Tolerability, Safety and Pharmacokinetic Study Of Methosulide in Healthy Adult Subjects

Hubei Biological Medicine Industrial Technology Institute Co., Ltd.

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Methosulide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02374684

HubeiBMITI- CM2010-01-I

Details and patient eligibility

About

The purpose of this study is to determine the safety and tolerability, and to evaluate the pharmacokinetic characteristics and food effect of Methosulide after oral administration in healthy adult subjects.

Full description

1. Dose-escalation study of single oral administration of Methosulide in healthy adults to assess the safety and tolerability.
2. Multiple-dose study of Methosulide in healthy adults to assess the safety and tolerability.
3. Dose-escalation study of single oral administration of Methosulide in healthy adults to evaluate the pharmacokinetic characteristics
4. Multiple-dose study of Methosulide in healthy adults to evaluate the pharmacokinetics characteristics
5. Single dose,and cross-over study of Methosulide in healthy adults to evaluate the pharmacokinetic characteristics and effect of food.

Enrollment: 92 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female, between 18 and 45 years of age, Body Mass Index (BMI) between 19～25 kg/m2, Weight > or = 50kg
• In good health as judged by the investigator
• Without history of medication within 2 weeks before the test
• Non-allergic constitution, without known drug allergy
• Without history of major organ diseases
• Without other factors affecting drug metabolism, such as smoking (within 2 weeks), drinking (within 2 weeks), or drug abuse history
• Signed informed consent form and Fully understood the contents, process and possible adverse reactions of the test

Exclusion criteria

• History of kinds of food or drug allergy, or suffering from allergic diseases or allergic constitution
• Presence (in screening stage) or history of the acute/chronic organic diseases or clinical manifestations: blood system, renal disease, endocrine system, respiratory system, digestive system, cardiovascular system, nervous system, mental disease, allergic diseases (including drug allergy, but not including non-treatment, asymptomatic, seasonal allergy during the period of oral administration)
• History of abuse of Smoking, alcohol, or other drugs
• Severe hemorrhage factors to affect the venous blood collection
• Severe blood loss or blood donation within 3 months before the test
• Participation in other drug trials within 3 months before the test
• Usage of drugs known to have damage to the main organs within 3 months before the test
• Without good compliance, or unable to match with the test
• with a clinically significant abnormality in routine serological detection: including Hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infected
• For childbearing-aged women only, usage of any hormonal contraceptive methods within 3 months before the drug administration; or unable or unwilling to use non-hormonal contraceptive methods to contraception from the day of dosing until 14 days after dosing
• Be otherwise unsuitable for the study, in the opinion of the Investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups, including a placebo group

Methosulide

Experimental group

Description:

Methosulide, oral administration

Treatment:

Drug: Methosulide

Placebo

Placebo Comparator group

Description:

Placebo, oral administration

Treatment:

Drug: Placebo