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

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tasly Pharmaceuticals, Inc.
• Collaborator: Parexel

Criteria

Inclusion Criteria:

1. Healthy male and female volunteers aged between 20-55 years.

2. First generation of Japanese, and live in the U.S.A. less than 5 years and maintained Japanese lifestyle.

3. The body mass index between 18 and 30 kg/m2.

4. 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.

5. ECG with no clinically significant abnormalities.

6. No clinically significant medical history.

7. Vital signs and laboratory tests with no clinically significant abnormalities.

8. 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.

9. Volunteers must understand and be willing, able and likely to comply with all study procedures and restrictions.

10. Volunteers must be able to give voluntary written informed consent.

Exclusion Criteria:

1. History of uncontrolled, clinically significant neurologic, cardiovascular, haematological, pulmonary, hepatic, renal, metabolic, GI, urologic, immunologic, endocrine or psychiatric disease.

2. 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.

3. 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.

4. Blood donor in recent 3 months.

5. Have taken part in other clinical trials involving administration of study medications in the previous 1 month before participation.

6. 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).

7. 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)

8. Known hypersensitivity to any of the ingredients of T89 or other relevant drug allergy.