Healthy Chinese VolunteersPhase 1NCT03610880
To Evaluate PK and Safety Profile of Oral MAD of Separately Using TG-2349, DAG181 or Combination in Healthy Chinese Volunteers
A Phase 1 study testing TG-2349 (400 mg) plus DAG181 (200 mg) and DAG181 (200 mg) plus TG-2349 (400 mg) in people with Healthy Chinese Volunteers, run by Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
To evaluate the drug-drug reactions between TG-2349 and DAG181, and the pharmacokinetics and tolerability profile in healthy Chinese volunteers to be the reference for protocol designs of subsequent clinical trials. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Chinese Volunteers
- What is being tested?
- TG-2349 (400 mg) plus DAG181 (200 mg) and DAG181 (200 mg) plus TG-2349 (400 mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2017to 5 Feb 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Before starting the study, an informed consent form (ICF) approved by the Institute Review Board (IRB) is obtained from the subject or his/her legal representative；
- Male or female, and 18 to 45 years of age inclusive when signing ICF；
- Body mass index (BMI) in the range of 19.0 to 24.0 kg/m2 inclusive and male body weight ≥ 50 kg, female body weight ≥ 45 kg；
- In general good physical and mental health status on basis of medical history review, physical examination and vital signs, 12-lead ECG, and laboratory results at screening；
- For females, one of the following criteria must be fulfilled: (a) Had undergone surgical sterilization, or (b) Subjects of childbearing potential must satisfy the following criteria: Before group assignment, the urine pregnancy test is negative, and Subjects agree to use an approved contraceptive method (i.e. oral spermicidal agent, condoms, or intrauterine devices) during the entire study period (from Visit1 to Visit 2). Subject must also consent to keep the contraceptive method until 1 month after the study, and Breastfeeding is prohibited；
- Male must be willing to use a reliable form of contraception (use of a condom or spouses using any of the above standards) during the entire study period (from Visit1 to Visit 2) and within 1 month after the study；
- Have not used tobacco or nicotine-containing products within 1 month period to first dose of study drug；
- Willing to abstain from caffeine- or xanthine-containing beverages, including coffee and tea, chocolate, alcohol, grapefruit juice, and Seville oranges juice before 24 hr and during the Stay-on Site period.
Who cannot join
- Current, prior history, or family history of any disease of sudden cardiac death, myocardial ischemia, myocardial infarction, congestive heart failure, QT prolongation syndrome, hypokalemia, myocarditis, exertional dyspnea, cerebrovascular injury, venous thromboembolism；
- Requires concomitant medication associated with increased QTc interval (i.e. Class I or III antiarrhythmic agents, refer to appendix 1) or with cardiac insufficiency；
- Any abnormality on 12-lead ECG: PR>240 ms, PR<110 ms, QRS>110 ms, QTc>450 ms, or bradycardia ( heart rate < 50 beats/min) at screening or the day -1；
- Any clinical significant abnormality on 12-lead ECG (i.e. atrioventricular block, TdT, other types of ventricular tachycardia, atrial fibrillation and ventricular flutter, clinical significant abnormality on T wave changes or any abnormality on 12-lead ECG that effects QTc intervals) at screening or the day -1；
- Systolic pressure >140 mmHg or <90 mmHg, diastolic pressure >90 mmHg, pulse <50 beats/min or >100 beats/min at screening or the day -1；筛选或研究第-1天时收缩压>140 mmHg或<90 mmHg、舒张压>90 mmHg、脉搏<50次/分或>100次/分；
- Any clinical significant abnormality on chest X-rays or abdominal ultrasound scan at screening (or within 2 weeks of signing the ICF)；
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- Positive serological test for hepatitis A (IgM anti-HAV), hepatitis B (HbsAg), hepatitis C (anti-HCV antibody), or syphilis at screening；
- Pregnant or breastfeeding；
- Any abnormal laboratory values (normal value ±10％) that are considered clinical significant by the Investigator at screening or the day -1；
- Positive breath alcohol test or urine drug screen at screening or the day -1；
- Current or prior history of any disease of diabetes, cardiovascular, hepatic or renal impairment；
- Any dysphagia, malabsorption syndrome, or other gastrointestinal disturbances affecting drug absorption；
- Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy；
- History of epileptic seizure, mental disorders affecting the subject's compliance with the protocol, suicidal risk, or a history of alcohol or illicit drug abuse；
- Currently has any disease that seriously affects the immune system, for instance, human immunodeficiency virus (HIV) infection, hematological malignancy, solid cancer or splenectomy；
- Allergy, hypersensitivity or allergic reaction to TG-2349 or its excipients, DAG181 or its excipients,or Sulfonamides；
- History of surgery within 6 months prior to the first dose of study drug；
- Received any hepatic enzyme inducers or hepatic enzyme inhibitors within 30 days prior to the first dose of study drug through medical history questionnaire (refer to appendix 2)；
- Received any investigational drugs within 3 months prior to the first dose of study drug；
- Received any prescription drugs, over-the-counter (OTC) drugs, or Chinese herbal medicines within 14 days prior to the first dose of study drug；
- Received any nutritional supplies, including multivalent cations products (i.e. Ca-, Al-, Mg-, Fe-, and Zn-containing products, nutritional supplements, multi-vitamin, supplements for metals) within 7 days prior to the first dose of study drug；
- History of alcohol misuse (14 units alcohol/ week: 1 unit equal to bear 285 mL, spirits 25 mL, or wine 100 mL)；
- Blood donation ≥400 ml within 3 months prior to the first dose of study drug；
- Any disease or situation that would affect the safety of study drug or pharmacokinetics profile by Investigators' judgments；
- As determined by Investigator, a subject is not suitable to take part in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Open-label, Two-arm, Parallel Design Study to Evaluate PK and Safety Profile of Multiple Ascending Oral Doses of Separately Using TG-2349 or DAG181 or TG-2349 Plus DAG181 in Healthy Chinese Volunteers
To evaluate the drug-drug reactions between TG-2349 and DAG181, and the pharmacokinetics and tolerability profile in healthy Chinese volunteers to be the reference for protocol designs of subsequent clinical trials.
Read the detailed description
This is a single center, randomized, open-label, two-arm, parallel design, phase I study that using TG-2349 or DAG181 alone, or TG-2349 plus DAG181 to evaluate the drug-drug reactions, the pharmacokinetics, and tolerability profile in healthy Chinese volunteers. The results will be the reference for protocol designs of subsequent clinical trials.
- Conditions
- Healthy Chinese Volunteers
- Being tested
- TG-2349 (400 mg) plus DAG181 (200 mg), DAG181 (200 mg) plus TG-2349 (400 mg)
- Keywords
- healthy Chinese volunteers, TG-2349, DAG181, pharmacokinetics, safety, multiple ascending oral doses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TG-2349 (400 mg) plus DAG181 (200 mg)Drug
Dosing period 1 (Day 1 to 7): TG-2349 400 mg； Dosing period 2 (Day 8 to 14): TG-2349 400 mg + DAG181 200 mg
DAG181 (200 mg) plus TG-2349 (400 mg)Drug
Dosing period 1 (Day 1 to 7): DAG181 200 mg； Dosing period 2 (Day 8 to 14): TG-2349 400 mg + DAG181 200 mg
| Study group | Role | What they receive |
|---|---|---|
| TG-2349 (400 mg) plus DAG181 (200 mg) | Experimental | Dosing period 1 (Day 1 to 7): TG-2349 alone；Dosing period 2 (Day 8 to 14): TG-2349+DAG181 Receives: Drug: TG-2349 (400 mg) plus DAG181 (200 mg) |
| DAG181 (200 mg) plus TG-2349 (400 mg) | Experimental | Dosing period 1 (Day 1 to 7): DAG181 alone；Dosing period 2 (Day 8 to 14): TG-2349+DAG181 Receives: Drug: DAG181 (200 mg) plus TG-2349 (400 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax(ss)
Maximum Plasma Concentration in a stable state
Measured: 14 weeks
Ctrough(ss)
Trough Plasma Concentration in a stable state
Measured: 14 weeks
AUC(0-τ, ss)
Area Under the Plasma Concentration vs. Time Curve
Measured: 14 weeks
Secondary outcomes (25)
Cmax
Cmax: Maximum Plasma Concentration,
Measured: 14 weeks
Ctrough
Ctrough: Trough Plasma Concentration
Measured: 14 weeks
Tmax
Time at Which Maximum Plasma Concentration is Observed
Measured: 14 weeks
AUC(0-24)
AUC(0-24): Area Under the Plasma Concentration vs. Time Curve 0-24 hours
Measured: 14 weeks
Tmax(ss)
Tmax(ss): Time at Which Maximum Plasma Concentration is Observed in a stable state
Measured: 14 weeks
λz
λz: Terminal disposition rate constant/terminal rate constant
Measured: 14 weeks
AUC(0-last)
AUC(0-last): Area Under the Plasma Concentration vs. Time Curve 0 - the last dose
Measured: 14 weeks
AUC(0-inf)
AUC(0-inf): Area Under the Plasma Concentration vs. Time Curve 0 - infinity
Measured: 14 weeks
MRT
MRT: mean residence time
Measured: 14 weeks
CL/F
CL/F: total clearance rate
Measured: 14 weeks
V/F
V/F: apparent volume of distribution
Measured: 14 weeks
DF
DF=(Cmax - Ctrough) / (AUCss /τ)
Measured: 14 weeks
12-lead ECG
including heart rate, RR, PR, QRS, QT, QTc；
Measured: 19 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
CTCAE v4.0
Measured: 19 weeks
blood pressure (mmHg)
Vital signs
Measured: 19 weeks
pulse (beats/ min)
Vital signs
Measured: 19 weeks
respiratory rate (breaths/ min)
Vital signs
Measured: 19 weeks
body temperature (oC)
Vital signs
Measured: 19 weeks
General Appearance Physical examination
Physical examination
Measured: 19 weeks
Skin Physical examination
Physical examination
Measured: 19 weeks
Head and Neck Physical examination
Physical examination
Measured: 19 weeks
Chest region Physical examination
Physical examination
Measured: 19 weeks
Abdominal region Physical examination
Physical examination
Measured: 19 weeks
Back region Physical examination
Physical examination
Measured: 19 weeks
Extremities Physical examination
Physical examination
Measured: 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start17 Oct 2017
- Primary completion5 Feb 2018
- Study completion5 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Chinese VolunteersStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, open-label, two-arm, parallel design
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- R&G Pharma Studies Co.,Ltd.
- Responsible party
- Sponsor
- Investigators
- Pingsheng Xu, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610880
- Sponsor's protocol ID
- TGDAG-C-1
- Status last verified
- Jul 2018
- First submitted
- 24 May 2018
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Open-label, Two-arm, Parallel Design Study to Evaluate PK and Safety Profile of Multiple Ascending Oral Doses of Separately Using TG-2349 or DAG181 or TG-2349 Plus DAG181 in Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT03610880
- Acronym / sponsor ID
- TGDAG-C-1
- Conditions
- Healthy Chinese Volunteers
- Keywords
- healthy Chinese volunteers, TG-2349, DAG181, pharmacokinetics, safety, multiple ascending oral doses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- R&G Pharma Studies Co.,Ltd.
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 5 Feb 2018 (actual)
- Study completion
- 5 Feb 2018 (actual)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the drug-drug reactions between TG-2349 and DAG181, and the pharmacokinetics and tolerability profile in healthy Chinese volunteers to be the reference for protocol designs of subsequent clinical trials.
Detailed description
This is a single center, randomized, open-label, two-arm, parallel design, phase I study that using TG-2349 or DAG181 alone, or TG-2349 plus DAG181 to evaluate the drug-drug reactions, the pharmacokinetics, and tolerability profile in healthy Chinese volunteers. The results will be the reference for protocol designs of subsequent clinical trials.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, open-label, two-arm, parallel design
| Arm | Type | Receives |
|---|---|---|
| TG-2349 (400 mg) plus DAG181 (200 mg) | Experimental | Drug: TG-2349 (400 mg) plus DAG181 (200 mg)Dosing period 1 (Day 1 to 7): TG-2349 alone；Dosing period 2 (Day 8 to 14): TG-2349+DAG181 |
| DAG181 (200 mg) plus TG-2349 (400 mg) | Experimental | Drug: DAG181 (200 mg) plus TG-2349 (400 mg)Dosing period 1 (Day 1 to 7): DAG181 alone；Dosing period 2 (Day 8 to 14): TG-2349+DAG181 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Before starting the study, an informed consent form (ICF) approved by the Institute Review Board (IRB) is obtained from the subject or his/her legal representative；
- Male or female, and 18 to 45 years of age inclusive when signing ICF；
- Body mass index (BMI) in the range of 19.0 to 24.0 kg/m2 inclusive and male body weight ≥ 50 kg, female body weight ≥ 45 kg；
- In general good physical and mental health status on basis of medical history review, physical examination and vital signs, 12-lead ECG, and laboratory results at screening；
- For females, one of the following criteria must be fulfilled: (a) Had undergone surgical sterilization, or (b) Subjects of childbearing potential must satisfy the following criteria: Before group assignment, the urine pregnancy test is negative, and Subjects agree to use an approved contraceptive method (i.e. oral spermicidal agent, condoms, or intrauterine devices) during the entire study period (from Visit1 to Visit 2). Subject must also consent to keep the contraceptive method until 1 month after the study, and Breastfeeding is prohibited；
Key exclusion criteria (25 listed)
- Current, prior history, or family history of any disease of sudden cardiac death, myocardial ischemia, myocardial infarction, congestive heart failure, QT prolongation syndrome, hypokalemia, myocarditis, exertional dyspnea, cerebrovascular injury, venous thromboembolism；
- Requires concomitant medication associated with increased QTc interval (i.e. Class I or III antiarrhythmic agents, refer to appendix 1) or with cardiac insufficiency；
- Any abnormality on 12-lead ECG: PR>240 ms, PR<110 ms, QRS>110 ms, QTc>450 ms, or bradycardia ( heart rate < 50 beats/min) at screening or the day -1；
- Any clinical significant abnormality on 12-lead ECG (i.e. atrioventricular block, TdT, other types of ventricular tachycardia, atrial fibrillation and ventricular flutter, clinical significant abnormality on T wave changes or any abnormality on 12-lead ECG that effects QTc intervals) at screening or the day -1；
- Systolic pressure >140 mmHg or <90 mmHg, diastolic pressure >90 mmHg, pulse <50 beats/min or >100 beats/min at screening or the day -1；筛选或研究第-1天时收缩压>140 mmHg或<90 mmHg、舒张压>90 mmHg、脉搏<50次/分或>100次/分；
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 |
|---|---|---|
| TG-2349 (400 mg) plus DAG181 (200 mg)Dosing period 1 (Day 1 to 7): TG-2349 400 mg； Dosing period 2 (Day 8 to 14): TG-2349 400 mg + DAG181 200 mg | Drug | TG-2349 (400 mg) plus DAG181 (200 mg) |
| DAG181 (200 mg) plus TG-2349 (400 mg)Dosing period 1 (Day 1 to 7): DAG181 200 mg； Dosing period 2 (Day 8 to 14): TG-2349 400 mg + DAG181 200 mg | Drug | DAG181 (200 mg) plus TG-2349 (400 mg) |
Primary outcome
Cmax(ss)
Time frame: 14 weeks
Maximum Plasma Concentration in a stable state
Ctrough(ss)
Time frame: 14 weeks
Trough Plasma Concentration in a stable state
AUC(0-τ, ss)
Time frame: 14 weeks
Area Under the Plasma Concentration vs. Time Curve
25 secondary outcomes
Cmax
Time frame: 14 weeks
Ctrough
Time frame: 14 weeks
Tmax
Time frame: 14 weeks
AUC(0-24)
Time frame: 14 weeks
Tmax(ss)
Time frame: 14 weeks
λz
Time frame: 14 weeks
AUC(0-last)
Time frame: 14 weeks
AUC(0-inf)
Time frame: 14 weeks
MRT
Time frame: 14 weeks
CL/F
Time frame: 14 weeks
V/F
Time frame: 14 weeks
DF
Time frame: 14 weeks
12-lead ECG
Time frame: 19 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 19 weeks
blood pressure (mmHg)
Time frame: 19 weeks
pulse (beats/ min)
Time frame: 19 weeks
respiratory rate (breaths/ min)
Time frame: 19 weeks
body temperature (oC)
Time frame: 19 weeks
General Appearance Physical examination
Time frame: 19 weeks
Skin Physical examination
Time frame: 19 weeks
Head and Neck Physical examination
Time frame: 19 weeks
Chest region Physical examination
Time frame: 19 weeks
Abdominal region Physical examination
Time frame: 19 weeks
Back region Physical examination
Time frame: 19 weeks
Extremities Physical examination
Time frame: 19 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
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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.
Pingsheng Xu principal investigator
Xiangya Hospital of Central South University
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 TG-2349 (400 mg) plus DAG181 (200 mg) and DAG181 (200 mg) plus TG-2349 (400 mg) in people with Healthy Chinese Volunteers, run by Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd. at 1 site in China.
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 8 inclusion and 25 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 1 Aug 2018. 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 China. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cmax(ss) (time frame: 14 weeks). The study lists 3 primary outcomes in all. 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 1 Aug 2018.