A Study of the Safety, Tolerability and Pharmacokinetics of HMPL-523

NCT02105129 | Completed Phase 1 DMC

• 1 other identifier: 2014-523-00AU1
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the safety and tolerability of a single dose of up to 800 mg in Part A (evaluated in planned steps of 5, 20, 50, 100, 200, 300 mg under fasted conditions, followed by 300, 400, 600 and 800 mg HMPL-523 under fed conditions of a standard meal, followed by multiple doses of 200, 300, 400 and 500 mg of HMPL-523 in Part B, in healthy male volunteers. The secondary objective is to determine the pharmacokinetic profile of single (Part A) and multiple (Part B) oral doses of HMPL-523 in healthy male volunteers and to determine the preliminary effect of food (Part C）

Conditions

Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (1)

• To assess number of participants with adverse events as a measure of safety and tolerability during dose escalating

  6 months

Secondary Outcomes (1)

• To measure the plasma concentration of HMPL-523 in single and repeated doses

  6 months

Study Arms (2)

HMPL-523

EXPERIMENTAL

Single/Multiple Ascending Dose. oral administration, a single dose of 5, 20, 50, 100, 200 and 300 mg (Part A) and multiple dose of HMPL-523 at dose level based on result of Part A

Drug: HMPL-523

Placebo

PLACEBO COMPARATOR

Placebo: oral administration

Drug: Placebo

Interventions

HMPL-523 DRUG

HMPL-523: Oral administration with a single dose of 5, 20, 50, 100, 200 and 300 mg in Part A, followed by multiple doses of selected strength in Part B Other Name: NA

Also known as: HMPL-523 acetate

HMPL-523

Placebo DRUG

Oral administration

Also known as: HMPL-523 Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent must be obtained in writing for all subjects before enrollment into the study
• Healthy male subjects aged 18 to 45years inclusive at the time of screening
• Body mass index ≥19.0 and ≤ 30.0 kg/m2
• No clinically significant abnormalities as determined by medical history and physical examination, especially with regard to the liver, bile and gastrointestinal systems
• No clinically significant laboratory values and urinalysis, as determined by the clinical Investigator.
• No clinically significant findings in ECG, blood pressure and heart rate, as determined by the clinical Investigator.
• Willing to comply with the contraceptive requirements of the study and must not donate sperm during the study or for 3 months afterwards. Subjects must agree to use a condom or to abstain from sexual intercourse throughout the trial and for 30 days afterwards.

You may not qualify if:

• Family history of premature Coronary Heart Disease
• Any condition requiring the regular use of any medication
• Exposure to prescription medications or to drugs known to interfere with metabolism of drugs within 30 days prior to Day 1
• Exposure to any other medication, including over-the counter medications, herbal remedies and vitamins 14 days prior to first dose
• Participation in another study with any investigational drug in the 30 days preceding Day 1 of the study
• Treatment in the previous 3 months with any drug known to have a well defined potential for toxicity to a major organ
• Current smoker of more than 10 cigarettes or equivalent / day prior to commencing the study and unable to completely stop smoking during the study
• Symptoms of a clinically significant illness in the 3 months before the study
• Presence or sequelae of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
• Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease, Hemorrhoids or anal diseases with regular or recent presence of blood in feces
• History of significant allergic disease (e.g. Allergic to medications) and acute phase of allergic rhinitis in the previous 2 weeks before randomization or any food allergy
• Blood or plasma donation of more than 500 ml during the previous 30 Days before randomization and/or more than 50 ml in the 2 weeks prior to screening
• Known positive test for HIV
• Known positive test for hepatitis B or C, unless caused by immunization
• Current evidence of drug abuse or history of drug abuse within one year before randomization

Sponsors & Collaborators

• Hutchison Medipharma Limited: lead

Study Sites (1)

Nucleus Network Limited

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jason Lickliter, MD

  Nucleus Network Ltd

  PRINCIPAL INVESTIGATOR

• Yan Wu, MD

  Hutchison Medipharma Limited

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: April 7, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 28, 2016

Record last verified: 2016-04

Locations

AU (1)