NCT03278470

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2018

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

9 months

First QC Date

September 7, 2017

Last Update Submit

August 16, 2018

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Number of participants with treatment-related adverse events

    14days after administration

Study Arms (7)

HL237 50mg

EXPERIMENTAL

take oral tablet once

Drug: HL237Drug: Placebo Oral Tablet

HL237 100mg

EXPERIMENTAL

take oral tablet once

Drug: HL237Drug: Placebo Oral Tablet

HL237 200mg

EXPERIMENTAL

take oral tablet once

Drug: HL237Drug: Placebo Oral Tablet

HL237 400mg

EXPERIMENTAL

take oral tablet once

Drug: HL237Drug: Placebo Oral Tablet

HL237 800mg

EXPERIMENTAL

take oral tablet once

Drug: HL237Drug: Placebo Oral Tablet

HL237 1200mg

EXPERIMENTAL

take oral tablet once

Drug: HL237Drug: Placebo Oral Tablet

HL237 1600mg

EXPERIMENTAL

take oral tablet once

Drug: HL237Drug: Placebo Oral Tablet

Interventions

HL237DRUG

Experimental

HL237 100mgHL237 1200mgHL237 1600mgHL237 200mgHL237 400mgHL237 50mgHL237 800mg
Placebo Oral TabletDRUG

placebo with same properties except for active ingredient

HL237 100mgHL237 1200mgHL237 1600mgHL237 200mgHL237 400mgHL237 50mgHL237 800mg

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Soeul, South Korea

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

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

September 7, 2017

First Posted

September 11, 2017

Study Start

June 26, 2017

Primary Completion

March 19, 2018

Study Completion

March 19, 2018

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

KR(1)