DementiaPhase 1NCT06533878
Evaluate Tolerability and Safety of HY209 in Healthy Volunteers
A Phase 1 study testing HY-209 in people with Dementia, run by Kukjeon Pharmaceutical Co.,Ltd. at 1 site in South Korea.
Trial summary
Primary study objectives in Parts A and B To determine the Maximum Tolerable Dose(MTD) of the study drug (repeated or single dose). Endpoint: • Adverse event(AEs), including objective and subjective symptoms, after the IP dosing as well as physical examinations, vital signs, ECGs, and laboratory tests findings related… Read more about this study
- Who is it for?
- Ages 19 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- HY-209
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Sep 2023to 31 Dec 2025
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who have received a full explanation about the study and the characteristics of the investigational product (IP), understood them, and then have provided voluntary consent for the study participation and fulfillment of the subject obligations during the study
- Healthy adult males ≥ 19 years and ≤ 45 years of age at the time of screening
- Subjects with weight ≥ 55 kg and ≤ 90 kg and BMI ≥ 18.0 and < 30.0 kg/m²
- Subjects without congenital or chronic diseases and pathological symptoms or findings in the medical examinations
- Subjects determined eligible for the study participation based on the results from laboratory tests, including serology, hematology, blood chemistry, urinalysis, and urine drug screening, vital signs, physical examinations, and electrocardiography (ECG), performed depending on the drug characteristics at screening (subjects with physical examinations, laboratory tests and ECG findings beyond the normal range may be allowed to take part in the study when they do not have clinically significant diseases and obvious ground for participation can be provided in the investigator's opinion)
Who cannot join
- Clinically significant diseases or past history that precludes the study participation in the investigator's opinion
- Occurrence of any diseases (illnesses) within 1 week prior to start of the IP dosing [e.g., flu epidemic or common cold, fever ≥ 38℃]). (However, when the disease is resolved in a short period of time, their study participation can be determined through a follow-up test after treatment.)
- Unable or unwilling to take tablets
- The following diseases and health conditions that may affect the pharmacokinetics (PK) of the IP, including absorption
- Gastrointestinal (GI) diseases (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.)
- Past history of cholecystectomy, bariatric procedures and/or any GI surgery that may interfere with the PK profile of the study drug, except simple cholecystectomy or hernia surgery
Show all 40Show fewer
- Rare hereditary problems of galactose intolerance, the Lapp lactose deficiency, or glucose galactose malabsorption
- The following laboratory test results at screening (However, for liver tests, any test results that are considered to be caused by clinically meaningless transient changes or one-time alcohol consumption and night-shift work and other lifestyle can be finally confirmed through follow-up tests after the correction)
- Elevated alanine aminotransferase (ALT) > 1.1 x upper limit of normal (ULN)
- Elevated aspartate aminotransferase (AST) > 1.2 x ULN
- Elevated total bilirubin > 1.2 x ULN
- Elevated creatinine > 0.1 mg/dL from the ULN
- Estimated glomerular filtration rate(eGFR) < 60 mL/min/1.73 m²
- Systolic blood pressure (BP) ≥ 150 mmHg or ≤ 100 mmHg, or diastolic BP ≥ 100 mmHg or ≤ 60 mmHg in the vital signs as measured in a sitting position after taking a rest for at least 3 minutes
- Pulse rate < 50 beats/min (bpm) or > 90 bpm when measured in a sitting position after taking a rest for at least 3 minutes; or < 45 bpm when (1) a normal thyroid function is confirmed with interview, physical examinations, and Thyroid stimulating Hormone(TSH) tests and (2) there is no clinical symptom of bradycardia (orthostatic hypotension and vertigo).
- Patients with clinically significant arrhythmia in the ECGs in the investigator's opinion (not applicable for the first degree atrioventricular(AV) block associated with the heart rate that meet the inclusion criteria)
- Clinically significant findings in 12-lead ECGs at screening
- History of malignancy, except for the following cases
- At least 5 years have passed without recurrence after appropriate treatments
- Appropriately treated thyroid cancer (papillary, follicular, and medullary types of Stage I or II), skin basal cell or squamous cell carcinoma and lentigo maligna (malignant black spots), and intraepithelial carcinoma in other areas
- Patients with the following active infections:
- Tuberculosis (when confirmed with medical history, physical examinations, or radiological findings if needed, or Tuberculin(TB) test)
- Hepatitis B (perform hepatitis B surface(HBs) Ag only as screening; when confirmed positive in immunoglobulin M(IgM) anti-hepatitis B core antigen(HBc) and Hepatitis B virus(HBV) Nuclei acid test(NAT) tests)
- Hepatitis C (perform Anti-HCV only as screening; subjects with positive anti-HCV can take part in the study when negative result is confirmed in NAT for HCV RNA)
- HIV infection (Anti-HIV only for screening)
- Syphilis (perform venereal disease research laboratory(VDRL) or Rapid plasma reagin(RPR) as screening; patients with positive serology are not eligible)
- Persistent alcohol consumption within 6 months prior to the first dose (exceeding 21 units/week, 1 unit = 10 g = 12.5 mL of pure alcohol) or unable to abstain from consuming alcohol throughout the study period from 72 hours prior to the first dose of the study drug to the end of study (the final visit) [e.g., 1 cup (250 mL) of beer (5%) = 1 glass (50 mL) of 10 g soju (20%) = 1 glass (125 mL) of 8 g wine (12%) = 12 g]
- Smokers (subjects who quit smoking at least 6 months prior to screening and have negative urine cotinine test at screening or who have never smoked are eligible)
- Whole blood donation or loss of substantial amount of blood within 2 months or apheresis within 1 month, or blood transfusion within 1 month prior to the first dose
- Past history of hypersensitivity to any components of the IP
- Subjects who have received any of the following drugs prior to the study participation and the required washout period has not passed
- Prescription or over-the-counter drugs: Periodic treatment with any prescription or over-the-counter drugs (including Vitamins). Subjects should discontinue the drugs at least 14 days prior to the first dose of the study drug. Subjects who want to take part in the study should discontinue any prescribed drugs upon the physician's decision.
- Oriental medications, herbal products, and dietary supplements: Subjects should discontinue use of herbal products or dietary supplements [e.g., St. John's Wort, ginseng, ginkgo biloba, and garlic supplements)] at least 14 days prior to the first dose of the study drug.
- Special fruits: Intake of grapefruit or grapefruit juice, Seville oranges, or pomelos should be restricted from at least 14 days prior to the first dose of the study drug.
- History of substance or alcohol abuse or addiction within 2 years prior to the start of the study drug or positive screening results for alcohol, smoking, or abusive drugs [e.g., cotinine, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine or opioids, tricyclic antidepressants] at screening
- Males who do not agree to use effective contraceptions during the study period and up to 3 months after the last dose of the study drug
- Persons who do not agree to refrain from donating their sperms during the study period and at least 3 months after the last dose of the study drug
- Persons who answer "Yes" to any of the questions in the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 12 months at screening (for Part B only)
- Persons who are participating in another clinical study or have taken a drug in another clinical study or bioequivalence study within 6 months prior to the first dose of the study drug (however, to determine the end of other study participation, the next day of the last dose will be counted as Day 1.)
- Other cases that make the subject ineligible for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: (Part A) A Non-randomized, Open, Single-dose Escalation to Evaluate Tolerability and Safety of Single Oral Dose of HY209; (Part B) A Block-randomized, Double-blinded, Placebo-controlled, Multiple-dose Escalation to Evaluate Tolerability and Safety of Multiple Oral Doses of HY209 Phase 1 Clinical Trial in Healthy Volunteers
- Primary study objectives in Parts A and B To determine the Maximum Tolerable Dose(MTD) of the study drug (repeated or single dose).
- Endpoint: • Adverse event(AEs), including objective and subjective symptoms, after the IP dosing as well as physical examinations, vital signs, ECGs, and laboratory tests findings related to the IP dosing
- Dose-limiting toxicities (DLTs)
- Justification for endpoints: The safety will be assessed comprehensively by performing safety assessment and evaluating relevant variables by dose group.
The tolerability will be assessed in DLT analysis set. In a first-in-human clinical trial, tolerability of the drug administered is usually assessed through determination of dose-limiting toxicity (DLT). An accurate dose proportionality of toxicity was not observed, but toxicity was found at high doses, not at low doses following IV and oral administrations, except transdermal treatment. Thus, a relationship between toxicity and doses was confirmed.
Read more
In addition, HY209 showed a dose dependence in some efficacy endpoints, including dose-dependent inhibition of release of Tumor Necrosis Factor(TNF)-α and Il-1β, key inflammation factors related to inflammatory bowel disease. Thus, evaluating the occurrence of DLTs through sequential dose escalation is determined appropriate to assess the tolerability and safety of HY209.
- Primary study objectives in Part A (Dose levels 4-6): To evaluate the effects of food on HY209 bioavailability (absorption rate and volume) following a single oral dose in healthy volunteers.
- Endpoint: PK of HY209 at a fasting condition and after a high-fat meal Point estimates for the geometric mean ratio of variables (Area under concentration-time curve;AUC₀-₆, AUCₗₐₛₜ, AUC₀-∞, and Cmax) and the 90% confidence interval(CI) and Tmax .
- Justification for endpoints: For oral drugs, effects of food on bioavailability of the drugs are usually evaluated. Especially, a systemic exposure to bile acid drugs of enterohepatic circulation can be explained with a spillover from the liver to systemic circulatory system. Thus, a systemic exposure is thought to be affected by food, but the actual effects of food are triggered by combination of factors that affect in vivo elution of a drug and absorption of the active pharmaceutical ingredient(API) of the drug. As estimating the extent of effects on bioavailability is difficult without conducting an actual food effect study, there is a need for clinical evaluation.
- Conditions
- Dementia
- Being tested
- HY-209, HY-209 placebo
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HY-209Drug
Enteric coated tablet in the following colors: pink for 100 mg and yellow for 50 mg, and white for 10 mg
HY-209 placeboDrug
Enteric coated tablet in the following colors: pink for 100 mg and yellow for 50 mg
| Study group | Role | What they receive |
|---|---|---|
| Part A Dose Level 1 | Other | HY209 10 mg (1 tablet; 10 mg qd) fed, morning Receives: Drug: HY-209 |
| Part A Dose Level 2 | Other | HY209 50 mg (1 tablet; 50 mg qd) fed, morning Receives: Drug: HY-209 |
| Part A Dose Level 3 | Other | 1. HY209 100 mg (1 tablet; 100 mg qd) fed, morning
2. HY209 100 mg (2 tablets; 50 mg bid) fed, morning, evening Receives: Drug: HY-209 |
| Part A Dose Level 4 | Other | 1. HY209 200 mg (2 tablets; 200 mg qd) fasting, morning
2. HY209 200 mg (2 tablets; 200 mg qd) fed, morning Receives: Drug: HY-209 |
| Part A Dose Level 5 | Other | 1. HY209 300 mg (3 tablets; 300 mg qd) fasting, morning
2. HY209 300 mg (3 tablets; 300 mg qd) fed, morning Receives: Drug: HY-209 |
| Part A Dose Level 6 | Other | 1. HY209 400 mg (4 tablets; 400 mg qd) fasting, morning
2. HY209 400 mg (4 tablets; 400 mg qd) fed, morning Receives: Drug: HY-209 |
| Part B Dose Level 1 | Placebo comparator | 1. HY209 150 mg (3 tablets; 50 mg tid) fed, morning, afternoon, evening
2. HY209 placebo fed, morning, afternoon, evening Receives: Drug: HY-209; Drug: HY-209 placebo |
| Part B Dose Level 2 | Placebo comparator | 1. HY209 200 mg (2 tablets; 200 mg qd) fed, morning
2. HY209 placebo fed, morning Receives: Drug: HY-209; Drug: HY-209 placebo |
| Part B Dose Level 3 | Placebo comparator | 1. HY209 200 mg (2 tablets; 100 mg bid) fed, morning, evening
2. HY209 placebo fed, morning, evening Receives: Drug: HY-209; Drug: HY-209 placebo |
| Part B Dose Level 4 | Placebo comparator | 1. HY209 300 mg (3 tablets; 100 mg tid) fed, morning, afternoon, evening
2. HY209 placebo fed, morning, afternoon, evening Receives: Drug: HY-209; Drug: HY-209 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, physical examinations, vital signs, ECGs, laboratory tests findings related to the IP dosing, Does limiting toxicity, PK assessment endpoints
Part A
- AEs, including objective and subjective symptoms, after the IP dosing as well as physical examinations, vital signs, ECGs, and laboratory tests findings related to the IP dosing
- [Part A: Phase 1a or Phase 1 dose escalation] incidence and frequency of DLTs observed until 7 days after HY209 treatment for each dose and dosage cohort
- [Part A (Dose levels 4-6): effects of food on bioavailability] point estimates of geometric mean ratio for PK parameters (AUC₀-₆, AUCₗₐₛₜ, AUC₀-∞, and Cmax) following a single dose at a fasting condition and after a high-fat meal and the 90% CI and Tmax
Part B
- AEs, including objective and subjective symptoms, after the IP dosing as well as physical examinations, vital signs, ECGs, and laboratory tests findings related to the IP dosing
- [Part B: Phase 1b or Phase 1 cohort expansion] incidence and frequency of DLTs observed until 7 days after the last dose of HY209 for each dose and dosage cohort
Measured: Test of DLTs observed until 7 days after the last does of HY209 for each dose and dosage cohort.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start13 Sep 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kukjeon Pharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533878
- Sponsor's protocol ID
- HY209-Tab01
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (Part A) A Non-randomized, Open, Single-dose Escalation to Evaluate Tolerability and Safety of Single Oral Dose of HY209; (Part B) A Block-randomized, Double-blinded, Placebo-controlled, Multiple-dose Escalation to Evaluate Tolerability and Safety of Multiple Oral Doses of HY209 Phase 1 Clinical Trial in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT06533878
- Acronym / sponsor ID
- HY209-Tab01
- Conditions
- Dementia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Kukjeon Pharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Aug 2024 (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.
- Primary study objectives in Parts A and B To determine the Maximum Tolerable Dose(MTD) of the study drug (repeated or single dose).
- Endpoint: • Adverse event(AEs), including objective and subjective symptoms, after the IP dosing as well as physical examinations, vital signs, ECGs, and laboratory tests findings related to the IP dosing
- Dose-limiting toxicities (DLTs)
- Justification for endpoints: The safety will be assessed comprehensively by performing safety assessment and evaluating relevant variables by dose group.
The tolerability will be assessed in DLT analysis set. In a first-in-human clinical trial, tolerability of the drug administered is usually assessed through determination of dose-limiting toxicity (DLT). An accurate dose proportionality of toxicity was not observed, but toxicity was found at high doses, not at low doses following IV and oral administrations, except transdermal treatment. Thus, a relationship between toxicity and doses was confirmed.
In addition, HY209 showed a dose dependence in some efficacy endpoints, including dose-dependent inhibition of release of Tumor Necrosis Factor(TNF)-α and Il-1β, key inflammation factors related to inflammatory bowel disease. Thus, evaluating the occurrence of DLTs through sequential dose escalation is determined appropriate to assess the tolerability and safety of HY209.
- Primary study objectives in Part A (Dose levels 4-6): To evaluate the effects of food on HY209 bioavailability (absorption rate and volume) following a single oral dose in healthy volunteers.
- Endpoint: PK of HY209 at a fasting condition and after a high-fat meal Point estimates for the geometric mean ratio of variables (Area under concentration-time curve;AUC₀-₆, AUCₗₐₛₜ, AUC₀-∞, and Cmax) and the 90% confidence interval(CI) and Tmax .
- Justification for endpoints: For oral drugs, effects of food on bioavailability of the drugs are usually evaluated. Especially, a systemic exposure to bile acid drugs of enterohepatic circulation can be explained with a spillover from the liver to systemic circulatory system. Thus, a systemic exposure is thought to be affected by food, but the actual effects of food are triggered by combination of factors that affect in vivo elution of a drug and absorption of the active pharmaceutical ingredient(API) of the drug. As estimating the extent of effects on bioavailability is difficult without conducting an actual food effect study, there is a need for clinical evaluation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Part A Dose Level 1 | Other | Drug: HY-209HY209 10 mg (1 tablet; 10 mg qd) fed, morning |
| Part A Dose Level 2 | Other | Drug: HY-209HY209 50 mg (1 tablet; 50 mg qd) fed, morning |
| Part A Dose Level 3 | Other | Drug: HY-2091. HY209 100 mg (1 tablet; 100 mg qd) fed, morning 2. HY209 100 mg (2 tablets; 50 mg bid) fed, morning, evening |
| Part A Dose Level 4 | Other | Drug: HY-2091. HY209 200 mg (2 tablets; 200 mg qd) fasting, morning 2. HY209 200 mg (2 tablets; 200 mg qd) fed, morning |
| Part A Dose Level 5 | Other | Drug: HY-2091. HY209 300 mg (3 tablets; 300 mg qd) fasting, morning 2. HY209 300 mg (3 tablets; 300 mg qd) fed, morning |
| Part A Dose Level 6 | Other | Drug: HY-2091. HY209 400 mg (4 tablets; 400 mg qd) fasting, morning 2. HY209 400 mg (4 tablets; 400 mg qd) fed, morning |
| Part B Dose Level 1 | Placebo comparator | Drug: HY-209, Drug: HY-209 placebo1. HY209 150 mg (3 tablets; 50 mg tid) fed, morning, afternoon, evening 2. HY209 placebo fed, morning, afternoon, evening |
| Part B Dose Level 2 | Placebo comparator | Drug: HY-209, Drug: HY-209 placebo1. HY209 200 mg (2 tablets; 200 mg qd) fed, morning 2. HY209 placebo fed, morning |
| Part B Dose Level 3 | Placebo comparator | Drug: HY-209, Drug: HY-209 placebo1. HY209 200 mg (2 tablets; 100 mg bid) fed, morning, evening 2. HY209 placebo fed, morning, evening |
| Part B Dose Level 4 | Placebo comparator | Drug: HY-209, Drug: HY-209 placebo1. HY209 300 mg (3 tablets; 100 mg tid) fed, morning, afternoon, evening 2. HY209 placebo fed, morning, afternoon, evening |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects who have received a full explanation about the study and the characteristics of the investigational product (IP), understood them, and then have provided voluntary consent for the study participation and fulfillment of the subject obligations during the study
- Healthy adult males ≥ 19 years and ≤ 45 years of age at the time of screening
- Subjects with weight ≥ 55 kg and ≤ 90 kg and BMI ≥ 18.0 and < 30.0 kg/m²
- Subjects without congenital or chronic diseases and pathological symptoms or findings in the medical examinations
- Subjects determined eligible for the study participation based on the results from laboratory tests, including serology, hematology, blood chemistry, urinalysis, and urine drug screening, vital signs, physical examinations, and electrocardiography (ECG), performed depending on the drug characteristics at screening (subjects with physical examinations, laboratory tests and ECG findings beyond the normal range may be allowed to take part in the study when they do not have clinically significant diseases and obvious ground for participation can be provided in the investigator's opinion)
Key exclusion criteria (40 listed)
- Clinically significant diseases or past history that precludes the study participation in the investigator's opinion
- Occurrence of any diseases (illnesses) within 1 week prior to start of the IP dosing [e.g., flu epidemic or common cold, fever ≥ 38℃]). (However, when the disease is resolved in a short period of time, their study participation can be determined through a follow-up test after treatment.)
- Unable or unwilling to take tablets
- The following diseases and health conditions that may affect the pharmacokinetics (PK) of the IP, including absorption
- Rare hereditary problems of galactose intolerance, the Lapp lactose deficiency, or glucose galactose malabsorption
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 |
|---|---|---|
| HY-209Enteric coated tablet in the following colors: pink for 100 mg and yellow for 50 mg, and white for 10 mg | Drug | Part A Dose Level 1, Part A Dose Level 2, Part A Dose Level 3, Part A Dose Level 4, Part A Dose Level 5, Part A Dose Level 6, Part B Dose Level 1, Part B Dose Level 2, Part B Dose Level 3, Part B Dose Level 4 |
| HY-209 placeboEnteric coated tablet in the following colors: pink for 100 mg and yellow for 50 mg | Drug | Part B Dose Level 1, Part B Dose Level 2, Part B Dose Level 3, Part B Dose Level 4 |
Primary outcome
Adverse events, physical examinations, vital signs, ECGs, laboratory tests findings related to the IP dosing, Does limiting toxicity, PK assessment endpoints
Time frame: Test of DLTs observed until 7 days after the last does of HY209 for each dose and dosage cohort.
Part A * AEs, including objective and subjective symptoms, after the IP dosing as well as physical examinations, vital signs, ECGs, and laboratory tests findings related to the IP dosing * [Part A: Phase 1a or Phase 1 dose escalation] incidence and frequency of DLTs observed until 7 days after HY209 treatment for each dose and dosage cohort * [Part A (Dose levels 4-6): effects of food on bioavailability] point estimates of geometric mean ratio for PK parameters (AUC₀-₆, AUCₗₐₛₜ, AUC₀-∞, and Cmax) following a single dose at a fasting condition and after a high-fat meal and the 90% CI and Tmax Part B * AEs, including objective and subjective symptoms, after the IP dosing as well as physical examinations, vital signs, ECGs, and laboratory tests findings related to the IP dosing * [Part B: Phase 1b or Phase 1 cohort expansion] incidence and frequency of DLTs observed until 7 days after the last dose of HY209 for each dose and dosage cohort
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Kawamata Y, Fujii R, Hosoya M, Harada M, Yoshida H, Miwa M, et al. A G protein-coupled receptor responsive to bile acids. J Biol Chem \[Internet\] 2003 \[cited 2021 May 10\];278(11):9435-40.Link provided by the sponsor.
- Zhong M. TGR5 as a Therapeutic Target for Treating Obesity. Curr Top Med Chem \[Internet\] 2010 \[cited 2021 May 10\];10(4):386-96.Link provided by the sponsor.
- Chang S, Kim YH, Kim YJ, Kim YW, Moon S, Lee YY, et al. Taurodeoxycholate increases the number of myeloid-derived suppressor cells that ameliorate sepsis in mice. Front Immunol \[Internet\] 2018 \[cited 2021 May 20\];9(SEP):1984.Link provided by the sponsor.
- Kawamata Y, Fujii R, Hosoya M, Harada M, Yoshida H, Miwa M, et al. A G protein-coupled receptor responsive to bile acids. J Biol Chem \[Internet\] 2003 \[cited 2021 May 26\];278(11):9435-40.Link provided by the sponsor.
- Kim H, Fang S. Crosstalk between FXR and TGR5 controls glucagon-like peptide 1 secretion to maintain glycemic homeostasis. Lab Anim Res \[Internet\] 2018 \[cited 2021 May 26\];34(4):140.Link provided by the sponsor.
- Altman DG, Bland JM. Statistics notes. Treatment allocation in controlled trials: why randomise? BMJ \[Internet\] 1999 \[cited 2016 Aug 30\];318(7192):1209.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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 HY-209 in people with Dementia, run by Kukjeon Pharmaceutical Co.,Ltd. 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 40 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 15 Aug 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?
Results are not available in the source record.
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?
Adverse events, physical examinations, vital signs, ECGs, laboratory tests findings related to the IP dosing, Does limiting toxicity, PK assessment endpoints (time frame: Test of DLTs observed until 7 days after the last does of HY209 for each dose and dosage cohort.). 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 15 Aug 2024.