Status:
COMPLETED
A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject
Lead Sponsor:
Hanlim Pharm. Co., Ltd.
Conditions:
Rheumatoid Arthritis
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
HL237 is a new autoimmune therapeutic agent for rheumatoid arthritis, including the basic structure of biguanide in metformin, an existing diabetes drug. The immune modulating activity of HL237 was d...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
June 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2018
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03278470
Start Date
June 26 2017
End Date
March 19 2018
Last Update
August 17 2018
Active Locations (1)
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1
The catholic university of korea seoul ST. mary's hospital
Soeul, South Korea