SchizophreniaPhase 1NCT05480592
A Study of HS-10380 in Chinese Participants
A Phase 1 study testing HS-10380 in people with Schizophrenia, run by Jiangsu Hansoh Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The primary objective of this study is to assess the safety and tolerability of single and multiple oral administered doses of HS-10380 in Chinese healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- HS-10380
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 30 Jul 2023
- 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
- Healthy subject aged from 18 to 45 years;
- Subject has a Body Mass Index (BMI) between 18.5 and 26.0 kg/m2 at screening and the weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg;
- Voluntary subject who signs the informed consent form after understanding the purpose, content, process and possible risks of the trial;
- Subject is able to communicate well with the investigator and comply with the lifestyle constraints specified in the protocol, and cooperate to complete the trial procedures.
Who cannot join
- Subject has history or presence of disease or dysfunction affecting the clinical trial, including but not limited to neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, musculoskeletal system, metabolic endocrine system, skin disease, blood system disease, immune system and tumor, etc.;
- Subject has any surgical condition or condition that may significantly affect the absorption, distribution, metabolism, and excretion of the drug, or any surgical condition or condition that may pose a hazard to the subjects participating in the trial, such as gastrointestinal surgery (gastrectomy, Gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, peptic ulcer, history of gastrointestinal bleeding, etc.;
- Subject has a history of significant drug allergies or known allergies to the components of the test drug;
- Subject has history or presence of psychiatric disorders and cerebral dysfunction, or subjects at risk of suicide according to the Columbia Suicide Severity Rating Scale (C-SSRS) or at risk of suicide according to the investigator's clinical judgment, or has a history of self-harm;
- Subject has a history of drug abuse within 1 year prior to screening, or has a positive urine drug result screen at screening;
- Subject has history of alcohol abuse or a single consumption of more than 14 units of alcohol (1 unit = 285 mL of beer, 25 mL of spirits, 150 mL of wine) in the nearly one year prior to screening or a positive breath test for alcohol at screening;
Show all 20Show fewer
- Subject has smoked ≥5 cigarettes per day or consumed an average of ≥5 (200mL/cup) cups of coffee or tea per day in the 3 months before screening, or could not stop users during the study;
- Subject has special requirements for food or is unwilling to accept a uniform diet or has difficulty swallowing;
- Pregnant or breastfeeding women, or those who refuse to use effective contraception (eg, abstinence, IUD) throughout the study period and 6 months after the end of the study, or those who have a sperm or egg donation plan;
- Subject has clinically significant abnormal comprehensive physical examination, vital signs, laboratory tests, and 12-lead electrocardiograms, which are judged by the investigator (eg: QTcF>450ms for men and >470ms for women, Friericia correction);
- Subject with resting pulse rate <55 bpm or >100 bpm; systolic blood pressure <90mmHg or >140mmHg; diastolic blood pressure <60mmHg or >90mmHg at screening;
- Subject has detectable hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibody at screening;
- Subject with alanine aminotransferase (ALT), creatinine (Cr), blood urea nitrogen (BUN) exceeding the upper limit of normal or serum prolactin greater than 2 times the upper limit of normal at the time of screening;
- Subject has donated blood or lost blood ≥ 400ml within 3 months before screening, or donated blood or lost blood ≥ 200ml within one month, or has a history of using blood products;
- Subject with a history of surgery within 3 months prior to screening, or who have not recovered from surgery, or who have anticipated surgery plans during the trial;
- Subject has taken any medication within 2 weeks (or 5 half-lives, whichever is longer) prior to screening or takes any medication throughout study, including prescription and over-the-counter medications, Chinese herbal medicines, and any drugs that inhibit or induce liver drug metabolizing enzymes (such as inducers and/or inhibitors of CYP3A4, CYP2D6 and CYP3A5);
- Subject has participated in any clinical trial or took any clinical trial drugs within 3 months before screening;
- Subject has dieted or received dietary therapy, or had significant changes in dietary habits within 30 days prior to screening;
- Subject has a history of vaccination within 30 days prior to screening, or has a vaccination schedule throughout the study;
- Subject with poor compliance or other problems which the investigator considers unsuitable for subject to participate.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Yan Li, MD, 021-34773128, liyan7721@163.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HS-10380 in Chinese Healthy Adult Subjects
The primary objective of this study is to assess the safety and tolerability of single and multiple oral administered doses of HS-10380 in Chinese healthy subjects.
Read the detailed description
This is a phase I, randomized, double-blinded, placebo-controlled, both single ascending doses (SAD) study and multiple ascending dose (MAD) clinical trial to assess the safety, tolerability, and pharmacokinetics of HS-10380 in Chinese healthy subjects.
There will be four phases in SAD and MAD study: a 2-week screening phase, a 1-day baseline phase, a double-blind treatment phase, and a 1-week post-treatment (follow-up) phase.
- Conditions
- Schizophrenia
- Being tested
- HS-10380, Placebo
- Keywords
- Schizophrenia, HS-10380
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10380Drug
Administered orally as a tablet
PlaceboDrug
Administered orally as a tablet
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose (SAD) | Experimental | Subjects in cohorts 1-6 will receive oral administration of single dose of HS-10380 tablets or matching placebo. Receives: Drug: HS-10380; Drug: Placebo |
| Multiple Ascending Dose (MAD) | Placebo comparator | Subjects in cohorts 7 will receive oral administration of 7 dose of HS-10380 tablets or matching placebo. Receives: Drug: HS-10380; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Experiencing Adverse Events (AEs)
AE include adverse events (AEs) and serious adverse events (SAEs)
Measured: Baseline to end of follow-up (a maximum of 20 days)
Changes from baseline in laboratory tests
Laboratory tests include blood routine, urine routine, blood biochemistry, coagulation function, thyroid function and serum prolactin;
Measured: Baseline to end of follow-up (a maximum of 20 days)
Changes from baseline in vital signs
Vital signs include respiration, pulse, blood pressure, body temperature and SpO2
Measured: Baseline to end of follow-up (a maximum of 20 days)
Change from baseline in Electrocardiogram (ECG)
ECG parameters including heart rate, PR interval, RR interval and QTcF, etc.
Measured: Baseline to end of follow-up (a maximum of 20 days)
Change from baseline in weight (kg)
Measured: Baseline to end of follow-up (a maximum of 20 days)
Change from baseline in physical examination
Including general condition, heart, chest and abdomen, skin and mucous membranes, lymph node examination, etc.
Measured: Baseline to end of follow-up (a maximum of 20 days)
Change from baseline in Simpson-Angus Scale (SAS) score
The SAS is a 10-item testing instrument used to evaluate drug-related extrapyramidal syndromes. The following items are included in the SAS: gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella reflex, tremor, and salivation. Total score ranges from 0 to 40 with a higher score indicating increased severity.
Measured: Baseline to end of follow-up (a maximum of 20 days)
Change from baseline in Abnormal Involuntary Movement Scale (AIMS) score
AIMS is a rating scale measuring involuntary movements known as tardive dyskinesia, that sometimes develop as a side effect of long-term treatment with antipsychotic medications. The AIMS score was calculated as the sum of questions 1 through 7 of the AIMS instrument, which includes assessments of involuntary movements in the face, lips, jaw, tongue, upper and lower extremities, and neck/shoulders/hips. Each item is rated on a five-point scale of severity from 0-4 with 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Total scores range from 0 to 28.
Measured: Baseline to end of follow-up (a maximum of 20 days)
Change from baseline in Barnes Akathisia Rating Scale (BARS) score
BAS is a rating scale that is administered by physicians to assess the severity of drug-induced akathisia, which is a movement disorder characterized by a feeling of inner restlessness and a compelling need to be in constant motion, as well as by actions such as rocking while standing or sitting, lifting the feet as if marching on the spot, and crossing and uncrossing the legs while sitting. The following subcategories are scored: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness and are rated on a 4-point scale from 0-3. In addition, the global clinical assessment of akathisia uses a 6-point scale ranging from 0-5. Total score ranges from 0 to 14 with a higher score indicating increased severity.
Measured: Baseline to end of follow-up (a maximum of 20 days)
Secondary outcomes (17)
Maximum plasma concentration (Cmax) of single-dose HS-10380 administration
Measured: Up to 120 hours post-dose
Time of the Maximum Concentration (Tmax) of single-dose HS-10380 administration
Measured: Up to 120 hours post-dose
Terminal rate constant (λz) of single-dose HS-10380 administration
Measured: Up to 120 hours post-dose
Elimination half-life (t1/2) of single-dose HS-10380 administration
Measured: Up to 120 hours post-dose
Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC0-t) of single-dose HS-10380 administration
Measured: Up to 120 hours post-dose
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC0-∞) of single-dose HS-10380 administration
Measured: Up to 120 hours post-dose
Apparent clearance (CL/F) of single-dose HS-10380 administration
Measured: Up to 120 hours post-dose
Apparent volume of distribution (Vd/F) of single-dose HS-10380 administration
Measured: Up to 120 hours post-dose
Mean retention time (MRT) of single-dose HS-10380 administration
Measured: Up to 120 hours post-dose
Maximum plasma concentration (Cmax) of first HS-10380 administration
Measured: Up to 12 days
Time of the Maximum Concentration (Tmax) of first HS-10380 administration
Measured: Up to 12 days
Area under the plasma concentration-time curve from time zero to 24 hours (AUC0-24) first HS-10380 administration
Measured: Up to 24 hours
Maximum concentration at steady state (Css, max) of multiple-dose HS-10380 administration
Measured: Up to 12 days
Time of the maximum concentration at steady state (Tss, max) of multiple-dose HS-10380 administration
Measured: Up to 12 days
Minimum concentration at steady state (Css, min) of multiple-dose HS-10380 administration
Measured: Up to 12 days
Area under the concentration-time curve at steady state (AUCss) of multiple-dose HS-10380 administration
Measured: Up to 12 days
Accumulation ratio (RAC) after multiple doses
Measured: Up to 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Aug 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480592
- Sponsor's protocol ID
- HS-10380-101
- Status last verified
- Feb 2023
- First submitted
- 5 Jul 2022
- Last updated
- 9 Mar 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 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HS-10380 in Chinese Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05480592
- Acronym / sponsor ID
- HS-10380-101
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, HS-10380
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 29 Jul 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.
The primary objective of this study is to assess the safety and tolerability of single and multiple oral administered doses of HS-10380 in Chinese healthy subjects.
Detailed description
This is a phase I, randomized, double-blinded, placebo-controlled, both single ascending doses (SAD) study and multiple ascending dose (MAD) clinical trial to assess the safety, tolerability, and pharmacokinetics of HS-10380 in Chinese healthy subjects.
There will be four phases in SAD and MAD study: a 2-week screening phase, a 1-day baseline phase, a double-blind treatment phase, and a 1-week post-treatment (follow-up) phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (SAD) | Experimental | Drug: HS-10380, Drug: PlaceboSubjects in cohorts 1-6 will receive oral administration of single dose of HS-10380 tablets or matching placebo. |
| Multiple Ascending Dose (MAD) | Placebo comparator | Drug: HS-10380, Drug: PlaceboSubjects in cohorts 7 will receive oral administration of 7 dose of HS-10380 tablets or matching placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subject aged from 18 to 45 years;
- Subject has a Body Mass Index (BMI) between 18.5 and 26.0 kg/m2 at screening and the weight of male subjects is not less than 50 kg, and the weight of female subjects is not less than 45 kg;
- Voluntary subject who signs the informed consent form after understanding the purpose, content, process and possible risks of the trial;
- Subject is able to communicate well with the investigator and comply with the lifestyle constraints specified in the protocol, and cooperate to complete the trial procedures.
Key exclusion criteria (20 listed)
- Subject has history or presence of disease or dysfunction affecting the clinical trial, including but not limited to neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, musculoskeletal system, metabolic endocrine system, skin disease, blood system disease, immune system and tumor, etc.;
- Subject has any surgical condition or condition that may significantly affect the absorption, distribution, metabolism, and excretion of the drug, or any surgical condition or condition that may pose a hazard to the subjects participating in the trial, such as gastrointestinal surgery (gastrectomy, Gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, peptic ulcer, history of gastrointestinal bleeding, etc.;
- Subject has a history of significant drug allergies or known allergies to the components of the test drug;
- Subject has history or presence of psychiatric disorders and cerebral dysfunction, or subjects at risk of suicide according to the Columbia Suicide Severity Rating Scale (C-SSRS) or at risk of suicide according to the investigator's clinical judgment, or has a history of self-harm;
- Subject has a history of drug abuse within 1 year prior to screening, or has a positive urine drug result screen at screening;
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 |
|---|---|---|
| HS-10380Administered orally as a tablet | Drug | Multiple Ascending Dose (MAD), Single Ascending Dose (SAD) |
| PlaceboAdministered orally as a tablet | Drug | Multiple Ascending Dose (MAD), Single Ascending Dose (SAD) |
Primary outcome
Number of Subjects Experiencing Adverse Events (AEs)
Time frame: Baseline to end of follow-up (a maximum of 20 days)
AE include adverse events (AEs) and serious adverse events (SAEs)
Changes from baseline in laboratory tests
Time frame: Baseline to end of follow-up (a maximum of 20 days)
Laboratory tests include blood routine, urine routine, blood biochemistry, coagulation function, thyroid function and serum prolactin;
Changes from baseline in vital signs
Time frame: Baseline to end of follow-up (a maximum of 20 days)
Vital signs include respiration, pulse, blood pressure, body temperature and SpO2
Change from baseline in Electrocardiogram (ECG)
Time frame: Baseline to end of follow-up (a maximum of 20 days)
ECG parameters including heart rate, PR interval, RR interval and QTcF, etc.
Change from baseline in weight (kg)
Time frame: Baseline to end of follow-up (a maximum of 20 days)
Change from baseline in physical examination
Time frame: Baseline to end of follow-up (a maximum of 20 days)
Including general condition, heart, chest and abdomen, skin and mucous membranes, lymph node examination, etc.
Change from baseline in Simpson-Angus Scale (SAS) score
Time frame: Baseline to end of follow-up (a maximum of 20 days)
The SAS is a 10-item testing instrument used to evaluate drug-related extrapyramidal syndromes. The following items are included in the SAS: gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head dropping, glabella reflex, tremor, and salivation. Total score ranges from 0 to 40 with a higher score indicating increased severity.
Change from baseline in Abnormal Involuntary Movement Scale (AIMS) score
Time frame: Baseline to end of follow-up (a maximum of 20 days)
AIMS is a rating scale measuring involuntary movements known as tardive dyskinesia, that sometimes develop as a side effect of long-term treatment with antipsychotic medications. The AIMS score was calculated as the sum of questions 1 through 7 of the AIMS instrument, which includes assessments of involuntary movements in the face, lips, jaw, tongue, upper and lower extremities, and neck/shoulders/hips. Each item is rated on a five-point scale of severity from 0-4 with 0 (none), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe). Total scores range from 0 to 28.
Change from baseline in Barnes Akathisia Rating Scale (BARS) score
Time frame: Baseline to end of follow-up (a maximum of 20 days)
BAS is a rating scale that is administered by physicians to assess the severity of drug-induced akathisia, which is a movement disorder characterized by a feeling of inner restlessness and a compelling need to be in constant motion, as well as by actions such as rocking while standing or sitting, lifting the feet as if marching on the spot, and crossing and uncrossing the legs while sitting. The following subcategories are scored: objective akathisia, subjective awareness of restlessness and subjective distress related to restlessness and are rated on a 4-point scale from 0-3. In addition, the global clinical assessment of akathisia uses a 6-point scale ranging from 0-5. Total score ranges from 0 to 14 with a higher score indicating increased severity.
17 secondary outcomes
Maximum plasma concentration (Cmax) of single-dose HS-10380 administration
Time frame: Up to 120 hours post-dose
Time of the Maximum Concentration (Tmax) of single-dose HS-10380 administration
Time frame: Up to 120 hours post-dose
Terminal rate constant (λz) of single-dose HS-10380 administration
Time frame: Up to 120 hours post-dose
Elimination half-life (t1/2) of single-dose HS-10380 administration
Time frame: Up to 120 hours post-dose
Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC0-t) of single-dose HS-10380 administration
Time frame: Up to 120 hours post-dose
Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC0-∞) of single-dose HS-10380 administration
Time frame: Up to 120 hours post-dose
Apparent clearance (CL/F) of single-dose HS-10380 administration
Time frame: Up to 120 hours post-dose
Apparent volume of distribution (Vd/F) of single-dose HS-10380 administration
Time frame: Up to 120 hours post-dose
Mean retention time (MRT) of single-dose HS-10380 administration
Time frame: Up to 120 hours post-dose
Maximum plasma concentration (Cmax) of first HS-10380 administration
Time frame: Up to 12 days
Time of the Maximum Concentration (Tmax) of first HS-10380 administration
Time frame: Up to 12 days
Area under the plasma concentration-time curve from time zero to 24 hours (AUC0-24) first HS-10380 administration
Time frame: Up to 24 hours
Maximum concentration at steady state (Css, max) of multiple-dose HS-10380 administration
Time frame: Up to 12 days
Time of the maximum concentration at steady state (Tss, max) of multiple-dose HS-10380 administration
Time frame: Up to 12 days
Minimum concentration at steady state (Css, min) of multiple-dose HS-10380 administration
Time frame: Up to 12 days
Area under the concentration-time curve at steady state (AUCss) of multiple-dose HS-10380 administration
Time frame: Up to 12 days
Accumulation ratio (RAC) after multiple doses
Time frame: Up to 12 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 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.
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 HS-10380 in people with Schizophrenia, run by Jiangsu Hansoh 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 20 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 9 Mar 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huafang Li, MD (021-34773128, lhlh_5@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Experiencing Adverse Events (AEs) (time frame: Baseline to end of follow-up (a maximum of 20 days)). 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 9 Mar 2023.