A Multiple Dose of HL237 in Healthy Male Subject

Sponsor

Hanlim Pharm. Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03896594

Collaborator

(none)

Enrollment

Location

Arms

9.2

Anticipated Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: HL237 Drug: Placebo Oral Tablet	Phase 1

Detailed Description

Doses are increased sequentially from low-capacity groups, and within six weeks after the last dose of the last subject in the ongoing dose phase, if available pharmacokinetic data are judged acceptable under review by investigators, sponsor and safety review committees, then proceed to the next dose stage.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Dec 24, 2018

Anticipated Primary Completion Date :

Jun 30, 2019

Anticipated Study Completion Date :

Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HL237 200mg HL237 100mg 1 tablet twice a day	Drug: HL237 Experimental Drug: Placebo Oral Tablet placebo with same properties except for active ingredient
Experimental: HL237 400mg HL237 100mg 2 tablets twice a day	Drug: HL237 Experimental Drug: Placebo Oral Tablet placebo with same properties except for active ingredient
Experimental: HL237 800mg HL237 400mg 1 tablet twice a day	Drug: HL237 Experimental Drug: Placebo Oral Tablet placebo with same properties except for active ingredient

Arm

Intervention/Treatment

Experimental: HL237 200mg

HL237 100mg 1 tablet twice a day

Drug: HL237

Experimental

Drug: Placebo Oral Tablet

placebo with same properties except for active ingredient

Experimental: HL237 400mg

HL237 100mg 2 tablets twice a day

Drug: HL237

Experimental

Drug: Placebo Oral Tablet

placebo with same properties except for active ingredient

Experimental: HL237 800mg

HL237 400mg 1 tablet twice a day

Drug: HL237

Experimental

Drug: Placebo Oral Tablet

placebo with same properties except for active ingredient

Outcome Measures

Primary Outcome Measures

Maximum Plasma Concentration [Cmax] [14days after administration]
maximum serum concentration after the drug has been administrated
Area Under the Curve [AUC] [14days after administration]
AUC after the drug has been administrated
Half life [t1/2] [14days after administration]
Half life after the drug has been administrated

Secondary Outcome Measures

Number of participants with treatment-related adverse events [14days after administration]
Adverse Adverse Events, Serious Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Catholic University of Korea, Seoul ST. Mary's Hospital	Seoul	Seocho-gu	Korea, Republic of	06591

Sponsors and Collaborators

Hanlim Pharm. Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanlim Pharm. Co., Ltd.

ClinicalTrials.gov Identifier:

NCT03896594

Other Study ID Numbers:

HL237-102

First Posted:

Apr 1, 2019

Last Update Posted:

Apr 2, 2019

Last Verified:

Mar 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Study Results

No Results Posted as of Apr 2, 2019