CompletedNCT01679028Updated Nov 24, 2014Results posted

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

A Phase 1 interventional study of T89 Group A and Placebo Group A in Healthy, sponsored by Tasly Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 20 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-11-24.

Sponsored by Tasly Pharmaceuticals, Inc. · Phase 1 and Interventional

Phase: Phase 1
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 20 Years to 55 Years
Sex: All

Study 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.

Read the detailed description

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.

Conditions studied

Healthy

Keywords

T89 Safety in Healthy Japanese population

In context

Lead sponsor

Tasly Pharmaceuticals, Inc. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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.

Study design

Phase: Phase 1
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 20 participants (actual)

Study arms

Placebo comparator
Placebo Group A
150mg Placebo Single dose
Drug: Placebo Group A
Experimental
T89 Group A
150mg T89 single dose
Drug: T89 Group A
Placebo comparator
Placebo Group B
300mg placebo single dose
Drug: Placebo Group B
Experimental
T89 Group B
300mg T89 single dose
Drug: T89 Group B
Placebo comparator
Placebo Group C
225mg Placebo bid for 14 days
Drug: Placebo Group C
Experimental
T89 Group C
225mg T89 bid for 14 days
Drug: T89 Group C

Interventions

DrugT89 Group A
150mg single dose on day 1
Also known as: Dantonic®, Salvtonic®, Compound Danshen Dripping Pills
DrugPlacebo Group A
150mg single dose
DrugPlacebo Group B
300mg single dose
DrugT89 Group B
300mg single dose
Also known as: Dantonic®, Salvtonic®, Compound Danshen Dripping Pills
DrugPlacebo Group C
225mg bid
DrugT89 Group C
225mg bid
Also known as: Dantonic®, Salvtonic®, Compound Danshen Dripping Pills

What researchers measure

Primary outcomes

Incidence of Adverse Drug Events and Serious Adverse Events
the Incidence of Adverse Drug Events and serious adverse events
Time frame: 30 days (after first dosing)

Results

Posted Nov 24, 2014

Participant flow

Study Initiation Date: Auguest 1st, 2012 Study Completion Date: October 20th, 2012 Location: Phase I clinical Study Center: California Clinical Trials Medical Group 1509 Wilson Terrace Glendale, CA 91206

Participant flow — Overall Study
Milestone	Placebo Group A	T89 Group A	Placebo Group B	T89 Group B	Placebo Group C	T89 Group C
Started	2	4	2	4	2	6
Completed	2	4	2	4	2	6
Not completed	0	0	0	0	0	0

Outcome measures

PrimaryIncidence of Adverse Drug Events and Serious Adverse Events

the Incidence of Adverse Drug Events and serious adverse events

Time frame:: 30 days (after first dosing)
Reported as:: Number · adverse event

Incidence of Adverse Drug Events and Serious Adverse Events
adverse event	Placebo Group A	T89 Group A	Placebo Group B	T89 Group B	Placebo Group C	T89 Group C
Incidence of Adverse Drug Events and Serious Adverse Events	0	0	0	0	0	1

Adverse events

Collected over 30 days after the last dose.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo Group A	—	0/2 (0%)	0/2 (0%)
T89 Group A	—	0/4 (0%)	0/4 (0%)
Placebo Group B	—	0/2 (0%)	0/2 (0%)
T89 Group B	—	0/4 (0%)	0/4 (0%)
Placebo Group C	—	0/2 (0%)	0/2 (0%)
T89 Group C	—	0/6 (0%)	1/6 (16.7%)

Most frequent other events

Most frequent other events
Event	Placebo Group A	T89 Group A	Placebo Group B	T89 Group B	Placebo Group C	T89 Group C
SomnolenceGeneral disorders	0/2	0/4	0/2	0/4	0/2	1/6

Baseline characteristics

Placebo Group A: 2 T89 Group A: 4 Placebo Group B: 2 T89 Group B: 4 Placebo Group C: 2 T89 Group C: 6

Age, Continuous
Age, Continuous(years)	Placebo Group A	T89 Group A	Placebo Group B	T89 Group B	Placebo Group C	T89 Group C	Total
Mean	27 ± 3	24 ± 2	24.5 ± 4.9	24 ± 2.2	47.5 ± 6.4	40.6 ± 9.9	32.5 ± 11.0

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo Group A	T89 Group A	Placebo Group B	T89 Group B	Placebo Group C	T89 Group C	Total
Female	0	0	0	0	0	1	1
Male	2	4	2	4	2	5	19

Region of Enrollment
Region of Enrollment(participants)	Placebo Group A	T89 Group A	Placebo Group B	T89 Group B	Placebo Group C	T89 Group C	Total
United States	2	4	2	4	2	6	20

Study locations

1 site

California Clinical Trial Medical Group
Glendale, California 91206, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01679028
Lead sponsor: Tasly Pharmaceuticals, Inc.
Collaborators: Parexel
Responsible party: Sponsor
First posted: Sep 5, 2012
Start date: Aug 2012
Primary completion: Oct 2012
Completion: Feb 2013
Results posted: Nov 24, 2014
Last update: Nov 24, 2014

Study contacts

Jason GUO, M.D.

study director · Tasly Pharmaceuticals, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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