OsteoarthritisPhase 1NCT05496205
A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers
A Phase 1 study testing iN1011-N17 in people with Osteoarthritis and Pain, run by iN Therapeutics Co., Ltd. at 1 site in Australia.
Trial summary
A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of iN1011-N17 after Oral Administration in Healthy Volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Pain, Post Herpetic Neuralgia
- What is being tested?
- iN1011-N17
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Sep 2020to 8 Oct 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female adults aged 18 to 55 years (inclusive at the time of written informed consent).
- Body mass index (BMI = body weight (kg)/[height (m)]2) between 18 kg/m2 and 32 kg/m2 (inclusive) at the time of Screening, and a minimum weight of 50 kg.
- Clinical laboratory values within normal range as specified by the testing laboratory at Screening and Day -1, unless deemed not clinically significant by the Investigator.
- Clinically acceptable blood pressure (BP), pulse, respiratory rate (RR), and body temperature (SBP between 90 and 140 mmHg; DBP between 40 and 90 mmHg; pulse between 40 and 100 bpm; RR between 10 and 22 breaths/min; body temperature between 35.5°C and 37.5°C) at Screening and Day -1. Measurements are to be recorded after a minimum of 5 minutes of resting in sitting or supine position.
- Female subjects must be of non-child-bearing potential, defined as:
- Surgically sterile (i.e., had a bilateral tubal ligation, hysterectomy, salpingectomy, or bilateral oophorectomy at least 6 months before the first dose of investigational product [IP]) or;
Show all 25Show fewer
- Postmenopausal for at least 1 year before the first dose of IP, and if they have follicle-stimulating hormone (FSH) levels in the postmenopausal range for the investigational site/institution.
- OR
- Female subjects of child-bearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day -1, and must not be breastfeeding, lactating or planning pregnancy during the study period.
- Female subjects must agree to use adequate contraception from Screening until 30 days after the last dose of IP.
- Adequate contraception is defined as a condom for the male partner combined with either:
- Non-hormonal intrauterine device (IUD)
- Vasectomized partner with documented azoospermia 90 days after procedure, if that partner is the sole sexual partner
- Male subjects who are sexually active must use a condom combined with use of a highly-effective method of contraception for the female partner. Acceptable highly-effective forms of contraception for partners of male subjects are as follows:
- Hormonal methods of contraception including oral contraceptives containing estrogen and progesterone, a vaginal ring, injectable and implantable hormonal contraceptives, intrauterine hormone-releasing system (e.g. Mirena) and progesterone-only hormonal contraception associated with inhibition of ovulation.
- Non-hormonal intrauterine device (IUD).
- Bilateral tubal occlusion.
- Surgically sterile.
- Post-menopausal status. Male subjects must continue to use adequate contraception, as well as refrain from donating sperm for 90 days after the last dose of IP.
- Complete abstinence is an acceptable form of contraception where it is the usual and preferred lifestyle.
- Subjects who are exclusively in same-sex relationships are not required to use contraception, however, males should refrain from donating sperm for 90 days after the last dose of IP and females should refrain from donating ova or undergoing fertility treatment for 30 days following the last dose of IP.
- Cognitively capable of understanding the provided information and able to fully comply with protocol requirements.
- Written informed consent prior to the commencement of any study procedures.
- Willing and able to perform the necessary visits to the investigational site/institution.
- In good general health at the Investigator's discretion, with no significant medical history, and with no clinically significant abnormalities on physical examination at Screening and before the first dose of IP.
Who cannot join
- Presence or history of hepatic, renal, neurological, pulmonary, endocrine, hematologic, cardiovascular or genitourinary disease that, in the opinion of the Investigator, may affect the evaluation of the investigational product or place the participant at undue risk.
- Presence of any underlying physical or psychiatric condition that, in the opinion of the Investigator, would undermine subject compliance to protocol requirements.
- Presence or history of gastrointestinal disease (e.g., peptic ulcer, gastritis, gastric cramp, gastroesophageal reflex disease, Crohn's disease) or history of gastrointestinal surgery (except simple appendectomy or herniorrhaphy) that may affect assessment of safety and pharmacokinetic characteristics of the IP.
- History of hypersensitivity to iN1011-N17 or to any of its components.
- History of allergy or sensitivity to sulfonamides.
- Any abnormal 12-lead ECG findings at Screening and Day -1, deemed by the Investigator or designee to be clinically significant.
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- Positive test for HBsAg, HCV, or HIV at Screening.
- Positive urine drug screen test (including: amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, phencyclidine and tetrahydrocannabinol) or alcohol breath test at Screening and Day -1.
- History of fracture or other significant injury to dominant arm or current injury or condition, such as carpel tunnel syndrome, that may prevent accurate sensory testing.
- Use of any prescription drugs within 14 days and for OTC medications, herbal remedies (including St John's Wort), dietary supplements or vitamins within 7 days, or five half-lives of the product, whichever is longer, before the first dose of IP and for the duration of the study without prior approval of the Investigator and the MM. This includes analgesics such as paracetamol and non-steroidal anti-inflammatories.
- The use of any IP or investigational medical device within 30 days prior to Screening, or five half-lives of the product, whichever is longer.
- Blood or plasma donation of more than 450 mL within 90 days before the first dose of IP and for the duration of the study. It is recommended that blood/plasma donations not be made for at least 30 days after study completion.
- History of alcoholism, substance or drug abuse-related disorders deemed significant by the Investigator (or designee) (i.e. >21 units per week for males and >14 units per week for females. One unit of alcohol equals ½ pint [285 mL] of beer or lager, 1 glass [125 mL] of wine, or 1/6 gill [25 mL] of spirits).
- Use of more than five nicotine-based products (including smoking tobacco, smokeless tobacco, and nicotine patches) per week, within 90 days prior to Screening. Subjects must have a negative urine cotinine test at both Screening and Day -1 and refrain from the use of any nicotine-based products for the duration of the study.
- Consumption of beverages or foods that contain grapefruit, star fruit, pomelos, or products containing these fruits, from 7 days, or from the time that is deemed significant by the investigator, and products containing caffeine (e.g., coffee, green tea, black tea and sodas) from 72 hours before the first dose of IP until discharge from the unit.
- Unwilling to refrain from strenuous exercise from 48 hours prior to admission to the investigational site/institution and for the duration of the study, where strenuous exercise is defined as that which requires significant effort, energy, or strength, such as lifting weights or running.
- Any other reason that, in the opinion of the Investigator, may affect assessment of safety, PK or PD characteristics of the IP.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single- Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics Properties of iN1011-N17 After Oral Administration in Healthy Volunteers
A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of iN1011-N17 after Oral Administration in Healthy Volunteers.
- Conditions
- Osteoarthritis, Pain, Post Herpetic Neuralgia, Neuropathic Pain, Chronic Pain, Nav 1.7
- Being tested
- iN1011-N17, Placebo
- Keywords
- Nav1.7 Inhibitor, Neuropathic pain, Postoperative pain, Chemotherapy-induced neuropathic pain, Nav 1.7, Pain, Sodium Channel, Volatage Gated Sodium Channel, Voltage Gated Sodium Channel 1.7, DRG Voltage Gated Sodium Channel 1.7, Sodium Channel 1.7
- Medical subject headings
- Osteoarthritis, Pain, Neuralgia, Postherpetic, Neuralgia, Chronic Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iN1011-N17Drug
This study will be conducted in approximately 104 healthy subjects in up to 13 sequential dose cohorts. Thirteen cohorts will consist of up to 8 subjects, including 2 subjects receiving placebo and 6 subjects receiving iN1011-N17.
Each subsequent cohort will continue to be randomized and dosed until maximum exposure is attained or a stopping criterion has been reached.
PlaceboDrug
Matching Placebo for each formulations
| Study group | Role | What they receive |
|---|---|---|
| iN1011-N17, Oral capsule, Single Ascending Dose | Experimental | The IP or placebo will be orally administered in the morning on Day 1, following a 10-hour overnight fast. Receives: Drug: iN1011-N17 |
| iN1011-N17, Oral Suspension, Single Ascending Dose | Experimental | The IP or placebo will be orally administered in the morning on Day 1, following a 10-hour overnight fast. Receives: Drug: iN1011-N17 |
| iN1011-N17, Nanoparticle Capsule, Single Ascending Dose | Experimental | The IP or placebo will be orally administered in the morning on Day 1, following a 10-hour overnight fast. Receives: Drug: iN1011-N17 |
| Placebo | Placebo comparator | The IP or placebo will be orally administered in the morning on Day 1, following a 10-hour overnight fast. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)
Measured: Day 1 to Day 8
Number of participants with abnormal physical examination findings
Full physical examination will consist of the following body systems: general appearance, HEENT (head, ears, eyes, nose, and throat), cardiovascular, respiratory system, abdomen, musculoskeletal, neurological, lymph nodes, skin, and other.
Measured: Screening, Day -1, Day 3, Day 8
Vital Signs (Blood Pressure)
Vital signs (BP) will be listed and summarized at each protocol specified time point. Observed and change from baseline will be summarized at each protocol specified time point.
Measured: Screening, Day -1, Day 1 (pre-dose and 2, 4, 8 hours pose-dose), Day 2 (prior PK sampling), Day 3 (prior PK sampling), Day 8
Vital Signs (Pulse)
Vital signs (Pulse) will be listed and summarized at each protocol specified time point. Observed and change from baseline will be summarized at each protocol specified time point.
Measured: Screening, Day -1, Day 1 (pre-dose and 2, 4, 8 hours pose-dose), Day 2 (prior PK sampling), Day 3 (prior PK sampling), Day 8
Vital Signs (Respiratory Rate)
Vital signs (RR) will be listed and summarized at each protocol specified time point. Observed and change from baseline will be summarized at each protocol specified time point.
Measured: Screening, Day -1, Day 1 (pre-dose and 2, 4, 8 hours pose-dose), Day 2 (prior PK sampling), Day 3 (prior PK sampling), Day 8
Vital Signs (Body temperature)
Vital signs (Body temperature) will be listed and summarized at each protocol specified time point. Observed and change from baseline will be summarized at each protocol specified time point.
Measured: Screening, Day -1, Day 3 (prior PK sampling), Day 8
12-lead electrocardiogram(ECG)
ECG values will consist of QT interval, PR interval, QRS interval, RR interval and QTcF. Values will be listed and summarized at each protocol specified time point. Observed and change from baseline will be summarized at each protocol specified time point.
Measured: Screening, Day -1, Day 1 (pre-dose and 1, 4, 8 hours pose-dose), Day 3 (prior PK sampling), Day 8
Number of participants with abnormal Laboratory tests (Hematology)
Laboratory evaluations will be listed and summarized for each scheduled visit. Observed and change from baseline clinical laboratory data will be summarized at each protocol specified time point.
Measured: Screening, Day -1, Day 3 prior to discharge, Day 8
Number of participants with abnormal Laboratory tests (Biochemistry))
Laboratory evaluations will be listed and summarized for each scheduled visit. Observed and change from baseline clinical laboratory data will be summarized at each protocol specified time point.
Measured: Screening, Day -1, Day 3 prior to discharge, Day 8
Secondary outcomes (10)
Maximum plasma concentration (Cmax)
Measured: 0-48 hours post dose
Time to maximum plasma concentration (tmax)
Measured: 0-48 hours post dose
Terminal half-life (t1/2)
Measured: 0-48 hours post dose
Area under the plasma concentration curve (AUClast, AUCinf)
Measured: 0-48 hours post dose
Apparent volume of distribution (Vz/F)
Measured: 0-48 hours post dose on Day 1 to Day 3
Apparent plasma elimination rate constant (λz)
Measured: 0-48 hours post dose on Day 1 to Day 3
Apparent clearance (CL/F)
Measured: 0-48 hours post dose on Day 1 to Day 3
Fraction excreted unchanged in urine (fe)
Measured: 0-48 hours post dose on Day 1 to Day 3
Amount of drug excreted unchanged in the urine (Ae)
Measured: 0-48 hours post dose on Day 1 to Day 3
Renal clearance (CLR)
Measured: 0-48 hours post dose on Day 1 to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start30 Sep 2020
- Primary completion8 Oct 2023
- Study completion8 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- iN Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496205
- Sponsor's protocol ID
- DW_DWP17061101
- Status last verified
- Dec 2023
- First submitted
- 30 May 2022
- Last updated
- 21 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single- Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics Properties of iN1011-N17 After Oral Administration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05496205
- Acronym / sponsor ID
- DW_DWP17061101
- Conditions
- Osteoarthritis, Pain, Post Herpetic Neuralgia, Neuropathic Pain, Chronic Pain, Nav 1.7
- Keywords
- Nav1.7 Inhibitor, Neuropathic pain, Postoperative pain, Chemotherapy-induced neuropathic pain, Nav 1.7, Pain, Sodium Channel, Volatage Gated Sodium Channel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- iN Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 8 Oct 2023 (actual)
- Study completion
- 8 Oct 2023 (actual)
- First posted
- 11 Aug 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.
A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of iN1011-N17 after Oral Administration in Healthy Volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| iN1011-N17, Oral capsule, Single Ascending Dose | Experimental | Drug: iN1011-N17The IP or placebo will be orally administered in the morning on Day 1, following a 10-hour overnight fast. |
| iN1011-N17, Oral Suspension, Single Ascending Dose | Experimental | Drug: iN1011-N17The IP or placebo will be orally administered in the morning on Day 1, following a 10-hour overnight fast. |
| iN1011-N17, Nanoparticle Capsule, Single Ascending Dose | Experimental | Drug: iN1011-N17The IP or placebo will be orally administered in the morning on Day 1, following a 10-hour overnight fast. |
| Placebo | Placebo comparator | Drug: PlaceboThe IP or placebo will be orally administered in the morning on Day 1, following a 10-hour overnight fast. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (25 listed)
- Healthy male and female adults aged 18 to 55 years (inclusive at the time of written informed consent).
- Body mass index (BMI = body weight (kg)/[height (m)]2) between 18 kg/m2 and 32 kg/m2 (inclusive) at the time of Screening, and a minimum weight of 50 kg.
- Clinical laboratory values within normal range as specified by the testing laboratory at Screening and Day -1, unless deemed not clinically significant by the Investigator.
- Clinically acceptable blood pressure (BP), pulse, respiratory rate (RR), and body temperature (SBP between 90 and 140 mmHg; DBP between 40 and 90 mmHg; pulse between 40 and 100 bpm; RR between 10 and 22 breaths/min; body temperature between 35.5°C and 37.5°C) at Screening and Day -1. Measurements are to be recorded after a minimum of 5 minutes of resting in sitting or supine position.
- Female subjects must be of non-child-bearing potential, defined as:
Key exclusion criteria (17 listed)
- Presence or history of hepatic, renal, neurological, pulmonary, endocrine, hematologic, cardiovascular or genitourinary disease that, in the opinion of the Investigator, may affect the evaluation of the investigational product or place the participant at undue risk.
- Presence of any underlying physical or psychiatric condition that, in the opinion of the Investigator, would undermine subject compliance to protocol requirements.
- Presence or history of gastrointestinal disease (e.g., peptic ulcer, gastritis, gastric cramp, gastroesophageal reflex disease, Crohn's disease) or history of gastrointestinal surgery (except simple appendectomy or herniorrhaphy) that may affect assessment of safety and pharmacokinetic characteristics of the IP.
- History of hypersensitivity to iN1011-N17 or to any of its components.
- History of allergy or sensitivity to sulfonamides.
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 |
|---|---|---|
| iN1011-N17This study will be conducted in approximately 104 healthy subjects in up to 13 sequential dose cohorts. Thirteen cohorts will consist of up to 8 subjects, including 2 subjects receiving placebo and 6 subjects receiving iN1011-N17. Each subsequent cohort will continue to be randomized and dosed until maximum exposure is attained or a stopping criterion has been reached. | Drug | iN1011-N17, Nanoparticle Capsule, Single Ascending Dose, iN1011-N17, Oral Suspension, Single Ascending Dose, iN1011-N17, Oral capsule, Single Ascending Dose |
| PlaceboMatching Placebo for each formulations | Drug | Placebo |
Primary outcome
Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Day 1 to Day 8
Number of participants with abnormal physical examination findings
Time frame: Screening, Day -1, Day 3, Day 8
Full physical examination will consist of the following body systems: general appearance, HEENT (head, ears, eyes, nose, and throat), cardiovascular, respiratory system, abdomen, musculoskeletal, neurological, lymph nodes, skin, and other.
Vital Signs (Blood Pressure)
Time frame: Screening, Day -1, Day 1 (pre-dose and 2, 4, 8 hours pose-dose), Day 2 (prior PK sampling), Day 3 (prior PK sampling), Day 8
Vital signs (BP) will be listed and summarized at each protocol specified time point. Observed and change from baseline will be summarized at each protocol specified time point.
Vital Signs (Pulse)
Time frame: Screening, Day -1, Day 1 (pre-dose and 2, 4, 8 hours pose-dose), Day 2 (prior PK sampling), Day 3 (prior PK sampling), Day 8
Vital signs (Pulse) will be listed and summarized at each protocol specified time point. Observed and change from baseline will be summarized at each protocol specified time point.
Vital Signs (Respiratory Rate)
Time frame: Screening, Day -1, Day 1 (pre-dose and 2, 4, 8 hours pose-dose), Day 2 (prior PK sampling), Day 3 (prior PK sampling), Day 8
Vital signs (RR) will be listed and summarized at each protocol specified time point. Observed and change from baseline will be summarized at each protocol specified time point.
Vital Signs (Body temperature)
Time frame: Screening, Day -1, Day 3 (prior PK sampling), Day 8
Vital signs (Body temperature) will be listed and summarized at each protocol specified time point. Observed and change from baseline will be summarized at each protocol specified time point.
12-lead electrocardiogram(ECG)
Time frame: Screening, Day -1, Day 1 (pre-dose and 1, 4, 8 hours pose-dose), Day 3 (prior PK sampling), Day 8
ECG values will consist of QT interval, PR interval, QRS interval, RR interval and QTcF. Values will be listed and summarized at each protocol specified time point. Observed and change from baseline will be summarized at each protocol specified time point.
Number of participants with abnormal Laboratory tests (Hematology)
Time frame: Screening, Day -1, Day 3 prior to discharge, Day 8
Laboratory evaluations will be listed and summarized for each scheduled visit. Observed and change from baseline clinical laboratory data will be summarized at each protocol specified time point.
Number of participants with abnormal Laboratory tests (Biochemistry))
Time frame: Screening, Day -1, Day 3 prior to discharge, Day 8
Laboratory evaluations will be listed and summarized for each scheduled visit. Observed and change from baseline clinical laboratory data will be summarized at each protocol specified time point.
10 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: 0-48 hours post dose
Time to maximum plasma concentration (tmax)
Time frame: 0-48 hours post dose
Terminal half-life (t1/2)
Time frame: 0-48 hours post dose
Area under the plasma concentration curve (AUClast, AUCinf)
Time frame: 0-48 hours post dose
Apparent volume of distribution (Vz/F)
Time frame: 0-48 hours post dose on Day 1 to Day 3
Apparent plasma elimination rate constant (λz)
Time frame: 0-48 hours post dose on Day 1 to Day 3
Apparent clearance (CL/F)
Time frame: 0-48 hours post dose on Day 1 to Day 3
Fraction excreted unchanged in urine (fe)
Time frame: 0-48 hours post dose on Day 1 to Day 3
Amount of drug excreted unchanged in the urine (Ae)
Time frame: 0-48 hours post dose on Day 1 to Day 3
Renal clearance (CLR)
Time frame: 0-48 hours post dose on Day 1 to Day 3
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 21 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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 iN1011-N17 in people with Osteoarthritis and Pain, run by iN Therapeutics Co., 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 25 inclusion and 17 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 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. 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?
Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs) (time frame: Day 1 to Day 8). 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 21 Jun 2024.