A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject

A Dose Block-randomized, Double Blinded, Placebo Controlled, Dose-escalation Clinical Trial to Find the Maximum Tolerable Dose After Single Oral Dose of HL237 in Healthy Male Subject

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 clinical trial to be conducted for the development of HL237 and this clinical trial is for determining the maximum oral dose of HL237 and assessing safety, tolerability, and pharmacokinetic characteristics for each dose group.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: HL237; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Soeul, Korea, Republic of
    • The Catholic University of Korea Seoul St. Mary'S Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HL237 50mg; take oral tablet once	Drug: HL237; Experimental; Drug: Placebo Oral Tablet; placebo with same properties except for active ingredient
Experimental: HL237 100mg; take oral tablet once	Drug: HL237; Experimental; Drug: Placebo Oral Tablet; placebo with same properties except for active ingredient
Experimental: HL237 200mg; take oral tablet once	Drug: HL237; Experimental; Drug: Placebo Oral Tablet; placebo with same properties except for active ingredient
Experimental: HL237 400mg; take oral tablet once	Drug: HL237; Experimental; Drug: Placebo Oral Tablet; placebo with same properties except for active ingredient
Experimental: HL237 800mg; take oral tablet once	Drug: HL237; Experimental; Drug: Placebo Oral Tablet; placebo with same properties except for active ingredient
Experimental: HL237 1200mg; take oral tablet once	Drug: HL237; Experimental; Drug: Placebo Oral Tablet; placebo with same properties except for active ingredient
Experimental: HL237 1600mg; take oral tablet once	Drug: HL237; Experimental; Drug: Placebo Oral Tablet; placebo with same properties except for active ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration [Cmax]	maximum serum concentration after the drug has been administrated	3days after administration
Area Under the Curve [AUC]		3days after administration
half life [t1/2]		3days after administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-related adverse events	14days after administration

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2017
• Primary Completion (Actual): March 19, 2018
• Study Completion (Actual): March 19, 2018

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (Actual): September 11, 2017

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: HL-237-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No