Safety IssuesPhase 1NCT05795192
SB17170 Phase1 Trial in Healthy Volunteer
A Phase 1 study testing SB17170 in people with Safety Issues and Tolerability, run by SPARK Biopharma at 1 site in South Korea.
Trial summary
This clinical trial aims to learn about the safety, tolerability, and pharmacokinetic properties of SB17170 and its active metabolite SB1703 in single and multiple oral administration in healthy adults. Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety Issues, Tolerability, Pharmacokinetics
- What is being tested?
- SB17170
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 May 2023to 15 Mar 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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Korean or Caucasian adults between the ages of 19 and 50 as of the date of written consent
- Subjects with a body weight of 55.0 kg or more at the time of screening and a body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0 kg/m2
- Written informed consent
Who cannot join
- Clinical significant medical history
- Gastrointestinal disease or past history
- Hypersensitivity or clinically significant hypersensitivity to the components of investigational drugs
- Screening test AST, ALT > ULN x 1.5 Creatinine clearance < 60mL/min/1.73m2 QTcB interval > 450 ms Serologic test positive(Hepatitis B, Hepatitis C, HIV)
- SBP <90 mmHg or >150 mmHg, DBP <60 mmHg or > 100 mmHg
- Drub abuse history
- Administration of any OTC drug, Herbal drug, Investigational medication within 2weeks
- Participation in other clinical trial within 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, PK/PD, Food Effect, and Ethnicity Effect of SB17170 in Healthy Adult Subjects
This clinical trial aims to learn about the safety, tolerability, and pharmacokinetic properties of SB17170 and its active metabolite SB1703 in single and multiple oral administration in healthy adults.
The main questions it aims to answer are the safety, tolerability, and PK characteristics of SB17170 in healthy adults.
Read the detailed description
This clinical trial aims to learn about the safety, tolerability, and Pharmacokinetic properties of SB17170 and its active metabolite SB1703 in single and multiple oral administration in healthy adults.
The main questions it aims to answer are the safety, tolerability, and PK characteristics of SB17170 in healthy adults.
The second questions are
- To explore biomarkers and evaluate pharmacodynamic properties with ex-vivo test and proteome assay for SB17170
- To evaluate the effects of ethnic differences on the safety, tolerability, and pharmacokinetic properties of SB17170 in healthy Korean and Caucasian adults.
- To evaluate the effect of food between Fast and high-fat meals on safety, tolerability, and pharmacokinetic properties of SB17170 in healthy adults.
The difference between SB17170 and placebo on safety, tolerability, and PK/PD properties will be evaluated.
- Conditions
- Safety Issues, Tolerability, Pharmacokinetics, Pharmacodynamics
- Being tested
- SB17170, Placebo
- Keywords
- HMGB1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB17170Drug
Taking SB17170 orally once a day
PlaceboDrug
Taking Placebo orally once a day
| Study group | Role | What they receive |
|---|---|---|
| SB17170 of 50mg, Single dose | Experimental | Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 50mg capsule, QD for 1 day(single). Receives: Drug: SB17170 |
| Placebo of 50mg, Single dose | Placebo comparator | Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 50mg, QD for 1 day(single). Receives: Drug: Placebo |
| SB17170 of 150mg, Single dose | Experimental | Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 100mg and 50mg capsules, QD for 1 day(single). Receives: Drug: SB17170 |
| Placebo of 150mg, Single dose | Placebo comparator | Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 100mg and 50mg capsules, QD for 1 day(single). Receives: Drug: Placebo |
| SB17170 of 250mg, Single dose | Experimental | Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg capsule, QD for 1 day(single). Receives: Drug: SB17170 |
| Placebo of 250mg, Single dose | Placebo comparator | Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg capsule, QD for 1 day(single). Receives: Drug: Placebo |
| SB17170 of 500mg, Single dose, Food-effect | Experimental | Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 2 capsules, QD for 1 day(single).
Food-effect test for the expected efficacy dose
* 1st period without a meal
* Wash out period more than 7 days
* 2nd period with a high-fat meal Receives: Drug: SB17170 |
| Placebo of 500mg, Single dose, Food-effect | Placebo comparator | Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 2 250mg 2 capsules, QD for 1 day(single).
Food-effect test for the expected efficacy dose
* 1st period without a meal
* Wash out period more than 7 days
* 2nd period with a high-fat meal Receives: Drug: Placebo |
| SB17170 of 1000mg, Single dose | Experimental | Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 4capsules, QD for 1 day(single). Receives: Drug: SB17170 |
| Placebo of 1000mg, Single dose | Placebo comparator | Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 2 250mg 4 capsules, QD for 1 day(single). Receives: Drug: Placebo |
| SB17170 of 1500mg, Single dose | Experimental | Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 6 capsules, QD for 1 day(single). Receives: Drug: SB17170 |
| Placebo of 1500mg, Single dose | Placebo comparator | Optional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg 6 capsules, QD for 1 day(single). Receives: Drug: Placebo |
| SB17170 of 250mg, Multiple dose for 7days | Experimental | Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 1 capsule, QD for 7 days(multiple). Receives: Drug: SB17170 |
| Placebo of 250mg, Multiple dose for 7days | Placebo comparator | Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 1 capsule, QD for 7 days(multiple). Receives: Drug: Placebo |
| SB17170 of 500mg, Multiple dose for 7days | Experimental | Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 2 capsules, QD for 7 days(multiple). Receives: Drug: SB17170 |
| Placebo of 500mg, Multiple dose for 7days | Placebo comparator | Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 2 capsules, QD for 7 days(multiple). Receives: Drug: Placebo |
| SB17170 of 1000mg, Multiple dose for 7days | Experimental | Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 4 capsules, QD for 7 days(multiple). Receives: Drug: SB17170 |
| Placebo of 1000mg, Multiple dose for 7days | Placebo comparator | Optional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 4 capsules, QD for 7 days(multiple). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety and Tolerability in healthy subjects
Measured: From Day 1 to Day 7 for Single dose, From Day 1 to Day 9 for Multiple dose
Secondary outcomes (11)
The Area Under the Curve from dosing to the time of the last measured concentration
Pharmacokinetic parameter
Measured: Baseline 0hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The area under the curve from time 0 extrapolated to infinite time(AUCinf)
Pharmacokinetic parameter
Measured: Baseline 0hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The maximum (or peak) serum concentration(Cmax)
Pharmacokinetic parameter
Measured: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The time to reach Cmax(Tmax)
Pharmacokinetic parameter
Measured: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The Half life(t1/2) of SB17170 and active metabolite
Pharmacokinetic parameter
Measured: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The ratio of oral clearance(CL/F)
Pharmacokinetic parameter
Measured: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The Renal clearance(CLR)
Pharmacokinetic parameter
Measured: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The volume of distribution(vd/f)
Pharmacokinetic parameter
Measured: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The ratio of unchanged drug to metabolite(Metabolic ratio)
Pharmacokinetic parameter
Measured: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
Compare the concentrations of TNF-α between the active and placebo groups
Tumor Necrosis Factor-alpha human(TNF-α) as a Pharmacodynamic parameter
Measured: Baseline 0 hour, 1.5hour, 24hour,
Compare the concentratiosn of Interleukin-6 between the active and placebo groups
Interleukin-6 as a Pharmacodynamic parameter
Measured: Baseline 0 hour, 1.5hour, 24hour,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start24 May 2023
- Primary completion29 Feb 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety IssuesStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPARK Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SeungHwan Lee, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795192
- Sponsor's protocol ID
- SMARTT-002
- Status last verified
- Mar 2024
- First submitted
- 27 Feb 2023
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, PK/PD, Food Effect, and Ethnicity Effect of SB17170 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05795192
- Acronym / sponsor ID
- SMARTT-002
- Conditions
- Safety Issues, Tolerability, Pharmacokinetics, Pharmacodynamics
- Keywords
- HMGB1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- SPARK BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 24 May 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 3 Apr 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 clinical trial aims to learn about the safety, tolerability, and pharmacokinetic properties of SB17170 and its active metabolite SB1703 in single and multiple oral administration in healthy adults.
The main questions it aims to answer are the safety, tolerability, and PK characteristics of SB17170 in healthy adults.
Detailed description
This clinical trial aims to learn about the safety, tolerability, and Pharmacokinetic properties of SB17170 and its active metabolite SB1703 in single and multiple oral administration in healthy adults.
The main questions it aims to answer are the safety, tolerability, and PK characteristics of SB17170 in healthy adults.
The second questions are
- To explore biomarkers and evaluate pharmacodynamic properties with ex-vivo test and proteome assay for SB17170
- To evaluate the effects of ethnic differences on the safety, tolerability, and pharmacokinetic properties of SB17170 in healthy Korean and Caucasian adults.
- To evaluate the effect of food between Fast and high-fat meals on safety, tolerability, and pharmacokinetic properties of SB17170 in healthy adults.
The difference between SB17170 and placebo on safety, tolerability, and PK/PD properties will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| SB17170 of 50mg, Single dose | Experimental | Drug: SB17170Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 50mg capsule, QD for 1 day(single). |
| Placebo of 50mg, Single dose | Placebo comparator | Drug: PlaceboAssign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 50mg, QD for 1 day(single). |
| SB17170 of 150mg, Single dose | Experimental | Drug: SB17170Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 100mg and 50mg capsules, QD for 1 day(single). |
| Placebo of 150mg, Single dose | Placebo comparator | Drug: PlaceboAssign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 100mg and 50mg capsules, QD for 1 day(single). |
| SB17170 of 250mg, Single dose | Experimental | Drug: SB17170Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg capsule, QD for 1 day(single). |
| Placebo of 250mg, Single dose | Placebo comparator | Drug: PlaceboAssign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg capsule, QD for 1 day(single). |
| SB17170 of 500mg, Single dose, Food-effect | Experimental | Drug: SB17170Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 2 capsules, QD for 1 day(single). Food-effect test for the expected efficacy dose * 1st period without a meal * Wash out period more than 7 days * 2nd period with a high-fat meal |
| Placebo of 500mg, Single dose, Food-effect | Placebo comparator | Drug: PlaceboAssign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 2 250mg 2 capsules, QD for 1 day(single). Food-effect test for the expected efficacy dose * 1st period without a meal * Wash out period more than 7 days * 2nd period with a high-fat meal |
| SB17170 of 1000mg, Single dose | Experimental | Drug: SB17170Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 4capsules, QD for 1 day(single). |
| Placebo of 1000mg, Single dose | Placebo comparator | Drug: PlaceboAssign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 2 250mg 4 capsules, QD for 1 day(single). |
| SB17170 of 1500mg, Single dose | Experimental | Drug: SB17170Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg 6 capsules, QD for 1 day(single). |
| Placebo of 1500mg, Single dose | Placebo comparator | Drug: PlaceboOptional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg 6 capsules, QD for 1 day(single). |
| SB17170 of 250mg, Multiple dose for 7days | Experimental | Drug: SB17170Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 1 capsule, QD for 7 days(multiple). |
| Placebo of 250mg, Multiple dose for 7days | Placebo comparator | Drug: PlaceboAssign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 1 capsule, QD for 7 days(multiple). |
| SB17170 of 500mg, Multiple dose for 7days | Experimental | Drug: SB17170Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 2 capsules, QD for 7 days(multiple). |
| Placebo of 500mg, Multiple dose for 7days | Placebo comparator | Drug: PlaceboAssign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 2 capsules, QD for 7 days(multiple). |
| SB17170 of 1000mg, Multiple dose for 7days | Experimental | Drug: SB17170Optional dose Assign 6 subjects per cohort including Korean and Caucasian. Prescribe SB17170 250mg, 4 capsules, QD for 7 days(multiple). |
| Placebo of 1000mg, Multiple dose for 7days | Placebo comparator | Drug: PlaceboOptional dose Assign 2 subjects per cohort including Korean and Caucasian. Prescribe Placebo 250mg, 4 capsules, QD for 7 days(multiple). |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Korean or Caucasian adults between the ages of 19 and 50 as of the date of written consent
- Subjects with a body weight of 55.0 kg or more at the time of screening and a body mass index (BMI) of 18.0 kg/m2 or more and less than 30.0 kg/m2
- Written informed consent
Key exclusion criteria (8 listed)
- Clinical significant medical history
- Gastrointestinal disease or past history
- Hypersensitivity or clinically significant hypersensitivity to the components of investigational drugs
- Screening test AST, ALT > ULN x 1.5 Creatinine clearance < 60mL/min/1.73m2 QTcB interval > 450 ms Serologic test positive(Hepatitis B, Hepatitis C, HIV)
- SBP <90 mmHg or >150 mmHg, DBP <60 mmHg or > 100 mmHg
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 |
|---|---|---|
| SB17170Taking SB17170 orally once a day | Drug | SB17170 of 1000mg, Multiple dose for 7days, SB17170 of 1000mg, Single dose, SB17170 of 1500mg, Single dose, SB17170 of 150mg, Single dose, SB17170 of 250mg, Multiple dose for 7days, SB17170 of 250mg, Single dose, SB17170 of 500mg, Multiple dose for 7days, SB17170 of 500mg, Single dose, Food-effect, SB17170 of 50mg, Single dose |
| PlaceboTaking Placebo orally once a day | Drug | Placebo of 1000mg, Multiple dose for 7days, Placebo of 1000mg, Single dose, Placebo of 1500mg, Single dose, Placebo of 150mg, Single dose, Placebo of 250mg, Multiple dose for 7days, Placebo of 250mg, Single dose, Placebo of 500mg, Multiple dose for 7days, Placebo of 500mg, Single dose, Food-effect, Placebo of 50mg, Single dose |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From Day 1 to Day 7 for Single dose, From Day 1 to Day 9 for Multiple dose
Safety and Tolerability in healthy subjects
11 secondary outcomes
The Area Under the Curve from dosing to the time of the last measured concentration
Time frame: Baseline 0hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The area under the curve from time 0 extrapolated to infinite time(AUCinf)
Time frame: Baseline 0hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The maximum (or peak) serum concentration(Cmax)
Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The time to reach Cmax(Tmax)
Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The Half life(t1/2) of SB17170 and active metabolite
Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The ratio of oral clearance(CL/F)
Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The Renal clearance(CLR)
Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The volume of distribution(vd/f)
Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
The ratio of unchanged drug to metabolite(Metabolic ratio)
Time frame: Baseline 0 hour, 20minute, 40minute, 1hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour, 24hour, 48hour
Compare the concentrations of TNF-α between the active and placebo groups
Time frame: Baseline 0 hour, 1.5hour, 24hour,
Compare the concentratiosn of Interleukin-6 between the active and placebo groups
Time frame: Baseline 0 hour, 1.5hour, 24hour,
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 Mar 2024.
- Individual participant dataSharing planned: No
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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.
SeungHwan Lee, M.D. principal investigator
Seoul National University Hospital
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 SB17170 in people with Safety Issues and Tolerability, run by SPARK Biopharma at 1 site in South Korea.
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 8 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 Mar 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 South Korea. 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 of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: From Day 1 to Day 7 for Single dose, From Day 1 to Day 9 for Multiple dose). 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 Mar 2024.