HealthyPhase 1NCT06003088

Relative Bioavailability and Pharmacodynamics of HSK7653 in Healthy Volunteers

A Phase 1 study testing HSK7653(5mg) and HSK7653(25mg) in people with Healthy, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate the relative bioavailability of HSK7653(5mg) given as formulation A versus formulation B. To investigate the relative bioavailability of HSK7653(25mg) given as formulation A versus formulation B. To investigate safety and pharmacodynamics of two doses of HSK7653 in healthy male subjects. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: HSK7653(5mg) and HSK7653(25mg)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: 1 siteChina
Study dates: 15 Jun 2022to 9 Sep 2022
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy male and female subjects, age ≥18 years old，with appropriate sex ratio；
A total body weight ≥40 kg for females and ≥50 kg for males；BMI of 19 to 26 kg/m^2(inclusive);
Subjects(and their partners) volunteered to use effective physical contraception, had no plans to have children or donate sperm/eggs from 14 days before the first dose to 6 months after the last dose;
Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

Who cannot join

Subjects who are allergic to two or more medicine, foods or pollens or have a history of allergy to the investigational product and the related compounds;
Have a history of severe unconscious hypoglycemia；
Clinical evidence or history of any of the following diseases:
Inflammatory bowel disease, gastritis, ulcers, bile duct stones, or gastrointestinal bleeding
Major gastrointestinal surgery (e.g., gastrectomy, gastrostomy, or enterectomy)
Pancreatic injury or pancreatitis

Show all 33Show fewer

Abnormal liver function tests (such as ALT, AST, serum bilirubin) , indicating liver disease or liver injury
Renal insufficiency
Urinary tract obstruction or difficulty in bladder emptying;
Evidence or history of chronic or serious diseases of the blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, mental disorders, metabolic disorders, or any other diseases that may affect the results of the study;
Serious trauma and surgery within 3 month prior to Screening;
Use of vaccines within 1 month prior to dosing;
Use of prescription within 1 month prior to dosing，or use of nonprescription drugs（i.e. vitamins and herbal medicines）within 14 days prior to dosing;
Participation in another trial with an investigational drug or instrument within 3 months prior to dosing and for the duration of the study;
History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor) within 6 months of Screening.
Use of alcohol during the trial,or have a positive result for alcohol breath test;
Smoking ≥5 cigarettes per day within 3 months prior to Screening;
Blood donation or loss of blood for≥ 400 mL or received blood transfusion or use of blood products within 3 months prior to Screening, or blood donation program for the duration of the study and for 1 month after the trial；
Drinking excessive amounts of tea, coffee, and/or caffeinated beverages daily (average more than 8 cups per day,1 cup =250 mL) within 3 months prior to Screening;
Use of grapefruit, pomelo, dragon fruit, mango and other fruits or related products that may affect metabolic enzymes within 7 days prior to dosing;
Use of products containing alcohol within 48 hours prior to dosing and for the duration of the study;
Smoking or using any tobacco product within 48 hours prior to dosing and for the duration of the study;
Strenuous activities within 48 hours prior to dosing;
Use of chocolate, food or beverages containing caffeine or xanthine within 48 hours prior to dosing;
History of drug abuse or drug dependence;
Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, or Treponema pallidum antibody (TPPA) has a positive result;
Any clinically significant physical examination, vital signs, electrocardiogram or clinical laboratory measurement abnormalities during screening, or Screening 12-lead ECG demonstrating QT interval >440 msec for males and >420 msec for females,or FPG< 3.9mmol/L or > 6.1mmol/L;
Pregnant or lactating women, or female subjects whose pregnancy test results are positive;
Lactose intolerant；
Subjects who have a history of fainting needles and blood, or who cannot tolerate venipuncture blood sampling;
Difficulty in swallowing tablets and capsules;
Special dietary requirements (e.g. vegetarians) or cannot follow a uniform diet during the trial;
Unable to cooperate to complete the study due to other reasons, or in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning

Other trials in China

About this study

Official title: A Randomized, Open-label, Two-Way Crossover Study to Evaluate Relative Bioavailability and Pharmacodynamics of Two Doses of HSK7653 in Healthy Volunteers

To investigate the relative bioavailability of HSK7653(5mg) given as formulation A versus formulation B.

To investigate the relative bioavailability of HSK7653(25mg) given as formulation A versus formulation B.

To investigate safety and pharmacodynamics of two doses of HSK7653 in healthy male subjects.

Conditions: Healthy
Being tested: HSK7653(5mg), HSK7653(25mg)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HSK7653(5mg)Drug
Also called HSK7653
Participants will receive a single oral dose of HSK7653(5mg) Formulation A Or a single oral dose of HSK7653(5mg) Formulation B on Day 1 Period 1. Depending on what Formulation was received on Day 1 Period 1, participants will receive either a single oral dose of HSK7653(5mg) Formulation A Or a single oral dose of HSK7653(5mg) Formulation B on Day 1 of Period 2. Each period lasts for 15 days.
HSK7653(25mg)Drug
Also called HSK7653
Participants will receive a single oral dose of HSK7653(25mg) Formulation A Or a single oral dose of HSK7653(25mg) Formulation B on Day 1 Period 1. Depending on what Formulation was received on Day 1 Period 1, participants will receive either a single oral dose of HSK7653(25mg) Formulation A Or a single oral dose of HSK7653(25mg) Formulation B on Day 1 of Period 2. Each period lasts for 15 days.

Study groups in NCT06003088
Study group	Role	What they receive
HSK7653(5mg) Sequence A(Formulation A + Formulation B)	Experimental	Participants will receive a single oral dose of treatment 1: Formulation A followed by a washout period of at least 36 days from first dose of HSK7653(5mg). After the washout period, participants will receive a single oral dose of Treatment 2: HSK7653(5mg) Formulation B. Receives: Drug: HSK7653(5mg)
HSK7653(5mg) Sequence B(Formulation B + Formulation A)	Experimental	Participants will receive a single oral dose of treatment 1: Formulation B followed by a washout period of at least 36 days from first dose of HSK7653(5mg). After the washout period, participants will receive a single oral dose of Treatment 2: HSK7653(5mg) Formulation A. Receives: Drug: HSK7653(5mg)
HSK7653(25mg) Sequence A(Formulation A + Formulation B)	Experimental	Participants will receive a single oral dose of treatment 1: Formulation A followed by a washout period of at least 36 days from first dose of HSK7653(25mg). After the washout period, participants will receive a single oral dose of Treatment 2: HSK7653(25mg) Formulation B. Receives: Drug: HSK7653(25mg)
HSK7653(25mg) Sequence B(Formulation B + Formulation A)	Experimental	Participants will receive a single oral dose of treatment 1: Formulation B followed by a washout period of at least 36 days from first dose of HSK7653(25mg). After the washout period, participants will receive a single oral dose of Treatment 2: HSK7653(25mg) Formulation A. Receives: Drug: HSK7653(25mg)

What is being measured

The primary outcome is the main question the study is designed to answer.

Relative bioavailability (F)
To Evaluate Relative Bioavailability (F) of Two Doses of HSK7653 in Healthy Volunteers.
Relative bioavailability of HSK7653(5mg) given as formulation A versus formulation B=AUC(0-t)(HSK7653(5mg) Formulation A)/AUC(0-t)(HSK7653(5mg) Formulation B).
Relative bioavailability of HSK7653(25mg) given as formulation A versus formulation B=AUC(0-t)(HSK7653(25mg) Formulation A)/AUC(0-t)(HSK7653(25mg) Formulation B).
Measured: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
AUC(0-t)
The pharmacokinetic parameters of HSK7653 in plasma
Measured: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
AUC(0-∞)
The pharmacokinetic parameters of HSK7653 in plasma
Measured: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
Cmax
The pharmacokinetic parameters of HSK7653 in plasma
Measured: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
Tmax
The pharmacokinetic parameters of HSK7653 in plasma
Measured: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
t1/2
The pharmacokinetic parameters of HSK7653 in plasma
Measured: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
λz
The pharmacokinetic parameters of HSK7653 in plasma
Measured: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
Vd/F
The pharmacokinetic parameters of HSK7653 in plasma
Measured: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
CL/F
The pharmacokinetic parameters of HSK7653 in plasma
Measured: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.

Secondary outcomes (5)

The Safety of HSK7653
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: From First dose until Follow up visit, assessed up to 3 months.
AUEC(0-last)
The pharmacodynamic parameters of HSK7653 in plasma
Measured: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
ECmax
The pharmacodynamic parameters of HSK7653 in plasma
Measured: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
ETmax
The pharmacodynamic parameters of HSK7653 in plasma
Measured: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
DPP-4(WAI-2W)
The pharmacodynamic parameters of HSK7653 in plasma
Measured: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jun 20229 Sep 2022

First posted21 Aug 2023
Study start15 Jun 2022
Primary completion12 Aug 2022
Study completion9 Sep 2022

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.
More trials run by Haisco Pharmaceutical Group 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: Crossover
Masking: None (open label)
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06003088
Sponsor's protocol ID: HSK7653-105
Status last verified: Aug 2023
First submitted: 11 Jan 2023
Last updated: 24 Aug 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Two-Way Crossover Study to Evaluate Relative Bioavailability and Pharmacodynamics of Two Doses of HSK7653 in Healthy Volunteers
ClinicalTrials.gov ID: NCT06003088
Acronym / sponsor ID: HSK7653-105
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
Study start: 15 Jun 2022 (actual)
Primary completion: 12 Aug 2022 (actual)
Study completion: 9 Sep 2022 (actual)
First posted: 21 Aug 2023 (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.

To investigate the relative bioavailability of HSK7653(5mg) given as formulation A versus formulation B.

To investigate the relative bioavailability of HSK7653(25mg) given as formulation A versus formulation B.

To investigate safety and pharmacodynamics of two doses of HSK7653 in healthy male subjects.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
HSK7653(5mg) Sequence A(Formulation A + Formulation B)	Experimental	Drug: HSK7653(5mg)Participants will receive a single oral dose of treatment 1: Formulation A followed by a washout period of at least 36 days from first dose of HSK7653(5mg). After the washout period, participants will receive a single oral dose of Treatment 2: HSK7653(5mg) Formulation B.
HSK7653(5mg) Sequence B(Formulation B + Formulation A)	Experimental	Drug: HSK7653(5mg)Participants will receive a single oral dose of treatment 1: Formulation B followed by a washout period of at least 36 days from first dose of HSK7653(5mg). After the washout period, participants will receive a single oral dose of Treatment 2: HSK7653(5mg) Formulation A.
HSK7653(25mg) Sequence A(Formulation A + Formulation B)	Experimental	Drug: HSK7653(25mg)Participants will receive a single oral dose of treatment 1: Formulation A followed by a washout period of at least 36 days from first dose of HSK7653(25mg). After the washout period, participants will receive a single oral dose of Treatment 2: HSK7653(25mg) Formulation B.
HSK7653(25mg) Sequence B(Formulation B + Formulation A)	Experimental	Drug: HSK7653(25mg)Participants will receive a single oral dose of treatment 1: Formulation B followed by a washout period of at least 36 days from first dose of HSK7653(25mg). After the washout period, participants will receive a single oral dose of Treatment 2: HSK7653(25mg) Formulation A.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Healthy male and female subjects, age ≥18 years old，with appropriate sex ratio；
A total body weight ≥40 kg for females and ≥50 kg for males；BMI of 19 to 26 kg/m^2(inclusive);
Subjects(and their partners) volunteered to use effective physical contraception, had no plans to have children or donate sperm/eggs from 14 days before the first dose to 6 months after the last dose;
Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

Key exclusion criteria (33 listed)

Subjects who are allergic to two or more medicine, foods or pollens or have a history of allergy to the investigational product and the related compounds;
Have a history of severe unconscious hypoglycemia；
Clinical evidence or history of any of the following diseases:
Evidence or history of chronic or serious diseases of the blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, mental disorders, metabolic disorders, or any other diseases that may affect the results of the study;
Serious trauma and surgery within 3 month prior to 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
HSK7653(5mg)Also: HSK7653Participants will receive a single oral dose of HSK7653(5mg) Formulation A Or a single oral dose of HSK7653(5mg) Formulation B on Day 1 Period 1. Depending on what Formulation was received on Day 1 Period 1, participants will receive either a single oral dose of HSK7653(5mg) Formulation A Or a single oral dose of HSK7653(5mg) Formulation B on Day 1 of Period 2. Each period lasts for 15 days.	Drug	HSK7653(5mg) Sequence A(Formulation A + Formulation B), HSK7653(5mg) Sequence B(Formulation B + Formulation A)
HSK7653(25mg)Also: HSK7653Participants will receive a single oral dose of HSK7653(25mg) Formulation A Or a single oral dose of HSK7653(25mg) Formulation B on Day 1 Period 1. Depending on what Formulation was received on Day 1 Period 1, participants will receive either a single oral dose of HSK7653(25mg) Formulation A Or a single oral dose of HSK7653(25mg) Formulation B on Day 1 of Period 2. Each period lasts for 15 days.	Drug	HSK7653(25mg) Sequence A(Formulation A + Formulation B), HSK7653(25mg) Sequence B(Formulation B + Formulation A)

Primary outcome

Relative bioavailability (F)
Time frame: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
To Evaluate Relative Bioavailability (F) of Two Doses of HSK7653 in Healthy Volunteers. Relative bioavailability of HSK7653(5mg) given as formulation A versus formulation B=AUC(0-t)(HSK7653(5mg) Formulation A)/AUC(0-t)(HSK7653(5mg) Formulation B). Relative bioavailability of HSK7653(25mg) given as formulation A versus formulation B=AUC(0-t)(HSK7653(25mg) Formulation A)/AUC(0-t)(HSK7653(25mg) Formulation B).
AUC(0-t)
Time frame: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
The pharmacokinetic parameters of HSK7653 in plasma
AUC(0-∞)
Time frame: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
The pharmacokinetic parameters of HSK7653 in plasma
Cmax
Time frame: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
The pharmacokinetic parameters of HSK7653 in plasma
Tmax
Time frame: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
The pharmacokinetic parameters of HSK7653 in plasma
t1/2
Time frame: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
The pharmacokinetic parameters of HSK7653 in plasma
λz
Time frame: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
The pharmacokinetic parameters of HSK7653 in plasma
Vd/F
Time frame: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
The pharmacokinetic parameters of HSK7653 in plasma
CL/F
Time frame: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
The pharmacokinetic parameters of HSK7653 in plasma

5 secondary outcomes

The Safety of HSK7653
Time frame: From First dose until Follow up visit, assessed up to 3 months.
AUEC(0-last)
Time frame: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
ECmax
Time frame: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
ETmax
Time frame: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.
DPP-4(WAI-2W)
Time frame: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours 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 24 Aug 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.

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 HSK7653(5mg) and HSK7653(25mg) in people with Healthy, run by Haisco Pharmaceutical Group 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 33 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 24 Aug 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. 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?

Relative bioavailability (F) (time frame: Pre-dose，0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168 and 336 hours post-dose.). 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?

On the ClinicalTrials.gov record for NCT06003088.

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 24 Aug 2023.