HealthyPhase 1NCT05701644
Study To Evaluate the Safety, Tolerability, and Pharmacokinetics After Subcutaneous Administration of C1K in Healthy Subjects
A Phase 1 study testing C1K 150mg, C1K 300mg and C1K 600mg in people with Healthy, run by Ensol Bioscience at 1 site in South Korea.
Trial summary
A dose-block randomized, double-blind, placebo-controlled, single and multiple ascending dose, first-in-human, phase 1 first in human clinical trial to evaluate the safety, tolerability, and pharmacokinetics after subcutaneous administration of C1K in healthy Korean subjects. Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- C1K 150mg, C1K 300mg and C1K 600mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2023to 28 Jun 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 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects aged 19 - 45 years at the time of screening visit procedure.
- The subject weighs in the range of 50.0 - 90.0 kg and has a body mass index (BMI) in the range 18-27 kg/m2.
- Sufficient ability to understand the study after being informed about the study and provide written informed consent.
- Based on physical examination, vital sign, 12-lead ECG and laboratory test etc. and in the opinion of the investigator, the subject is suitable for the study.
Who cannot join
- A subject with clinically significant hepatobiliary, renal, neurologic, respiratory, endocrine, blood•oncology, cardiovascular, urinary, or, psychical diseases or a history
- A subject who has difficulty with sub-cutaneous injection(ex: tattoo, allergy on skin etc.)
- A subject who has hypersensitivity to the drugs of the drugs containing the same class, or other drugs, or a history of clinically significant hypersensitivity
- A subject who has ventricular tachycardia, ventricular tachycardia, ventricular flutter or confirmed other ventricular flutter and QTc interval: > 450 ms or the other clinically significant medical findings
- A subject with the following results in the screening test:
- Blood AST (GOT), ALT (GPT): > Normal range upper × 1.5
Show all 25Show fewer
- Blood CPK > Normal range upper × 1.5
- eGFR (CKD-EPI equation) < 60 mL/min/1.73 m2
- Positive serological test (syphilis test, hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test)
- A subject with the following results in the screening test:
- systolic blood pressure < 80 mmHg or > 140 mmHg
- diastolic blood pressure < 50 mmHg or > 90 mmHg
- A subject with a history of drug abuse or positive urine screening test for drug abuse
- A subject who administered any prescription drugs or herbal medicine within 2 weeks prior to the expected date of the first dose, or any over-the-counter drug (OTC drug) or vitamin within 1 week prior to the expected date of the first dose (However, can participate in the study if otherwise decided eligible by the investigator).
- A subject who participated in other clinical trial and administered investigational drug within 6 months prior to the expected date of the first dose
- A subject who donated whole blood within 2 months or the component blood within 1 month prior to the expected date of the first dose, or received blood transfusion within 1 month prior to the expected date of the first dose
- Smokers who smoke more than 10 cigarettes/day in the last 3 months as of screening day.
- A subject with persistent alcohol intake (> 21 units/week, 1 unit = 10 g of pure alcohol), or inability to abstain from drinking from 3 days before the expected date of the first dose until the last discharge
- A male subject who has plan to have a baby or to donate sperm. A female subject who is pregnant or lactating or has plan to lactate within 3 months after administration of IP
- A subject who is intending to become pregnant during this study or with inability to use a medically acceptable contraception method(ex. sterilization operation, intrauterine device etc. for Subject or subject's partner
- ※ medically acceptable contraception method
- Use of intrauterine device which is proven pregnancy failure rates in spouses (or partners).
- Use combined blocking contraceptives (for male or female) and antiseptic drugs
- Subject or partner's operation(vasectomized, bilateral tubal occlusion, hysterectomy)
- Subject who is considered inadequate to participation in the study due to other reason under investigator's discretion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose-block Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, First-in-human, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics After Subcutaneous Administration of C1K in Healthy Subjects
A dose-block randomized, double-blind, placebo-controlled, single and multiple ascending dose, first-in-human, phase 1 first in human clinical trial to evaluate the safety, tolerability, and pharmacokinetics after subcutaneous administration of C1K in healthy Korean subjects.
- Conditions
- Healthy
- Being tested
- C1K 150mg, C1K 300mg, Placebo with the same volume of C1K 300mg, C1K 600mg, Placebo with the same volume of C1K 600mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C1K 150mgDrug
Subcutaneously administrate C1K 150mg at Day 1, Day 8, Day 15
C1K 300mgDrug
Subcutaneously administrate C1K 300mg at Day 1, Day 8, Day 15
Placebo with the same volume of C1K 300mgDrug
Subcutaneously administrate placebo with the same volume of C1K 300mg at Day 1, Day 8, Day 15
C1K 600mgDrug
Subcutaneously administrate C1K 600mg at Day 1, Day 8, Day 15
Placebo with the same volume of C1K 600mgDrug
Subcutaneously administrate placebo with the same volume of C1K 600mg at Day 1, Day 8, Day 15
C1K 900mgDrug
Subcutaneously administrate C1K 900mg at Day 1, Day 8, Day 15
Placebo with the same volume of C1K 900mgDrug
Subcutaneously administrate placebo with the same volume of C1K 900mg at Day 1, Day 8, Day 15
C1K 1200mgDrug
Subcutaneously administrate C1K 1200mg at Day 1, Day 8, Day 15
Placebo with the same volume of C1K 1200mgDrug
Subcutaneously administrate placebo with the same volume of C1K 1200mg at Day 1, Day 8, Day 15
| Study group | Role | What they receive |
|---|---|---|
| C1K 150mg | Experimental | Subcutaneous Administration C1K 150mg single or multi dose Receives: Drug: C1K 150mg |
| C1K 300mg or placebo | Experimental | Subcutaneous Administration C1K 300mg or placebo single or multi dose Receives: Drug: C1K 300mg; Drug: Placebo with the same volume of C1K 300mg |
| C1K 600mg or placebo | Experimental | Subcutaneous Administration C1K 600mg or placebo single or multi dose Receives: Drug: C1K 600mg; Drug: Placebo with the same volume of C1K 600mg |
| C1K 900mg or placebo | Experimental | Subcutaneous Administration C1K 900mg or placebo single or multi dose Receives: Drug: C1K 900mg; Drug: Placebo with the same volume of C1K 900mg |
| C1K 1200mg or placebo | Experimental | Subcutaneous Administration C1K 1200mg or placebo single or multi dose Receives: Drug: C1K 1200mg; Drug: Placebo with the same volume of C1K 1200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability Assessment
Percentage of occurrences observed Adverse Event in each group.
Measured: Day -1 to Day 23
Safety and Tolerability Assessment by Value Changes in Vital Signs
Vital Signs including blood pressure and heart rate changes from baseline.
Measured: Day -1 to Day 23
Safety and Tolerability Assessment by Value Changes in Physical Examination
physical examination changes from baseline.
Measured: Day -1 to Day 23
Safety and Tolerability Assessment by Value Changes in Laboratory Test
laboratory test changes from baseline assessed through hematology, blood biochemistry, urinalysis and blood coagulation.
Measured: Day -1 to Day 23
Safety and Tolerability Assessment by Value Changes in 12-Lead Electrocardiogram
12-Lead Electrocardiogram(ECG) changes from baseline.
Measured: Day -1 to Day 23
Safety and Tolerability Assessment by Response Change of Injection site.
Percentage of occurrences observed response change of injection site.
Measured: Day 1 to Day 23
Pharmacokinetic Assessment by Maximum concentration of C1K in plasma
Maximum concentration of C1K in plasma (Cmax)
Measured: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of C1K from Time Zero to the Last Measurable Point
Area under the plasma C1K concentration-time curve from 0 to last(AUClast)
Measured: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by Area under the plasma C1K concentration-time curve from 0 to infinity
Area under the plasma C1K concentration-time curve from 0 to last(AUCinf)
Measured: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by The time of peak concentration of C1K
The time of peak concentration(Tmax)
Measured: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by Elimination half-life of C1K
Elimination half-life(t1/2)
Measured: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by Apparent Clearance of C1K
Apparent Clearance(CL/F)
Measured: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by Apparent Volume of Distribution After extravascular administration of C1K
Apparent Volume of Distribution After extravascular administration(Vz/F)
Measured: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by Accumulation Ratio of C1K
Accumulation Ratio(Rac)
Measured: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by Minimum concentration of C1K in plasma
Minimum concentration of C1K in plasma(Cmin,ss)
Measured: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by Average concentration of C1K in plasma
Average concentration of C1K in plasma(Cav)
Measured: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Pharmacokinetic Assessment by Peak to trough fluctuation ratio
Peak to trough fluctuation ratio(PTF)
Measured: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start2 Jan 2023
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
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.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ensol Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701644
- Sponsor's protocol ID
- C1K-101
- Status last verified
- Jan 2023
- First submitted
- 22 Dec 2022
- Last updated
- 4 Apr 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 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-block Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose, First-in-human, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics After Subcutaneous Administration of C1K in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05701644
- Acronym / sponsor ID
- C1K-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ensol BioscienceIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 27 Jan 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.
A dose-block randomized, double-blind, placebo-controlled, single and multiple ascending dose, first-in-human, phase 1 first in human clinical trial to evaluate the safety, tolerability, and pharmacokinetics after subcutaneous administration of C1K in healthy Korean subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| C1K 150mg | Experimental | Drug: C1K 150mgSubcutaneous Administration C1K 150mg single or multi dose |
| C1K 300mg or placebo | Experimental | Drug: C1K 300mg, Drug: Placebo with the same volume of C1K 300mgSubcutaneous Administration C1K 300mg or placebo single or multi dose |
| C1K 600mg or placebo | Experimental | Drug: C1K 600mg, Drug: Placebo with the same volume of C1K 600mgSubcutaneous Administration C1K 600mg or placebo single or multi dose |
| C1K 900mg or placebo | Experimental | Drug: C1K 900mg, Drug: Placebo with the same volume of C1K 900mgSubcutaneous Administration C1K 900mg or placebo single or multi dose |
| C1K 1200mg or placebo | Experimental | Drug: C1K 1200mg, Drug: Placebo with the same volume of C1K 1200mgSubcutaneous Administration C1K 1200mg or placebo single or multi dose |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects aged 19 - 45 years at the time of screening visit procedure.
- The subject weighs in the range of 50.0 - 90.0 kg and has a body mass index (BMI) in the range 18-27 kg/m2.
- Sufficient ability to understand the study after being informed about the study and provide written informed consent.
- Based on physical examination, vital sign, 12-lead ECG and laboratory test etc. and in the opinion of the investigator, the subject is suitable for the study.
Key exclusion criteria (25 listed)
- A subject with clinically significant hepatobiliary, renal, neurologic, respiratory, endocrine, blood•oncology, cardiovascular, urinary, or, psychical diseases or a history
- A subject who has difficulty with sub-cutaneous injection(ex: tattoo, allergy on skin etc.)
- A subject who has hypersensitivity to the drugs of the drugs containing the same class, or other drugs, or a history of clinically significant hypersensitivity
- A subject who has ventricular tachycardia, ventricular tachycardia, ventricular flutter or confirmed other ventricular flutter and QTc interval: > 450 ms or the other clinically significant medical findings
- A subject with the following results in the screening test:
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 |
|---|---|---|
| C1K 150mgSubcutaneously administrate C1K 150mg at Day 1, Day 8, Day 15 | Drug | C1K 150mg |
| C1K 300mgSubcutaneously administrate C1K 300mg at Day 1, Day 8, Day 15 | Drug | C1K 300mg or placebo |
| Placebo with the same volume of C1K 300mgSubcutaneously administrate placebo with the same volume of C1K 300mg at Day 1, Day 8, Day 15 | Drug | C1K 300mg or placebo |
| C1K 600mgSubcutaneously administrate C1K 600mg at Day 1, Day 8, Day 15 | Drug | C1K 600mg or placebo |
| Placebo with the same volume of C1K 600mgSubcutaneously administrate placebo with the same volume of C1K 600mg at Day 1, Day 8, Day 15 | Drug | C1K 600mg or placebo |
| C1K 900mgSubcutaneously administrate C1K 900mg at Day 1, Day 8, Day 15 | Drug | C1K 900mg or placebo |
| Placebo with the same volume of C1K 900mgSubcutaneously administrate placebo with the same volume of C1K 900mg at Day 1, Day 8, Day 15 | Drug | C1K 900mg or placebo |
| C1K 1200mgSubcutaneously administrate C1K 1200mg at Day 1, Day 8, Day 15 | Drug | C1K 1200mg or placebo |
| Placebo with the same volume of C1K 1200mgSubcutaneously administrate placebo with the same volume of C1K 1200mg at Day 1, Day 8, Day 15 | Drug | C1K 1200mg or placebo |
Primary outcome
Safety and Tolerability Assessment
Time frame: Day -1 to Day 23
Percentage of occurrences observed Adverse Event in each group.
Safety and Tolerability Assessment by Value Changes in Vital Signs
Time frame: Day -1 to Day 23
Vital Signs including blood pressure and heart rate changes from baseline.
Safety and Tolerability Assessment by Value Changes in Physical Examination
Time frame: Day -1 to Day 23
physical examination changes from baseline.
Safety and Tolerability Assessment by Value Changes in Laboratory Test
Time frame: Day -1 to Day 23
laboratory test changes from baseline assessed through hematology, blood biochemistry, urinalysis and blood coagulation.
Safety and Tolerability Assessment by Value Changes in 12-Lead Electrocardiogram
Time frame: Day -1 to Day 23
12-Lead Electrocardiogram(ECG) changes from baseline.
Safety and Tolerability Assessment by Response Change of Injection site.
Time frame: Day 1 to Day 23
Percentage of occurrences observed response change of injection site.
Pharmacokinetic Assessment by Maximum concentration of C1K in plasma
Time frame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Maximum concentration of C1K in plasma (Cmax)
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of C1K from Time Zero to the Last Measurable Point
Time frame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Area under the plasma C1K concentration-time curve from 0 to last(AUClast)
Pharmacokinetic Assessment by Area under the plasma C1K concentration-time curve from 0 to infinity
Time frame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Area under the plasma C1K concentration-time curve from 0 to last(AUCinf)
Pharmacokinetic Assessment by The time of peak concentration of C1K
Time frame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
The time of peak concentration(Tmax)
Pharmacokinetic Assessment by Elimination half-life of C1K
Time frame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Elimination half-life(t1/2)
Pharmacokinetic Assessment by Apparent Clearance of C1K
Time frame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Apparent Clearance(CL/F)
Pharmacokinetic Assessment by Apparent Volume of Distribution After extravascular administration of C1K
Time frame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Apparent Volume of Distribution After extravascular administration(Vz/F)
Pharmacokinetic Assessment by Accumulation Ratio of C1K
Time frame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Accumulation Ratio(Rac)
Pharmacokinetic Assessment by Minimum concentration of C1K in plasma
Time frame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Minimum concentration of C1K in plasma(Cmin,ss)
Pharmacokinetic Assessment by Average concentration of C1K in plasma
Time frame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Average concentration of C1K in plasma(Cav)
Pharmacokinetic Assessment by Peak to trough fluctuation ratio
Time frame: Day 1/ Day 15 pre-dose(0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hour at Day 1 and Day 15
Peak to trough fluctuation ratio(PTF)
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 4 Apr 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.
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 C1K 150mg, C1K 300mg and C1K 600mg in people with Healthy, run by Ensol Bioscience 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 4 inclusion and 25 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 4 Apr 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. 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?
Safety and Tolerability Assessment (time frame: Day -1 to Day 23). The study lists 17 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 4 Apr 2024.