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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03278470
• Date of registration: 07/09/2017
• Prospective Registration: No
• Primary sponsor: Hanlim Pharm. Co., Ltd.
• Public title: A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject
• Scientific title: 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
• Date of first enrolment: June 26, 2017
• Target sample size: 57
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03278470
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Korea, Republic of

Key inclusion & exclusion criteria

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.)



Age minimum: 20 Years
Age maximum: 45 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: HL237

Drug: Placebo Oral Tablet

Primary Outcome(s)

half life [t1/2] [Time Frame: 3days after administration]

Maximum Plasma Concentration [Cmax] [Time Frame: 3days after administration]

Area Under the Curve [AUC] [Time Frame: 3days after administration]

Secondary Outcome(s)

Number of participants with treatment-related adverse events [Time Frame: 14days after administration]

Secondary ID(s)

HL-237-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors