SepsisPhase 1NCT04255979
A Study of HY209 in Healthy Male Volunteers for Sepsis
A Phase 1 study testing HY209 in people with Sepsis, run by Shaperon at 1 site in South Korea.
Trial summary
A randomized, double-blind, placebo-controlled single dosing, dose escalation phase I clinical trial to investigate the safety/tolerability and pharmacokinetics of HY209 after intravenous administration in healthy male volunteers 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
- Sepsis
- What is being tested?
- HY209
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Dec 2019to 12 Jun 2020
- 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
- Healthy male aged from 19 to 45 at screening test
- 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
Who cannot join
- Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs (containing Taurodeoxycholate component, aspirin, antibiotics, etc.)
- 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]
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Single Dosing, Dose Escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of HY209 After Intravenous Administration in Healthy Male Volunteers
A randomized, double-blind, placebo-controlled single dosing, dose escalation phase I clinical trial to investigate the safety/tolerability and pharmacokinetics of HY209 after intravenous administration in healthy male volunteers
Read the detailed description
HY209, which is being developed for the treatment of sepsis, inhibits inflammation by promoting the differentiation and division of Myeloid-derived suppressor cells (MDSCs).
- Conditions
- Sepsis
- Being tested
- HY209
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HY209Drug
Also called HY209-IV
6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Single dose of HY209 0.1 mg/kg or placebo. Receives: Drug: HY209 |
| Cohort 2 | Experimental | Single dose of HY209 0.2 mg/kg or placebo. Receives: Drug: HY209 |
| Cohort 3 | Experimental | Single dose of HY209 0.4 mg/kg or placebo. Receives: Drug: HY209 |
| Cohort 4 | Experimental | Single dose of HY209 0.8 mg/kg or placebo. Receives: Drug: HY209 |
| Cohort 5 | Experimental | Single dose of HY209 1.6 mg/kg or placebo. Receives: Drug: HY209 |
| Cohort 6 | Experimental | Single dose of HY209 3.2 mg/kg or placebo. Receives: Drug: HY209 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events (TEAEs)
Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment
Measured: Up to Day 6
Secondary outcomes (5)
Maximum concentration (Cmax) of HY209
Maximum concentration of HY209 in plasma
Measured: Up to Day 2
Ratio of area under curve infinity (AUCinf) of HY209
Area under the plasma HY209 concentration-time curve over the time interval from 0 extrapolated to infinity
Measured: Up to Day 2
Ratio of area under curve last (AUClast) of HY209
Area under the plasma HY209 concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration
Measured: Up to Day 2
Time of maximum concentration (Tmax) of HY209
Time of maximum concentration of HY209 in plasma
Measured: Up to Day 2
Terminal halif-life (t1/2) of HY209
Terminal half-life of HY209 in plasma
Measured: Up to Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start5 Dec 2019
- Primary completion12 Jun 2020
- Study completion12 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Model description
- Randomized, double-blind, placebo-controlled single dosing, dose escalation
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaperon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- In-jin Jang, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255979
- Sponsor's protocol ID
- HY209-IV
- Status last verified
- Nov 2020
- First submitted
- 3 Feb 2020
- Last updated
- 30 Nov 2020
- 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 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Single Dosing, Dose Escalation Phase I Clinical Trial to Investigate the Safety/Tolerability and Pharmacokinetics of HY209 After Intravenous Administration in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT04255979
- Acronym / sponsor ID
- HY209-IV
- Conditions
- Sepsis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ShaperonIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 12 Jun 2020 (actual)
- Study completion
- 12 Jun 2020 (actual)
- First posted
- 5 Feb 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.
A randomized, double-blind, placebo-controlled single dosing, dose escalation phase I clinical trial to investigate the safety/tolerability and pharmacokinetics of HY209 after intravenous administration in healthy male volunteers
Detailed description
HY209, which is being developed for the treatment of sepsis, inhibits inflammation by promoting the differentiation and division of Myeloid-derived suppressor cells (MDSCs).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Randomized, double-blind, placebo-controlled single dosing, dose escalation
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: HY209Single dose of HY209 0.1 mg/kg or placebo. |
| Cohort 2 | Experimental | Drug: HY209Single dose of HY209 0.2 mg/kg or placebo. |
| Cohort 3 | Experimental | Drug: HY209Single dose of HY209 0.4 mg/kg or placebo. |
| Cohort 4 | Experimental | Drug: HY209Single dose of HY209 0.8 mg/kg or placebo. |
| Cohort 5 | Experimental | Drug: HY209Single dose of HY209 1.6 mg/kg or placebo. |
| Cohort 6 | Experimental | Drug: HY209Single dose of HY209 3.2 mg/kg or placebo. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male aged from 19 to 45 at screening test
- 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
Key exclusion criteria (14 listed)
- Those who have a history of hypersensitivity or clinically significant hypersensitivity reactions to drugs (containing Taurodeoxycholate component, aspirin, antibiotics, etc.)
- 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
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 |
|---|---|---|
| HY209Also: HY209-IV6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
Incidence of treatment emergent adverse events (TEAEs)
Time frame: Up to Day 6
Number of subjects with abnormal laboratory values and/or adverse events that are related to treatment
5 secondary outcomes
Maximum concentration (Cmax) of HY209
Time frame: Up to Day 2
Ratio of area under curve infinity (AUCinf) of HY209
Time frame: Up to Day 2
Ratio of area under curve last (AUClast) of HY209
Time frame: Up to Day 2
Time of maximum concentration (Tmax) of HY209
Time frame: Up to Day 2
Terminal halif-life (t1/2) of HY209
Time frame: Up to Day 2
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 30 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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 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 HY209 in people with Sepsis, run by Shaperon 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 14 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 30 Nov 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?
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 (TEAEs) (time frame: Up to Day 6). 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 30 Nov 2020.