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 range

20 Years – 45 Years

Sex

MALE

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

20 Years – 45 Years

Sex

MALE

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)

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