Dose-Escalate Study to Investigate the Safety and Tolerability of T89 in Japanese

Study Overview
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Brief Summary
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The purpose of this study is to see how safe an investigational new drug (T89) is and how well healthy Japanese subjects tolerate it when given two single doses and a multiple dose.

Detailed Description
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This is a single centre, double-blind, randomized, placebo controlled, single- and multiple- dose-escalation study. After informed consent is obtained, subjects were evaluated with a medical history questionnaire, physical examination, blood and urine collections for clinical laboratory safety tests, urine drug screen, serum pregnancy test for each women, vital signs and ECG. The subjects who fulfill the inclusion criteria but no exclusion criteria were provisionally enrolled. For participation in this trial, subjects were instructed to avoid any prescription, over-the-counter (OTC), and alternative / complementary medications or significant changes in diet without advance permission from principal investigator. The subjects were instructed to discontinue alcohol, caffeine and bromine containing beverage/food. 20 subjects were enrolled and divided into three Groups: Group A, Group B and Group C.

Official Title
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Single- and Multiple- Dose-Escalation Study to Investigate the Safety and Tolerability of T89 in Japanese Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: T89 Group A
* Drug: Placebo Group A
* Drug: Placebo Group B
* Drug: T89 Group B
* Drug: Placebo Group C
* Drug: T89 Group C


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female volunteers aged between 20-55 years. First generation of Japanese, and live in the U.S.A. less than 5 years and maintained Japanese lifestyle. The body mass index between 18 and 30 kg/m2. Willing to not take alcoholic beverages, and caffeine- and the bromine-containing beverages and foods (e.g., tea, coffee, chocolate, cola, etc.) for the duration of the study beginning at the screening visit. ECG with no clinically significant abnormalities. No clinically significant medical history. Vital signs and laboratory tests with no clinically significant abnormalities. Volunteers had not taken any medication that would interfere with the procedures or interpretation of study data or compromise subject safety within 4 weeks prior to the first dose, per principal investigator discretion. Volunteers must understand and be willing, able and likely to comply with all study procedures and restrictions. Volunteers must be able to give voluntary written informed consent. Exclusion Criteria: History of uncontrolled, clinically significant neurologic, cardiovascular, haematological, pulmonary, hepatic, renal, metabolic, GI, urologic, immunologic, endocrine or psychiatric disease. Pregnant or nursing mother - Women of childbearing potential must have a negative pregnancy test, not be breast feeding and be established on a method of contraception that in the investigator's opinion is acceptable. Have on-going other treatment or medicine that may interfere with T89 or administration of similar medication within 2 weeks of entering study, per principal investigator discretion. Blood donor in recent 3 months. Have taken part in other clinical trials involving administration of study medications in the previous 1 month before participation. Excessive alcohol use (habitually consumed more than 21 units of alcohol per week or has a history of alcohol abuse as defined by DSM-IV-TR criteria (a unit of alcohol is equal to 1 ounce of hard liquor, 5 ounces of wine or 8 ounces of beer within past two years). History or evidence of habitual use of tobacco or nicotine containing products within 3 months of Screening, with the exception of light smoking (up to 5 cigarettes per day or the equivalent) Known hypersensitivity to any of the ingredients of T89 or other relevant drug allergy.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group A<br>150mg Placebo Single dose | Drug: Placebo Group A<br>* 150mg single dose<br>|
| Experimental: T89 Group A<br>150mg T89 single dose | Drug: T89 Group A<br>* 150mg single dose on day 1<br>* Other names: Compound Danshen Dripping Pills;|
| Placebo Comparator: Placebo Group B<br>300mg placebo single dose | Drug: Placebo Group B<br>* 300mg single dose<br>|
| Experimental: T89 Group B<br>300mg T89 single dose | Drug: T89 Group B<br>* 300mg single dose<br>* Other names: Compound Danshen Dripping Pills;|
| Placebo Comparator: Placebo Group C<br>225mg Placebo bid for 14 days | Drug: Placebo Group C<br>* 225mg bid<br>|
| Experimental: T89 Group C<br>225mg T89 bid for 14 days | Drug: T89 Group C<br>* 225mg bid<br>* Other names: Compound Danshen Dripping Pills;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Drug Events and Serious Adverse Events | the Incidence of Adverse Drug Events and serious adverse events | 30 days (after first dosing) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T89 Safety in Healthy Japanese population