CompletedPhase 1

A Dose-Block Randomized, Placebo Controlled (Double-blind), Active Controlled(Open-label), Dose-escalation Study

South Korea58 participantsStarted 2014-05

Plain-language summary

The study design of this trial is a Dose-Block Randomized, Placebo controlled (Double-blind), Active Controlled(Open-label), Dose-escalation.

Who can participate

Age range20 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. A healthy adult man aged between 20 and 45 years (inclusive) at screening
✓. Weight between 55 and 90 kg (inclusive) and the body mass index(BMI) between 18.0 and 27.0 (inclusive)
✓. Voluntary consent to participation in this study and signature on the IRB-approved informed consent form after being explained about characteristics of this clinical study, prior to any screening test

Exclusion criteria

✕. Current or history of a clinically significant hepatic, renal, neurological, immunological, respiratory or endocrine disease or hematological or oncological disease, cardiovascular disease or psychiatric disease (mood disorder or compulsive disorder, etc.) (in case of a hepatic disease, a hepatitis virus-infected subject may be also included)
✕. Hypersensitivity to a drug (aspirin or antibiotics, etc.) or past history of clinically significant hypersensitivity
✕. In sitting vital signs measured after resting for 3 min or more, systolic blood pressure of \<90mmHg or \>150mmHg, or diastolic blood pressure of \<60mmHg or \>100 mmHg
✕. Past history of drug abuse or positive urine drug screening results
✕. Use of any prescription medicine or oriental medicine within 2 weeks or use of any over-the-counter(OTC) medication or vitamin preparation within 1 week prior to the scheduled first dose (however, a subject may be included if other conditions are satisfied, at the discretion of the investigator)
✕. Participation in another clinical study and administration of a drug within 3 months prior to the scheduled first dose (from the dosing day)
✕. Whole blood donation within 2 months or apheresis within 1 month prior to the scheduled first dose, or transfusion within 1 month prior to the first dose
✕. A habitual drinker (\>21 units/week, 1 unit = 10 g of pure alcohol) or a person who cannot abstain from alcohol consumption during hospitalization

What they're measuring

Tolerability as measured by the occurrence of Adverse Events

Timeframe: 29 days

Tolerability as measured by Physical Examination, Vital Signs and Safety Laboratory Tests

Timeframe: 29 days

Tolerability as measured by the occurrence of Local Toxicity

Timeframe: 4 days

Tolerability as measured by Cytokine Laboratory Test

Timeframe: 4 days

Pharmacokinetics of HL2351: Maximum plasma concentration(Cmax)

Timeframe: 29 days

Pharmacokinetics of HL2351: Area under plasma drug concentration-time curve [AUC(0-last), AUCinf]

Timeframe: 29 days

Pharmacokinetics of HL2351: Time of maximum concentration(Tmax)

Timeframe: 29 days

Pharmacokinetics of HL2351: Elimination half-life(T1/2)

Timeframe: 29 days

Trial details

NCT IDNCT02175056

SponsorHandok Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-01

View on ClinicalTrials.gov More Healthy Volunteers trials

Who can participate

Age range20 Years – 45 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. A healthy adult man aged between 20 and 45 years (inclusive) at screening
✓. Weight between 55 and 90 kg (inclusive) and the body mass index(BMI) between 18.0 and 27.0 (inclusive)
✓. Voluntary consent to participation in this study and signature on the IRB-approved informed consent form after being explained about characteristics of this clinical study, prior to any screening test

Exclusion criteria

✕. Current or history of a clinically significant hepatic, renal, neurological, immunological, respiratory or endocrine disease or hematological or oncological disease, cardiovascular disease or psychiatric disease (mood disorder or compulsive disorder, etc.) (in case of a hepatic disease, a hepatitis virus-infected subject may be also included)
✕. Hypersensitivity to a drug (aspirin or antibiotics, etc.) or past history of clinically significant hypersensitivity
✕. In sitting vital signs measured after resting for 3 min or more, systolic blood pressure of \<90mmHg or \>150mmHg, or diastolic blood pressure of \<60mmHg or \>100 mmHg
✕. Past history of drug abuse or positive urine drug screening results
✕. Use of any prescription medicine or oriental medicine within 2 weeks or use of any over-the-counter(OTC) medication or vitamin preparation within 1 week prior to the scheduled first dose (however, a subject may be included if other conditions are satisfied, at the discretion of the investigator)
✕. Participation in another clinical study and administration of a drug within 3 months prior to the scheduled first dose (from the dosing day)
✕. Whole blood donation within 2 months or apheresis within 1 month prior to the scheduled first dose, or transfusion within 1 month prior to the first dose
✕. A habitual drinker (\>21 units/week, 1 unit = 10 g of pure alcohol) or a person who cannot abstain from alcohol consumption during hospitalization

What they're measuring

Tolerability as measured by the occurrence of Adverse Events

Timeframe: 29 days

Tolerability as measured by Physical Examination, Vital Signs and Safety Laboratory Tests

Timeframe: 29 days

Tolerability as measured by the occurrence of Local Toxicity

Timeframe: 4 days

Tolerability as measured by Cytokine Laboratory Test

Timeframe: 4 days

Pharmacokinetics of HL2351: Maximum plasma concentration(Cmax)

Timeframe: 29 days

Pharmacokinetics of HL2351: Area under plasma drug concentration-time curve [AUC(0-last), AUCinf]

Timeframe: 29 days

Pharmacokinetics of HL2351: Time of maximum concentration(Tmax)

Timeframe: 29 days

Pharmacokinetics of HL2351: Elimination half-life(T1/2)

Timeframe: 29 days