HealthyPhase 1NCT04297865
Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CJ-15314 Phosphate in Healthy Male Subjects
A Phase 1 study testing A dose as CJ-15314, B dose as CJ-15314 and C dose as CJ-15314 in people with Healthy, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study aims to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of CJ-15314 phosphate in healthy male subjects. Read more about this study
- Who is it for?
- Ages 19 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- A dose as CJ-15314, B dose as CJ-15314 and C dose as CJ-15314
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Feb 2020to Feb 2021
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male adults aged 19 to 55 years (inclusive) at the time of signing the informed consent form.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m^2 with a body weight ≥ 50.0 kg and ≤ 90.0 kg at screening.
- ☞ BMI (kg/m^2) = weight (kg) / {height (m)}^2
- Decides to participate voluntarily in the study after being fully informed of and understanding the study completely, and provides his written informed consent prior to screening procedure.
- Determined eligible for this study in the opinion of the investigator based on the results of vital signs, physical examination, 12-lead electrocardiogram, clinical laboratory tests, and medical interview drug screening test.
Who cannot join
- Has a history or current evidence of clinically significant disorder of hepatic, renal, nervous, respiratory, endocrine, hemato-oncologic, cardiovascular, urinary, and/or psychiatric system.
- Has a history or current evidence of gastrointestinal disease that may affect the safety and PD assessment of IP or a history of gastrointestinal surgery (except for simple appendectomy or herniotomy).
- Has rheumatoid arthritis or has a history.
- Has symptomatic herpes simplex or herpes zoster or has a history within 3 months prior to the scheduled first dose.
- Has live vaccine dose within 3 months prior to the scheduled first dose or expects to receive live vaccine during the clinical trial period.
- Has a history or current evidence of clinically significant hypersensitivity to drugs containing any ingredient of Janus kinase inhibitor and other drugs.
Show all 22Show fewer
- Has a positive result on serology tests (for hepatitis B, hepatitis C and human immunodeficiency virus [HIV]) during screening test.
- Has abnormalities one or more of the following during screening test: AST [GOT] or ALT [GPT] > 1.5 X upper limit of normal (ULN), Creatinine > upper limit of normal (ULN), ANC < 2,000/uL, Hb <12.5 g/dL, Platelet < 150,000/uL, QTc interval at 12-lead electrocardiogram > 450 msec
- Systolic blood pressure (SBP) < 90 mmHg or > 140 mmHg, diastolic blood pressure (DBP) < 50 mmHg or > 95 mm Hg, or pulse rate (PR) < 45 beats/min or > 100 beats/min on vital signs measured in sitting position after taking a rest for at least 5 minutes during screening test.
- Has a history of drug abuse or has a positive response to drug abuse on urine drug screening test.
- Has taken any prescription drugs or herbal medicine within 2 weeks prior to the expected date of first dose, or has taken or is expected to take any over-the-counter (OTC) drug, health functional food or vitamin preparation within 1 week prior to the expected date of the first dose (However, can participate in the study if otherwise eligible in the judgment of the investigator).
- Has participated in any other clinical study or bioequivalence study and received IPs within 6 months prior to the scheduled first dose.
- Has donated whole blood within 2 months prior to the scheduled first dose, or has donated blood components or received transfusion within a month prior to the scheduled first dose.
- Has a history of excessive smoking (> 10 cigarettes/day) within 3 months prior to the scheduled first dose or confirmed as positive for cotinine on urine drug screening test.
- Excessive caffeine intake (> 5 units/day), continued use of alcohol (> 21 units/week, 1 unit = 10 g of pure alcohol), or unable to stop drinking during hospitalization period.
- Unable to avoid caffeine-containing foods (e.g., coffee, tea [black tea, green tea, etc.], soda, coffee-flavored milk, and nutritive tonic drink) during the period from 24 hrs before hospitalization to discharge.
- Unable to use a medically acceptable contraceptive method throughout the study.
- ► Medically acceptable contraceptive methods include:
- Use of intrauterine device with a proven birth control failure rate by the spouse (or partner)
- Simultaneous use of (male or female) barrier method and spermicide
- Surgical sterilization of the subject or his partner (e.g., vasectomy, salpingectomy, tubal ligation, or hysterectomy)
- Determined ineligible for study participation by the investigator for other reasons such as clinical laboratory abnormalities.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital, Dept. of Clinical Pharmacology
Seoul
In-Jin Jang, MD, PhD, 82-2-2072-1666, ijjang@snu.ac.kr
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CJ-15314 Phosphate in Healthy Male Subjects
This study aims to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of CJ-15314 phosphate in healthy male subjects.
Read the detailed description
- To evaluate the safety, tolerability and pharmacokinetics of single or multiple dose of CJ-15314 phosphate in healthy male subjects
- To explore the pharmacodynamics of single or multiple dose of CJ-15314 phosphate in healthy male subjects
- To explore the pharmacokinetics of CJ-15314 Phosphate active metabolites of single or multiple dose of CJ-15314 phosphate in healthy male subjects
- Conditions
- Healthy
- Being tested
- A dose as CJ-15314, B dose as CJ-15314, C dose as CJ-15314, D dose as CJ-15314, E dose as CJ-15314
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A dose as CJ-15314Drug
A dose as CJ-15314, 1 capsule
B dose as CJ-15314Drug
B dose as CJ-15314, 1 capsule
C dose as CJ-15314Drug
C dose as CJ-15314, 1 capsule
D dose as CJ-15314Drug
D dose as CJ-15314, 2 capsules
E dose as CJ-15314Drug
E dose as CJ-15314, 1 capsule
F dose as CJ-15314Drug
F dose as CJ-15314, 2 capsules
PlaceboDrug
Placebo, 1 capsule
PlaceboDrug
Placebo, 1 capsule
PlaceboDrug
Placebo, 1 capsule
PlaceboDrug
Placebo, 2 capsules
PlaceboDrug
Placebo, 1 capsule
PlaceboDrug
Placebo, 2 capsules
| Study group | Role | What they receive |
|---|---|---|
| A dose as CJ-15314 or placebo | Experimental | Oral administration of A as CJ-15314 or placebo once a day Receives: Drug: A dose as CJ-15314; Drug: Placebo |
| B dose as CJ-15314 or placebo | Experimental | Oral administration of B as CJ-15314 or placebo once a day Receives: Drug: B dose as CJ-15314; Drug: Placebo |
| C dose as CJ-15314 or placebo | Experimental | Oral administration of C as CJ-15314 or placebo once a day and once daily for 7 days Receives: Drug: C dose as CJ-15314; Drug: Placebo |
| D dose as CJ-15314 or placebo | Experimental | Oral administration of D as CJ-15314 or placebo once a day and once daily for 7 days Receives: Drug: D dose as CJ-15314; Drug: Placebo |
| E dose as CJ-15314 or placebo | Experimental | Oral administration of E as CJ-15314 or placebo once a day and once daily for 7 days Receives: Drug: E dose as CJ-15314; Drug: Placebo |
| F dose as CJ-15314 or placebo | Experimental | Oral administration of F as CJ-15314 or placebo once a day and once daily for 7 days Receives: Drug: F dose as CJ-15314; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of single dose of CJ-15314
Measured: Up to 72 hours
Tmax of single dose of CJ-15314
Measured: Up to 72 hours
AUClast of single dose of CJ-15314
Measured: Up to 72 hours
AUCinf of single dose of CJ-15314
Measured: Up to 72 hours
t1/2 of single dose of CJ-15314
Measured: Up to 72 hours
λz of single dose of CJ-15314
Measured: Up to 72 hours
CL/F of single dose of CJ-15314
Measured: Up to 72 hours
Vd/F of single dose of CJ-15314
Measured: Up to 72 hours
Ae of single dose of CJ-15314
Measured: Up to 72 hours
fe of single dose of CJ-15314
Measured: Up to 72 hours
CLR of single dose of CJ-15314
Measured: Up to 72 hours
Cmax,ss of multiple doses of CJ-15314
Measured: Up to 72 hours
Cmin,ss of multiple doses of CJ-15314
Measured: Up to 72 hours
Cav,ss of multiple doses of CJ-15314
Measured: Up to 72 hours
Tmax,ss of multiple doses of CJ-15314
Measured: Up to 72 hours
AUCtau,ss of multiple doses of CJ-15314
Measured: Up to 72 hours
t1/2 of multiple doses of CJ-15314
Measured: Up to 72 hours
PTF of multiple doses of CJ-15314
Measured: Up to 72 hours
Ra of multiple doses of CJ-15314
Measured: Up to 72 hours
Ae of multiple doses of CJ-15314
Measured: Up to 72 hours
fe of multiple doses of CJ-15314
Measured: Up to 72 hours
CLR of multiple doses of CJ-15314
Measured: Up to 72 hours
Secondary outcomes (19)
Cmax of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Measured: Up to 72 hours
Tmax of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Measured: Up to 72 hours
AUClast of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Measured: Up to 72 hours
AUCinf of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Measured: Up to 72 hours
t1/2 of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Measured: Up to 72 hours
λz of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Measured: Up to 72 hours
Ae of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Measured: Up to 72 hours
fe of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Measured: Up to 72 hours
Metabolic ratio of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Measured: Up to 72 hours
Cmax,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Measured: Up to 72 hours
Cmin,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Measured: Up to 72 hours
Cav,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Measured: Up to 72 hours
Tmax,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Measured: Up to 72 hours
AUCtau,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Measured: Up to 72 hours
t1/2 of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Measured: Up to 72 hours
PTF of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Measured: Up to 72 hours
Ra of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Measured: Up to 72 hours
Ae of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Measured: Up to 72 hours
Metabolic ratio of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start24 Feb 2020
- Primary completionJan 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- In-Jin Jang, MD, PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297865
- Sponsor's protocol ID
- CJ_JSI_101
- Status last verified
- Mar 2020
- First submitted
- 21 Feb 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huh KY, Kang J, Jang H, Kang D, Jang IJ, Lee SH. Safety, pharmacodynamics and pharmacokinetics of a novel JAK1-selective inhibitor, IN-115314, in healthy participants: A first-in-human study. Br J Clin Pharmacol. 2026 Sep 28. doi: 10.1002/bcp.70847. Online ahead of print.
PubMed 42806494
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CJ-15314 Phosphate in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT04297865
- Acronym / sponsor ID
- CJ_JSI_101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 6 Mar 2020 (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 study aims to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of CJ-15314 phosphate in healthy male subjects.
Detailed description
- To evaluate the safety, tolerability and pharmacokinetics of single or multiple dose of CJ-15314 phosphate in healthy male subjects
- To explore the pharmacodynamics of single or multiple dose of CJ-15314 phosphate in healthy male subjects
- To explore the pharmacokinetics of CJ-15314 Phosphate active metabolites of single or multiple dose of CJ-15314 phosphate in healthy male subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A dose as CJ-15314 or placebo | Experimental | Drug: A dose as CJ-15314, Drug: PlaceboOral administration of A as CJ-15314 or placebo once a day |
| B dose as CJ-15314 or placebo | Experimental | Drug: B dose as CJ-15314, Drug: PlaceboOral administration of B as CJ-15314 or placebo once a day |
| C dose as CJ-15314 or placebo | Experimental | Drug: C dose as CJ-15314, Drug: PlaceboOral administration of C as CJ-15314 or placebo once a day and once daily for 7 days |
| D dose as CJ-15314 or placebo | Experimental | Drug: D dose as CJ-15314, Drug: PlaceboOral administration of D as CJ-15314 or placebo once a day and once daily for 7 days |
| E dose as CJ-15314 or placebo | Experimental | Drug: E dose as CJ-15314, Drug: PlaceboOral administration of E as CJ-15314 or placebo once a day and once daily for 7 days |
| F dose as CJ-15314 or placebo | Experimental | Drug: F dose as CJ-15314, Drug: PlaceboOral administration of F as CJ-15314 or placebo once a day and once daily for 7 days |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male adults aged 19 to 55 years (inclusive) at the time of signing the informed consent form.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m^2 with a body weight ≥ 50.0 kg and ≤ 90.0 kg at screening.
- ☞ BMI (kg/m^2) = weight (kg) / {height (m)}^2
- Decides to participate voluntarily in the study after being fully informed of and understanding the study completely, and provides his written informed consent prior to screening procedure.
- Determined eligible for this study in the opinion of the investigator based on the results of vital signs, physical examination, 12-lead electrocardiogram, clinical laboratory tests, and medical interview drug screening test.
Key exclusion criteria (22 listed)
- Has a history or current evidence of clinically significant disorder of hepatic, renal, nervous, respiratory, endocrine, hemato-oncologic, cardiovascular, urinary, and/or psychiatric system.
- Has a history or current evidence of gastrointestinal disease that may affect the safety and PD assessment of IP or a history of gastrointestinal surgery (except for simple appendectomy or herniotomy).
- Has rheumatoid arthritis or has a history.
- Has symptomatic herpes simplex or herpes zoster or has a history within 3 months prior to the scheduled first dose.
- Has live vaccine dose within 3 months prior to the scheduled first dose or expects to receive live vaccine during the clinical trial period.
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 |
|---|---|---|
| A dose as CJ-15314A dose as CJ-15314, 1 capsule | Drug | A dose as CJ-15314 or placebo |
| B dose as CJ-15314B dose as CJ-15314, 1 capsule | Drug | B dose as CJ-15314 or placebo |
| C dose as CJ-15314C dose as CJ-15314, 1 capsule | Drug | C dose as CJ-15314 or placebo |
| D dose as CJ-15314D dose as CJ-15314, 2 capsules | Drug | D dose as CJ-15314 or placebo |
| E dose as CJ-15314E dose as CJ-15314, 1 capsule | Drug | E dose as CJ-15314 or placebo |
| F dose as CJ-15314F dose as CJ-15314, 2 capsules | Drug | F dose as CJ-15314 or placebo |
| PlaceboPlacebo, 1 capsule | Drug | A dose as CJ-15314 or placebo |
| PlaceboPlacebo, 1 capsule | Drug | B dose as CJ-15314 or placebo |
| PlaceboPlacebo, 1 capsule | Drug | C dose as CJ-15314 or placebo |
| PlaceboPlacebo, 2 capsules | Drug | D dose as CJ-15314 or placebo |
| PlaceboPlacebo, 1 capsule | Drug | E dose as CJ-15314 or placebo |
| PlaceboPlacebo, 2 capsules | Drug | F dose as CJ-15314 or placebo |
Primary outcome
Cmax of single dose of CJ-15314
Time frame: Up to 72 hours
Tmax of single dose of CJ-15314
Time frame: Up to 72 hours
AUClast of single dose of CJ-15314
Time frame: Up to 72 hours
AUCinf of single dose of CJ-15314
Time frame: Up to 72 hours
t1/2 of single dose of CJ-15314
Time frame: Up to 72 hours
λz of single dose of CJ-15314
Time frame: Up to 72 hours
CL/F of single dose of CJ-15314
Time frame: Up to 72 hours
Vd/F of single dose of CJ-15314
Time frame: Up to 72 hours
Ae of single dose of CJ-15314
Time frame: Up to 72 hours
fe of single dose of CJ-15314
Time frame: Up to 72 hours
CLR of single dose of CJ-15314
Time frame: Up to 72 hours
Cmax,ss of multiple doses of CJ-15314
Time frame: Up to 72 hours
Cmin,ss of multiple doses of CJ-15314
Time frame: Up to 72 hours
Cav,ss of multiple doses of CJ-15314
Time frame: Up to 72 hours
Tmax,ss of multiple doses of CJ-15314
Time frame: Up to 72 hours
AUCtau,ss of multiple doses of CJ-15314
Time frame: Up to 72 hours
t1/2 of multiple doses of CJ-15314
Time frame: Up to 72 hours
PTF of multiple doses of CJ-15314
Time frame: Up to 72 hours
Ra of multiple doses of CJ-15314
Time frame: Up to 72 hours
Ae of multiple doses of CJ-15314
Time frame: Up to 72 hours
fe of multiple doses of CJ-15314
Time frame: Up to 72 hours
CLR of multiple doses of CJ-15314
Time frame: Up to 72 hours
19 secondary outcomes
Cmax of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time frame: Up to 72 hours
Tmax of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time frame: Up to 72 hours
AUClast of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time frame: Up to 72 hours
AUCinf of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time frame: Up to 72 hours
t1/2 of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time frame: Up to 72 hours
λz of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time frame: Up to 72 hours
Ae of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time frame: Up to 72 hours
fe of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time frame: Up to 72 hours
Metabolic ratio of CJ-16118 (major metabolite of CJ-15314) of single dose of CJ-15314
Time frame: Up to 72 hours
Cmax,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours
Cmin,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours
Cav,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours
Tmax,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours
AUCtau,ss of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours
t1/2 of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours
PTF of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours
Ra of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours
Ae of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours
Metabolic ratio of CJ-16118 (major metabolite of CJ-15314) of multiple doses of CJ-15314
Time frame: Up to 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Derived from this study: PubMed 42806494Huh KY, Kang J, Jang H, Kang D, Jang IJ, Lee SH. Safety, pharmacodynamics and pharmacokinetics of a novel JAK1-selective inhibitor, IN-115314, in healthy participants: A first-in-human study. Br J Clin Pharmacol. 2026 Sep 28. doi: 10.1002/bcp.70847. Online ahead of print.
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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.
In-Jin Jang, MD, PhD principal investigator
Study Principal Investigator
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 A dose as CJ-15314, B dose as CJ-15314 and C dose as CJ-15314 in people with Healthy, run by HK inno.N Corporation 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 5 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 6 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hukeun Lee, MS (+82-2-6477-0208, hukeun.lee@kolmar.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax of single dose of CJ-15314 (time frame: Up to 72 hours). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04297865, which also lists 1 linked publication.
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 6 Mar 2020.