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

NCT01679028 | Completed Phase 1 Results

• 1 other identifier: T89-10-JP
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

T89 Safety in Healthy Japanese population

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Drug Events and Serious Adverse Events

  the Incidence of Adverse Drug Events and serious adverse events

  30 days (after first dosing)

Study Arms (6)

Placebo Group A

PLACEBO COMPARATOR

150mg Placebo Single dose

Drug: Placebo Group A

T89 Group A

EXPERIMENTAL

150mg T89 single dose

Drug: T89 Group A

Placebo Group B

PLACEBO COMPARATOR

300mg placebo single dose

Drug: Placebo Group B

T89 Group B

EXPERIMENTAL

300mg T89 single dose

Drug: T89 Group B

Placebo Group C

PLACEBO COMPARATOR

225mg Placebo bid for 14 days

Drug: Placebo Group C

T89 Group C

EXPERIMENTAL

225mg T89 bid for 14 days

Drug: T89 Group C

Interventions

T89 Group A DRUG

150mg single dose on day 1

Also known as: Dantonic®, Salvtonic®, Compound Danshen Dripping Pills

T89 Group A

Placebo Group A DRUG

150mg single dose

Placebo Group A

Placebo Group B DRUG

300mg single dose

Placebo Group B

T89 Group B DRUG

300mg single dose

Also known as: Dantonic®, Salvtonic®, Compound Danshen Dripping Pills

T89 Group B

Placebo Group C DRUG

225mg bid

Placebo Group C

T89 Group C DRUG

225mg bid

Also known as: Dantonic®, Salvtonic®, Compound Danshen Dripping Pills

T89 Group C

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tasly Pharmaceuticals, Inc.: lead
• Parexel: collaborator

Study Sites (1)

California Clinical Trial Medical Group

Glendale, California, 91206, United States

Location

MeSH Terms

Interventions

T89 herbal drug

Results Point of Contact

• Title: Dr. Henry SUN
• Organization: Tasly Pharmaceuticals, Inc.

henrysunusa@gmail.com

240-744-6225

Study Officials

• Jason GUO, M.D.

  Tasly Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 24, 2012
• First Posted: September 5, 2012
• Study Start: August 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: February 1, 2013
• Last Updated: November 24, 2014
• Results First Posted: November 24, 2014

Record last verified: 2014-11

Locations

US (1)