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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03896594 |
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Date of registration:
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28/03/2019 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Multiple Dose of HL237 in Healthy Male Subject
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Scientific title:
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A Dose Block-randomized, Double-blind, Placebo Controlled, Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics After Multiple Oral Dose of HL237 in Healthy Male Subject |
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Date of first enrolment:
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December 24, 2018 |
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Target sample size:
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36 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03896594 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Seunghun Han |
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Address:
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Telephone:
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82-2-2258-7326 |
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Email:
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waystolove@catholic.ac.kr |
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Affiliation:
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Name:
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Seunghun Han |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- A healthy adult male aged 20 years or older and 45 years old at the time of the
screening test
- Those who weigh more than 55kg but weigh less than ± 20% of ideal body weight
- Proper contraception during the clinical trial period
- After hearing the detailed explanation of the clinical trial, those who decide to
participate voluntarily and write agreement
Exclusion Criteria:
- Clinically significant, a person with a history of neurological, psychiatric,
malignant, cardiovascular, respiratory, kidney, endocrine, hematologic, digestive or
central disease
- a person with a history of gastrointestinal disorders that may affect the absorption
of pharmaceuticals for clinical trials (Crohn's disease, ulcers, etc.) or
gastrointestinal surgery (except for simple cecal surgery or hernia surgery)
- a person with a history of hypersensitivity or clinically significant hypersensitivity
to the clinical trial drug or additives
- a person judged to be inappropriate for the subject by health screening (history of
disease, physical examination, vital signs, electrocardiogram, laboratory test, etc.)
Age minimum:
20 Years
Age maximum:
45 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Placebo Oral Tablet
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Drug: HL237
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Primary Outcome(s)
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Half life [t1/2]
[Time Frame: 14days after administration]
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Area Under the Curve [AUC]
[Time Frame: 14days after administration]
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Maximum Plasma Concentration [Cmax]
[Time Frame: 14days after administration]
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Secondary Outcome(s)
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Number of participants with treatment-related adverse events
[Time Frame: 14days after administration]
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Secondary ID(s)
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HL237-102
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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