Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2019-12-05
2020-06-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1
Single dose of HY209 0.1 mg/kg or placebo.
HY209
6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Cohort 2
Single dose of HY209 0.2 mg/kg or placebo.
HY209
6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Cohort 3
Single dose of HY209 0.4 mg/kg or placebo.
HY209
6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Cohort 4
Single dose of HY209 0.8 mg/kg or placebo.
HY209
6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Cohort 5
Single dose of HY209 1.6 mg/kg or placebo.
HY209
6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Cohort 6
Single dose of HY209 3.2 mg/kg or placebo.
HY209
6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HY209
6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI 18 kg/m2 \~ 27 kg/m2 at screening test
* Subjects found to be clinically healthy by medical history, physical examination, vital signs, electrocardiogram (ECG), and appropriate laboratory tests
* Those who must be capable of giving informed consent and willing to comply with all clinic visits and study-related procedures for the duration of study until study completion
Exclusion Criteria
* Those who showed clinical symptoms suspected of acute infectious disease within 2 weeks before the first does, or whose body temperature (ear canal) measured at screening showed 38 ℃ or higher
* Those who have a clinically significant disease of liver, kidney, digestive, respiratory, endocrine, neurologic, blood/tumor, cardiovascular system history of those diseases
* Those who have a history of gastrointestinal diseases or surgery that may affect the absorption of the investigational drug
* Those who have a history of substance abuse or have tested positive for drugs of concern for misuse by urine drug screening
* Patients with the following blood pressure measured at the seat after resting for more than 5 minutes at the screening visit \[Systolic blood pressure (SBP): \< 90 mmHg or \> 150 mmHg, Diastolic blood pressure (DBP): \< 50 mmHg or \> 90 mmHg\]
* Those who participated in other clinical trials or bioequivalence within 6 months prior to the first dosing and received the drug
* Those who have donated whole blood within 2 months before the first dose or ingredient donation within 1 month or received blood transfusion within 1 month
* Those who have taken metabolic enzyme-induced and inhibitory drugs within 1 month before screening
* Those who consumed grapefruit / caffeine-containing foods within 3 days of the first dose and who cannot refrain from eating grapefruit-containing foods from 3 days before admission to discharge date
* Those who have taken specialty or herbal medicines within 2 weeks of the first dose or who have taken over-the-counter (OTC) within 1 week
* Caffeine overdose, alcohol overdose or oversmoker
* Those who have unusual eating habits or who are unable to eat the meals provided in this clinical trial
* Other investigator judged to be unsuitable as clinical subject
19 Years
45 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shaperon
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
In-jin Jang
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HY209-IV
Identifier Type: -
Identifier Source: org_study_id