A Multiple Dose of HL237 in Healthy Male Subject
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
1 other identifier
interventional
36
1 country
1
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 demonstrated in animal model. HL237 is a STAT3 inhibitor and STAT3 is well known for an important regulator inhibiting Th17 cells and activating Treg cells. Therefore, when STAT3 activity is inhibited, it is expected to be able to treat autoimmune diseases such as rheumatoid arthritis. This is the first repeated administration clinical trial performed for the development of HL237 and is intended to evaluate the safety, tolerability and pharmacokinetics of each dose group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 rheumatoid-arthritis
Started Dec 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 24, 2018
CompletedFirst Submitted
Initial submission to the registry
March 28, 2019
CompletedFirst Posted
Study publicly available on registry
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2019
CompletedApril 2, 2019
March 1, 2019
6 months
March 28, 2019
March 31, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
Maximum Plasma Concentration [Cmax]
maximum serum concentration after the drug has been administrated
14days after administration
Area Under the Curve [AUC]
AUC after the drug has been administrated
14days after administration
Half life [t1/2]
Half life after the drug has been administrated
14days after administration
Secondary Outcomes (1)
Number of participants with treatment-related adverse events
14days after administration
Study Arms (3)
HL237 200mg
EXPERIMENTALHL237 100mg 1 tablet twice a day
HL237 400mg
EXPERIMENTALHL237 100mg 2 tablets twice a day
HL237 800mg
EXPERIMENTALHL237 400mg 1 tablet twice a day
Interventions
placebo with same properties except for active ingredient
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, Seocho-gu, 06591, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2019
First Posted
April 1, 2019
Study Start
December 24, 2018
Primary Completion
June 30, 2019
Study Completion
September 30, 2019
Last Updated
April 2, 2019
Record last verified: 2019-03