 tablet |
| placebo controlled study | Placebo comparator | Not described Receives: Drug: GS1-144 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1:Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Number of participants with TEAEs and SAEs will be reported
Measured: Up to Day 4
Part 2: Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Number of participants with TEAEs and SAEs will be reported.
Measured: Up to Day 9;
Part 3: Number of Participants With TEAEs and SAEs
Number of female post-menopausal participants with TEAEs and SAEs will be reported.
Measured: Up to Day 12
Secondary outcomes (16)
Part1,Part2 and Part3 AUC0-t- Area Under the Drug Concentration-time Curve From Time 0 to the Last Sample Collection Time t for GS1-144
AUC0-t will be assessed and reported.
Measured: Part 1 Day 1- pre-dose and up to 72 hour post-dose; Part 2 Days 1 and 6-pre-dose and up to 72 hour post-dose, Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose,
Part 1 , Part2 and Part 3: AUC0-infinity- Area Under the Drug Concentration-time Curve From 0 to Infinity for GS1-144
AUC0-infinity will be assessed and reported.
Measured: Part 1 Day 1- pre-dose and up to 72 hour post-dose; Part 2 Days 1 and 6-pre-dose and up to 72 hour post-dose, Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose,
Part 1, Part2 and Part 3: Cmax- Maximum Observed Plasma Concentration for GS1-144
Cmax will be assessed and reported.
Measured: Part 1 Day 1- pre-dose and up to 72 hour post-dose; Part 2 Days 1 and 6-pre-dose and up to 72 hour post-dose, Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose,
Part 1 Part2 and Part 3: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for GS1-144
Tmax will be assessed and reported.
Measured: Part 1 Day 1- pre-dose and up to 24 hour post-dose; Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Part 1 Part2 and Part 3:: T1/2- Terminal Half-life for GS1-144
T1/2 will be assessed and reported.
Measured: Time Frame: Part 1 Day 1- pre-dose and up to 72 hour post-dose; Part 2 Days 1 and 6-pre-dose and up to 72 hour post-dose, Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Part 1 Part2 and Part 3: CL/F- Apparent Clearance for GS1-144
CL/F will be assessed and reported.
Measured: Part 1 Day 1- pre-dose and up to 72 hour post-dose; Part 2 Days 1 and 6-pre-dose and up to 72 hour post-dose, Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Part 1 Part2 and Part 3: Vd/F- Apparent Volume of Distribution for GS1-144
Vd/F will be assessed and reported.
Measured: Part 1 Day 1- pre-dose and up to 72 hour post-dose; Part 2 Days 1 and 6-pre-dose and up to 72 hour post-dose, Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Cmax,ss- Observed Maximum Concentration at Steady State for GS1-144
Cmax at steady state will be assessed and reported.
Measured: Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Part 3: Cmin,ss- Observed Minimum Concentration at Steady State for GS1-144
Cmin at steady state will be assessed and reported.
Measured: Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Part 3: Tmax,ss- Time of Cmax at Steady State for GS1-144
Tmax at steady state will be assessed and reported.
Measured: Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Part 3: Cavg,ss- Average Concentration at Steady State for GS1-144
Cavg at steady state will be assessed and reported.
Measured: Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Part 3: AUC0-τ- Area Under the Drug Concentration-time Curve During the Dosing Interval at Steady State for GS1-144
AUC0-T at steady state will be assessed and reported.
Measured: Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Part 3: CLss/F- CL for Bioavailability at Steady State for GS1-144
CL/F at steady state will be assessed and reported.
Measured: Part 3 Days 1 and 7-pre-dose and up to 30 hour post-dose
Part 3: T1/2,ss- Terminal Half-life at Steady State for GS1-144
T1/2 at steady state will be assessed and reported.
Measured: Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Part 3: Accumulation Ratio for GS1-144
Accumulation Ratio will be assessed and reported.
Measured: Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Part 1: Baseline and placebo-adjusted changes in ∆∆QTc and other ECG parameters after oral administration of GF1-144 in healthy subjects
Measured: Part 1 Day 1- pre-dose and up to 24 hour post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start3 Jan 2024
- Primary completion6 Jan 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor System; LabileStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385158
- Sponsor's protocol ID
- GenSci074-101
- Status last verified
- May 2025
- First submitted
- 11 Apr 2024
- Last updated
- 8 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Dose Escalation of GS1-144 Tablets and the Effects of Food on the Pharmacokinetics of GS1-144 in a Chinese Population
- ClinicalTrials.gov ID
- NCT06385158
- Acronym / sponsor ID
- GenSci074-101
- Conditions
- Vasomotor System; Labile, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 6 Jan 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 25 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.
A Phase I clinical study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral dose escalation of GS1-144 tablets and the effects of food on the pharmacokinetics of GS1-144 in a Chinese population
Detailed description
The primary purpose of this study is to assess the safety and tolerability of single ascending doses of GS1-144 in healthy participants in Part 1 and assessing the food effect in Part 2,and to assess the safety and tolerability of multiple ascending doses of GS1-144 in healthy postmenopausal female participants in Part 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GS1-144 tablet | Experimental | Drug: GS1-144 tablet |
| placebo controlled study | Placebo comparator | Drug: GS1-144 tablet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Part 1and Part 2 only: healthy male and female subjects aged between 18 and 45 years inclusive; Part 3 only: healthy women aged between 40 and 65 years inclusive who have undergone natural menopause (natural menopause is defined as surgically sterile (hysterectomy, bilateral salpingectomy, tubal ligation or bilateral oophorectomy - verbal confirmation through medical history review acceptable) or postmenopausal (no menses for 12 months and confirmed by FSH level ≥40 mlU/mL);
- Body weight ≥ 50 kg (male), ≥ 45 kg (female) with a body mass index between 19.0 and 27.9 kg/m2 inclusive at screening
- From signing the ICF to 1 month (female subjects) /3 months (male subjects and their female partners) after the end of the study, no family planning and egg/sperm donation plans, and effective contraceptive methods (such as IUD, bilateral tubal/vasectomy, condom and safe period calculation, etc.) (applicable to Parts 1 and 2)' ' ● Volunteer to sign ICF and be able to understand and comply with the requirements of this study
Key exclusion criteria (24 listed)
- Any known allergy to the components or analogues of the investigational product, or those with an allergic constitution (such as allergy to two or more drugs or foods)；
- A history of currently suffering from any other cardiovascular, gastrointestinal, endocrine, hematological, hepatic, immunological, metabolic, urinary, pulmonary, neurological, dermatological, psychiatric, renal and/or other major diseases deemed clinically significant by the investigator;
- Known/confirmed history of malignancy；
- A history of epileptic seizure or increased risk of epileptic seizure, or subjects with a recent history (within six months prior to screening) of head trauma leading to loss of consciousness or concussion;
- A history of currently suffering from hypothalamic dysfunction;
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 |
|---|---|---|
| GS1-144 tabletGS1-144 tablet is an NK3R antagonist. | Drug | GS1-144 tablet, placebo controlled study |
Primary outcome
Part 1:Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 4
Number of participants with TEAEs and SAEs will be reported
Part 2: Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).
Time frame: Up to Day 9;
Number of participants with TEAEs and SAEs will be reported.
Part 3: Number of Participants With TEAEs and SAEs
Time frame: Up to Day 12
Number of female post-menopausal participants with TEAEs and SAEs will be reported.
16 secondary outcomes
Part1,Part2 and Part3 AUC0-t- Area Under the Drug Concentration-time Curve From Time 0 to the Last Sample Collection Time t for GS1-144
Time frame: Part 1 Day 1- pre-dose and up to 72 hour post-dose; Part 2 Days 1 and 6-pre-dose and up to 72 hour post-dose, Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose,
Part 1 , Part2 and Part 3: AUC0-infinity- Area Under the Drug Concentration-time Curve From 0 to Infinity for GS1-144
Time frame: Part 1 Day 1- pre-dose and up to 72 hour post-dose; Part 2 Days 1 and 6-pre-dose and up to 72 hour post-dose, Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose,
Part 1, Part2 and Part 3: Cmax- Maximum Observed Plasma Concentration for GS1-144
Time frame: Part 1 Day 1- pre-dose and up to 72 hour post-dose; Part 2 Days 1 and 6-pre-dose and up to 72 hour post-dose, Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose,
Part 1 Part2 and Part 3: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for GS1-144
Time frame: Part 1 Day 1- pre-dose and up to 24 hour post-dose; Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Part 1 Part2 and Part 3:: T1/2- Terminal Half-life for GS1-144
Time frame: Time Frame: Part 1 Day 1- pre-dose and up to 72 hour post-dose; Part 2 Days 1 and 6-pre-dose and up to 72 hour post-dose, Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Part 1 Part2 and Part 3: CL/F- Apparent Clearance for GS1-144
Time frame: Part 1 Day 1- pre-dose and up to 72 hour post-dose; Part 2 Days 1 and 6-pre-dose and up to 72 hour post-dose, Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Part 1 Part2 and Part 3: Vd/F- Apparent Volume of Distribution for GS1-144
Time frame: Part 1 Day 1- pre-dose and up to 72 hour post-dose; Part 2 Days 1 and 6-pre-dose and up to 72 hour post-dose, Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Cmax,ss- Observed Maximum Concentration at Steady State for GS1-144
Time frame: Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Part 3: Cmin,ss- Observed Minimum Concentration at Steady State for GS1-144
Time frame: Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Part 3: Tmax,ss- Time of Cmax at Steady State for GS1-144
Time frame: Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Part 3: Cavg,ss- Average Concentration at Steady State for GS1-144
Time frame: Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Part 3: AUC0-τ- Area Under the Drug Concentration-time Curve During the Dosing Interval at Steady State for GS1-144
Time frame: Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Part 3: CLss/F- CL for Bioavailability at Steady State for GS1-144
Time frame: Part 3 Days 1 and 7-pre-dose and up to 30 hour post-dose
Part 3: T1/2,ss- Terminal Half-life at Steady State for GS1-144
Time frame: Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Part 3: Accumulation Ratio for GS1-144
Time frame: Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose
Part 1: Baseline and placebo-adjusted changes in ∆∆QTc and other ECG parameters after oral administration of GF1-144 in healthy subjects
Time frame: Part 1 Day 1- pre-dose and up to 24 hour post-dose
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 8 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Vasomotor System; Labile
Recruiting
Hot Flashes and Neurovascular Function in Women
Hot Flashes, Menopause
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.
The record lists no contact. Use the official record to reach the sponsor.
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 GS1-144 tablet in people with Vasomotor System; Labile and Healthy Volunteer, run by Changchun GeneScience Pharmaceutical 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 4 inclusion and 24 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 8 May 2025. 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. Some participants in this study may receive a placebo. 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?
Part 1:Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Up to Day 4). The study lists 3 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 8 May 2025.