HealthyPhase 1NCT01679028
Dose-Escalate Study to Investigate the Safety and Tolerability of T89 in Japanese
A Phase 1 study testing T89 Group A and T89 Group B in people with Healthy, run by Tasly Pharmaceuticals, Inc. at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- T89 Group A and T89 Group B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Feb 2013
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Clinical Trial Medical Group
Glendale, California, 91206
About this study
Official title: Single- and Multiple- Dose-Escalation Study to Investigate the Safety and Tolerability of T89 in Japanese Healthy Volunteers
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
- Healthy
- Being tested
- T89 Group A, Placebo Group A, Placebo Group B, T89 Group B, Placebo Group C
- Keywords
- T89 Safety in Healthy Japanese population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T89 Group ADrug
Also called Dantonic®, Salvtonic®, Compound Danshen Dripping Pills
150mg single dose on day 1
Placebo Group ADrug
150mg single dose
Placebo Group BDrug
300mg single dose
T89 Group BDrug
Also called Dantonic®, Salvtonic®, Compound Danshen Dripping Pills
300mg single dose
Placebo Group CDrug
225mg bid
T89 Group CDrug
Also called Dantonic®, Salvtonic®, Compound Danshen Dripping Pills
225mg bid
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group A | Placebo comparator | 150mg Placebo Single dose Receives: Drug: Placebo Group A |
| T89 Group A | Experimental | 150mg T89 single dose Receives: Drug: T89 Group A |
| Placebo Group B | Placebo comparator | 300mg placebo single dose Receives: Drug: Placebo Group B |
| T89 Group B | Experimental | 300mg T89 single dose Receives: Drug: T89 Group B |
| Placebo Group C | Placebo comparator | 225mg Placebo bid for 14 days Receives: Drug: Placebo Group C |
| T89 Group C | Experimental | 225mg T89 bid for 14 days Receives: Drug: T89 Group C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Drug Events and Serious Adverse Events
the Incidence of Adverse Drug Events and serious adverse events
Measured: 30 days (after first dosing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Jason GUO, M.D., Study director, Tasly Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679028
- Sponsor's protocol ID
- T89-10-JP
- Status last verified
- Nov 2014
- First submitted
- 24 Aug 2012
- Last updated
- 24 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single- and Multiple- Dose-Escalation Study to Investigate the Safety and Tolerability of T89 in Japanese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01679028
- Acronym / sponsor ID
- T89-10-JP
- Conditions
- Healthy
- Keywords
- T89 Safety in Healthy Japanese population
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tasly Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- Aug 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 5 Sep 2012 (estimated)
- Results
- Posted 24 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo Group A | Placebo comparator | Drug: Placebo Group A150mg Placebo Single dose |
| T89 Group A | Experimental | Drug: T89 Group A150mg T89 single dose |
| Placebo Group B | Placebo comparator | Drug: Placebo Group B300mg placebo single dose |
| T89 Group B | Experimental | Drug: T89 Group B300mg T89 single dose |
| Placebo Group C | Placebo comparator | Drug: Placebo Group C225mg Placebo bid for 14 days |
| T89 Group C | Experimental | Drug: T89 Group C225mg T89 bid for 14 days |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T89 Group AAlso: Dantonic®, Salvtonic®, Compound Danshen Dripping Pills150mg single dose on day 1 | Drug | T89 Group A |
| Placebo Group A150mg single dose | Drug | Placebo Group A |
| Placebo Group B300mg single dose | Drug | Placebo Group B |
| T89 Group BAlso: Dantonic®, Salvtonic®, Compound Danshen Dripping Pills300mg single dose | Drug | T89 Group B |
| Placebo Group C225mg bid | Drug | Placebo Group C |
| T89 Group CAlso: Dantonic®, Salvtonic®, Compound Danshen Dripping Pills225mg bid | Drug | T89 Group C |
Primary outcome
Incidence of Adverse Drug Events and Serious Adverse Events
Time frame: 30 days (after first dosing)
the Incidence of Adverse Drug Events and serious adverse events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason GUO, M.D. study director
Tasly Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing T89 Group A and T89 Group B in people with Healthy, run by Tasly Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Drug Events and Serious Adverse Events (time frame: 30 days (after first dosing)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2014.