Resistant HypertensionPhase 1NCT06183671
JX09 SAD/MAD in Healthy Participants
A Phase 1 study testing JX09 in people with Resistant Hypertension, run by Ji Xing Pharmaceuticals Australia Pty Ltd at 1 site in Australia.
Trial summary
This is a phase 1, randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose study in healthy adult to test the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of JX09 when administered to healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- JX09
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Jan 2024to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18 to 55 years (inclusive)
- In good health as deemed by the Investigator through a medical evaluation, including medical history, physical examination, and laboratory tests
- Body mass index (BMI) between 18 and 32 kg/m2, with a minimum weight of 50 kg at Screening
Who cannot join
- Clinically significant oncologic, infectious, cardiovascular, pulmonary, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, immunologic, renal, psychiatric, or other condition that in the opinion of the Investigator or Medical Monitor would make is unsafe for the participant to join the study or fulfill its requirements.
- A clinical abnormality or abnormal laboratory parameter(s) in the opinion of the Investigator or Medical Monitor is likely to introduce additional risk or will affect data interpretation.
- Postural tachycardia or hypotension.
- Female of childbearing potential who is pregnant, lactating, or planning to become pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multi-Part, Single and Multiple Ascending Dose Study of JX09 in Healthy Adult Participants
This is a phase 1, randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose study in healthy adult to test the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of JX09 when administered to healthy adult subjects.
- Conditions
- Resistant Hypertension
- Being tested
- JX09 or placebo SAD, JX09 or placebo MAD, JX09
- Keywords
- Hypertension, Health Volunteer, Pharmacokinetic, Food effect
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JX09 or placebo SADDrug
For Part 1 SAD: JX09/placebo in capsule will be administered as a single oral dose. The nominal dose escalation scheme for the cohorts is 1, 3, 10, 30, 100, and 300 mg.
JX09 or placebo MADDrug
For Part 2 MAD: JX09/placebo in capsule will be administered for 11 days (once daily) The nominal dose escalation scheme for the cohorts is 2, 5, 10 and 20 mg.
JX09Drug
For Part 3 FE: JX09 in capsule will be administered as a two single oral doses separated by 15 days. The nominal dose is 10 mg.
| Study group | Role | What they receive |
|---|---|---|
| Ascending Single Doses | Experimental | 48 participants, 6 single ascending dose (SAD) cohorts (Cohorts 1 to 6). Within each cohort, 8 participants will be randomized in a 6:2 ratio, 6 participants receiving JX09 and 2 receiving placebo Receives: Drug: JX09 or placebo SAD |
| Ascending Multiple Doses | Experimental | 32 participants, 4 multiple ascending dose (MAD) cohorts (Cohorts 7 to 10). Within each cohort, 8 participants will be randomized in a 6:2 ratio, 6 participants receiving JX09 and 2 receiving placebo Receives: Drug: JX09 or placebo MAD |
| Food Effect | Experimental | 12 participants,1 single-dose food effect (FE) cohort (Cohort 11), open-label, two-sequence, two-period, crossover design, participants will be randomly assigned to 1 of the 2 crossover sequences Receives: Drug: JX09 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of adverse events and serious adverse events in health subjects.
The number of AEs and SAEs by using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Measured: For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
Clinically significant change from baseline in physical examinations in health subjects
The number of events that clinically significant change from baseline in physical examinations by measuring general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest, abdomen, skin, neurological extremities, etc.
Measured: For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
Clinically significant change from baseline in vital signs in health subjects
The number of events that clinically significant change from baseline in vital signs by measuring heart rate, blood pressure, temperature, and respiratory rate.
Measured: For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
Clinically significant change from baseline in electrocardiograms in health subjects
The number of events that clinically significant change from baseline in electrocardiograms by measuring heart rate, PR, QRS, QT and QTc interval.
Measured: For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
Clinically significant change from baseline in clinical laboratory tests in health subjects
The number of events that clinically significant change from baseline in clinical laboratory tests by measuring clinical chemistry panel, complete blood count and coagulation.
Measured: For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
Secondary outcomes (23)
Plasma pharmacokinetic parameters after a single ascending dose in health subjects
Area under the Concentration time Curve from Time 0 to the Last Measurable Concentration (AUC0-t) by measuring blood plasma
Measured: From Day 1 to Day 11
Plasma pharmacokinetic parameters after a single ascending dose in health subjects
Area under the Concentration-time Curve from Time 0 to 24 hour (AUC0-24) by measuring blood plasma
Measured: From Day 1 to Day 11
Plasma pharmacokinetic parameters after a single ascending dose in health subjects
Area under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) by measuring blood plasma
Measured: From Day 1 to Day 11
Plasma pharmacokinetic parameters after a single ascending dose in health subjects
Peak plasma concentration (CMAX) by measuring blood plasma
Measured: From Day 1 to Day 11
Plasma pharmacokinetic parameters after a single ascending dose in health subjects
Time of maximum concentration (TMAX) by measuring blood plasma
Measured: From Day 1 to Day 11
Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
Peak plasma concentration (CMAX) by measuring blood plasma
Measured: On day 1 and day 11
Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
Time of maximum concentration (TMAX) by measuring blood plasma
Measured: On day 1 and day 11
Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
Area under the Concentration time Curve from Time 0 to the Last Measurable Concentration (AUC0-t) by measuring blood plasma
Measured: On day 1 and day 11
Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
Area under the Concentration-time Curve from Time 0 to 24 hour (AUC0-24) by measuring blood plasma
Measured: On day 1 and day 11
Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
Concentration at end of dosing interval by measuring blood plasma
Measured: From day 2 to day 11
Plasma pharmacokinetic parameters in health subjects under fed and fasted conditions
Area under the Concentration time Curve from Time 0 to the Last Measurable Concentration (AUC0-t) by measuring blood plasma
Measured: From day 1 to day 5 and on day 11, From day 16 to day 20 and day 26
Plasma pharmacokinetic parameters in health subjects under fed and fasted conditions
Area under the Concentration-time Curve from Time 0 to 24 hour (AUC0-24) by measuring blood plasma
Measured: From day 1 to day 5 and on day 11, From day 16 to day 20 and day 26
Plasma pharmacokinetic parameters in health subjects under fed and fasted conditions
Area under the Concentration-time Curve from Time 0 to Infinity (AUC0-inf) by measuring blood plasma
Measured: From day 1 to day 5 and on day 11, From day 16 to day 20 and day 26
Urine pharmacokinetic parameters after multiple ascending dose in health subjects
Cumulative amount of drug excreted by measuring urine
Measured: on day 1 and day 11
Urine pharmacokinetic parameters after multiple ascending dose in health subjects
Fraction of the dose excreted renally by measuring urine
Measured: on day 1 and day 11
Urine pharmacokinetic parameters after multiple ascending dose in health subjects
Renal clearance by measuring urine
Measured: on day 1 and day 11
Plasma pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Change from baseline of aldosterone by measuring blood plasma
Measured: From Day -1 to Day 5 and Day 11 for SAD cohort and from Day -2 to Day 1 and from Day 7 to Day 15 and Day 21 for MAD cohort
Plasma pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Change from baseline of cortisol by measuring blood plasma
Measured: From Day -1 to Day 5 and Day 11 for SAD cohort and from Day -2 to Day 1 and from Day 7 to Day 15 and Day 21 for MAD cohort
Plasma pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Change from baseline of corticosterone by measuring blood plasma
Measured: From Day -1 to Day 5 and Day 11 for SAD cohort and from Day -2 to Day 1 and from Day 7 to Day 15 and Day 21 for MAD cohort
Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Change from baseline of sodium by measuring 24-hour urine level
Measured: On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Change from baseline of potassium by measuring 24-hour urine level
Measured: On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Change from baseline of aldosterone by measuring 24-hour urine level
Measured: On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Change from baseline of cortisol by measuring 24-hour urine level
Measured: On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start18 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistant HypertensionStudies 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
- Model description
- Double-Blind, Placebo-Controlled, Multi-Part
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ji Xing Pharmaceuticals Australia Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Responsible party
- Sponsor
- Investigators
- Sam Francis, MD, Principal investigator, Nucleus Network Pty Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183671
- Sponsor's protocol ID
- JX09002
- Status last verified
- Oct 2026
- First submitted
- 20 Nov 2023
- Last updated
- 29 Oct 2026
- 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 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multi-Part, Single and Multiple Ascending Dose Study of JX09 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06183671
- Acronym / sponsor ID
- JX09002
- Conditions
- Resistant Hypertension
- Keywords
- Hypertension, Health Volunteer, Pharmacokinetic, Food effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Ji Xing Pharmaceuticals Australia Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Novotech (Australia) Pty Limited
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 27 Dec 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.
This is a phase 1, randomized, double-blind, placebo-controlled, multi-part, single and multiple ascending dose study in healthy adult to test the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effect of JX09 when administered to healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Double-Blind, Placebo-Controlled, Multi-Part
| Arm | Type | Receives |
|---|---|---|
| Ascending Single Doses | Experimental | Drug: JX09 or placebo SAD48 participants, 6 single ascending dose (SAD) cohorts (Cohorts 1 to 6). Within each cohort, 8 participants will be randomized in a 6:2 ratio, 6 participants receiving JX09 and 2 receiving placebo |
| Ascending Multiple Doses | Experimental | Drug: JX09 or placebo MAD32 participants, 4 multiple ascending dose (MAD) cohorts (Cohorts 7 to 10). Within each cohort, 8 participants will be randomized in a 6:2 ratio, 6 participants receiving JX09 and 2 receiving placebo |
| Food Effect | Experimental | Drug: JX0912 participants,1 single-dose food effect (FE) cohort (Cohort 11), open-label, two-sequence, two-period, crossover design, participants will be randomly assigned to 1 of the 2 crossover sequences |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male or female aged 18 to 55 years (inclusive)
- In good health as deemed by the Investigator through a medical evaluation, including medical history, physical examination, and laboratory tests
- Body mass index (BMI) between 18 and 32 kg/m2, with a minimum weight of 50 kg at Screening
Key exclusion criteria (4 listed)
- Clinically significant oncologic, infectious, cardiovascular, pulmonary, hepatic, gastrointestinal, hematologic, metabolic, endocrine, neurologic, immunologic, renal, psychiatric, or other condition that in the opinion of the Investigator or Medical Monitor would make is unsafe for the participant to join the study or fulfill its requirements.
- A clinical abnormality or abnormal laboratory parameter(s) in the opinion of the Investigator or Medical Monitor is likely to introduce additional risk or will affect data interpretation.
- Postural tachycardia or hypotension.
- Female of childbearing potential who is pregnant, lactating, or planning to become pregnant.
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 |
|---|---|---|
| JX09 or placebo SADFor Part 1 SAD: JX09/placebo in capsule will be administered as a single oral dose. The nominal dose escalation scheme for the cohorts is 1, 3, 10, 30, 100, and 300 mg. | Drug | Ascending Single Doses |
| JX09 or placebo MADFor Part 2 MAD: JX09/placebo in capsule will be administered for 11 days (once daily) The nominal dose escalation scheme for the cohorts is 2, 5, 10 and 20 mg. | Drug | Ascending Multiple Doses |
| JX09For Part 3 FE: JX09 in capsule will be administered as a two single oral doses separated by 15 days. The nominal dose is 10 mg. | Drug | Food Effect |
Primary outcome
The incidence of adverse events and serious adverse events in health subjects.
Time frame: For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
The number of AEs and SAEs by using Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Clinically significant change from baseline in physical examinations in health subjects
Time frame: For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
The number of events that clinically significant change from baseline in physical examinations by measuring general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest, abdomen, skin, neurological extremities, etc.
Clinically significant change from baseline in vital signs in health subjects
Time frame: For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
The number of events that clinically significant change from baseline in vital signs by measuring heart rate, blood pressure, temperature, and respiratory rate.
Clinically significant change from baseline in electrocardiograms in health subjects
Time frame: For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
The number of events that clinically significant change from baseline in electrocardiograms by measuring heart rate, PR, QRS, QT and QTc interval.
Clinically significant change from baseline in clinical laboratory tests in health subjects
Time frame: For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26
The number of events that clinically significant change from baseline in clinical laboratory tests by measuring clinical chemistry panel, complete blood count and coagulation.
23 secondary outcomes
Plasma pharmacokinetic parameters after a single ascending dose in health subjects
Time frame: From Day 1 to Day 11
Plasma pharmacokinetic parameters after a single ascending dose in health subjects
Time frame: From Day 1 to Day 11
Plasma pharmacokinetic parameters after a single ascending dose in health subjects
Time frame: From Day 1 to Day 11
Plasma pharmacokinetic parameters after a single ascending dose in health subjects
Time frame: From Day 1 to Day 11
Plasma pharmacokinetic parameters after a single ascending dose in health subjects
Time frame: From Day 1 to Day 11
Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
Time frame: On day 1 and day 11
Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
Time frame: On day 1 and day 11
Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
Time frame: On day 1 and day 11
Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
Time frame: On day 1 and day 11
Plasma pharmacokinetic parameters after multiple ascending dose in health subjects
Time frame: From day 2 to day 11
Plasma pharmacokinetic parameters in health subjects under fed and fasted conditions
Time frame: From day 1 to day 5 and on day 11, From day 16 to day 20 and day 26
Plasma pharmacokinetic parameters in health subjects under fed and fasted conditions
Time frame: From day 1 to day 5 and on day 11, From day 16 to day 20 and day 26
Plasma pharmacokinetic parameters in health subjects under fed and fasted conditions
Time frame: From day 1 to day 5 and on day 11, From day 16 to day 20 and day 26
Urine pharmacokinetic parameters after multiple ascending dose in health subjects
Time frame: on day 1 and day 11
Urine pharmacokinetic parameters after multiple ascending dose in health subjects
Time frame: on day 1 and day 11
Urine pharmacokinetic parameters after multiple ascending dose in health subjects
Time frame: on day 1 and day 11
Plasma pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Time frame: From Day -1 to Day 5 and Day 11 for SAD cohort and from Day -2 to Day 1 and from Day 7 to Day 15 and Day 21 for MAD cohort
Plasma pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Time frame: From Day -1 to Day 5 and Day 11 for SAD cohort and from Day -2 to Day 1 and from Day 7 to Day 15 and Day 21 for MAD cohort
Plasma pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Time frame: From Day -1 to Day 5 and Day 11 for SAD cohort and from Day -2 to Day 1 and from Day 7 to Day 15 and Day 21 for MAD cohort
Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Time frame: On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Time frame: On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Time frame: On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
Urine pharmacodynamic parameters after a single ascending dose or multiple ascending dose in health subjects
Time frame: On Day 1 for SAD cohort and on Day -1 and 11 for MAD cohort
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 29 Oct 2026.
Related trials for Resistant Hypertension
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Not yet recruitingPhase 2
A Study Evaluating the Efficacy and Safety of SYH2072 Tablets In Hypertensive Patients
Uncontrolled Hypertension, Resistant Hypertension
Not yet recruitingObservational study
Common Carotid Artery-Renal Artery-Femoral Artery Survey for Hypertension
Hypertension, Hypertension (HTN)
Active, not recruiting
Electronic Alert to Improve Testing For Primary Aldosteronism in Patients With Hypertension
Primary Aldosteronism, Resistant Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
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.
Sam Francis, MD principal investigator
Nucleus Network Pty Ltd.
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 JX09 in people with Resistant Hypertension, run by Ji Xing Pharmaceuticals Australia Pty Ltd at 1 site in Australia.
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 3 inclusion and 4 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 29 Oct 2026. 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 Australia. 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?
The incidence of adverse events and serious adverse events in health subjects. (time frame: For SAD cohort,11 days, from Day 1 to Day 11; for MAD cohort,21 days, from Day 1 to Day 21; for food effect cohort,26 days, from Day 1 to Day 26). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.