Healthy Chinese VolunteersPhase 1NCT03610867
To Evaluate the Safety, Tolerability, and Pharmacokinetics Profile in Healthy Chinese Volunteers of TG-2349
A Phase 1 study testing Furaprevir capsule (SAD) and Furaprevir capsule (MAD) in people with Healthy Chinese Volunteers, run by Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of different doses of TG-2349 (Furaprevir capsule) in healthy Chinese volunteers. 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?
- Furaprevir capsule (SAD) and Furaprevir capsule (MAD)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2017to 31 Aug 2017
- 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 Institutional 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 and male body weight ≥ 50 kg, female body weight ≥ 45 kg；
- In generally good physical and mental health status on basis of a 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
- Had undergone surgical sterilization, or
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- Subjects of childbearing potential must satisfy the following criteria:
- Before group assignment, the 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 signing ICF to the last visit). Subjects must also consent to keep the contraceptive method unchanged until 1 month after the study, and Breastfeeding is prohibited
- Males 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 signing ICF to the last visit)；
- Have not used tobacco or nicotine-containing products within 1 month prior to the first dose of study drug；
- Have not drunk alcohol beverages or drank alcoholic beverages less than 12 times within 3 months prior to the 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 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；
- Any clinical significant abnormality on chest X-rays or abdominal ultrasound scan at screening；
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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 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 Furaprevir 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) drug, 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, sucralfate, antacid, nutritional supplements, multi-vitamin, supplements for metals) within 7 days prior to the first dose of study drug；
- 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 Phase I, Randomized, Double-blind, Placebo Controlled, Ascending Dose Study in Healthy Chinese Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) Profile of Single and Multiple Ascending Oral Doses of TG-2349
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of different doses of TG-2349 (Furaprevir capsule) in healthy Chinese volunteers.
Read the detailed description
This study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile in healthy Chinese volunteers with single or multiple ascending oral doses of TG-2349 (Furaprevir capsule). The study is separated into two parts, part A and part B.
Part A：To evaluate the safety, tolerability, and PK profile of single ascending oral dose (100 mg, 200 mg, 400 mg, and 600 mg) of TG-2349 in healthy Chinese volunteers.
Part B：To evaluate the safety, tolerability, and PK profile of multiple ascending oral doses (200 mg, 400 mg, and 600 mg) of TG-2349 for five days in healthy Chinese volunteers.
- Conditions
- Healthy Chinese Volunteers
- Being tested
- Furaprevir capsule (SAD), Furaprevir capsule (MAD), Placebo (SAD), Placebo (MAD)
- Keywords
- safety, tolerability, PK, single ascending oral dose, multiple ascending oral doses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furaprevir capsule (SAD)Drug
Also called TG-2349 (SAD)
There are four doses in this part, 100 mg, 200 mg, 400 mg, and 600 mg. Each subject will receive the sample once by oral administration.
Furaprevir capsule (MAD)Drug
Also called TG-2349 (MAD)
There are three doses in this part, 200 mg, 400 mg, and 600 mg. Each subject will be allocated into one dosing regimen and receive the sample once daily for 5 consecutive days by oral administration.
Placebo (SAD)Drug
Each subject will receive the sample once by oral administration.
Placebo (MAD)Drug
Each subject will be allocated into one dosing regimen and receive the sample once daily for 5 consecutive days by oral administration.
| Study group | Role | What they receive |
|---|---|---|
| Furaprevir capsule (SAD) | Experimental | single ascending oral dose (100 mg, 200 mg, 400 mg, and 600 mg) of TG-2349 (Furaprevir capsule) Receives: Drug: Furaprevir capsule (SAD) |
| Placebo (SAD) | Placebo comparator | Single ascending oral dose of Furaprevir similar capsule.
. Receives: Drug: Placebo (SAD) |
| Furaprevir capsule (MAD) | Experimental | multiple ascending oral doses (200 mg, 400 mg, and 600 mg) of TG-2349 (Furaprevir capsule) Receives: Drug: Furaprevir capsule (MAD) |
| Placebo (MAD) | Placebo comparator | Multiple ascending oral doses of Furaprevir similar capsule Receives: Drug: Placebo (MAD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (Maximum Plasma Concentration)
Maximum Plasma Concentration
Measured: 10 days
Tmax (Time at Which Maximum Plasma Concentration is Observed)
Time at Which Maximum Plasma Concentration is Observed
Measured: 10 days
AUC (Area Under the Plasma Concentration)
Area Under the Plasma Concentration
Measured: 10 days
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
CTCAE v4.0
Measured: 10 days
Secondary outcomes (12)
12-lead ECG (electrocardiogram)
Measured: 10 days
blood pressure (mmHg)
Vital signs
Measured: 10 days
pulse (beats/ min)
Vital signs
Measured: 10 days
respiratory rate (breaths/ min)
Vital signs
Measured: 10 days
body temperature (oC)
Vital signs
Measured: 10 days
General Appearance Physical examination
Physical examination
Measured: 10 days
Skin Physical examination
Physical examination
Measured: 10 days
Head and Neck Physical examination
Physical examination
Measured: 10 days
Chest region Physical examination
Physical examination
Measured: 10 days
Abdominal region Physical examination
Physical examination
Measured: 10 days
Back region Physical examination
Physical examination
Measured: 10 days
Extremities Physical examination
Physical examination
Measured: 10 days
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 start27 Apr 2017
- Primary completion31 Aug 2017
- Study completion31 Aug 2017
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 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, PhD, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03610867
- Sponsor's protocol ID
- TG-2349-C-01
- Status last verified
- Aug 2018
- First submitted
- 6 May 2018
- Last updated
- 2 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 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo Controlled, Ascending Dose Study in Healthy Chinese Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) Profile of Single and Multiple Ascending Oral Doses of TG-2349
- ClinicalTrials.gov ID
- NCT03610867
- Acronym / sponsor ID
- TG-2349-C-01
- Conditions
- Healthy Chinese Volunteers
- Keywords
- safety, tolerability, PK, single ascending oral dose, multiple ascending oral doses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Dongguan HEC TaiGen Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- R&G Pharma Studies Co.,Ltd.
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (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.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of different doses of TG-2349 (Furaprevir capsule) in healthy Chinese volunteers.
Detailed description
This study is to evaluate the safety, tolerability, and pharmacokinetics (PK) profile in healthy Chinese volunteers with single or multiple ascending oral doses of TG-2349 (Furaprevir capsule). The study is separated into two parts, part A and part B.
Part A：To evaluate the safety, tolerability, and PK profile of single ascending oral dose (100 mg, 200 mg, 400 mg, and 600 mg) of TG-2349 in healthy Chinese volunteers.
Part B：To evaluate the safety, tolerability, and PK profile of multiple ascending oral doses (200 mg, 400 mg, and 600 mg) of TG-2349 for five days in healthy Chinese volunteers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Furaprevir capsule (SAD) | Experimental | Drug: Furaprevir capsule (SAD)single ascending oral dose (100 mg, 200 mg, 400 mg, and 600 mg) of TG-2349 (Furaprevir capsule) |
| Placebo (SAD) | Placebo comparator | Drug: Placebo (SAD)Single ascending oral dose of Furaprevir similar capsule. . |
| Furaprevir capsule (MAD) | Experimental | Drug: Furaprevir capsule (MAD)multiple ascending oral doses (200 mg, 400 mg, and 600 mg) of TG-2349 (Furaprevir capsule) |
| Placebo (MAD) | Placebo comparator | Drug: Placebo (MAD)Multiple ascending oral doses of Furaprevir similar capsule |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Before starting the study, an informed consent form (ICF) approved by the Institutional 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 and male body weight ≥ 50 kg, female body weight ≥ 45 kg；
- In generally good physical and mental health status on basis of a 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
Key exclusion criteria (24 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 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；
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 |
|---|---|---|
| Furaprevir capsule (SAD)Also: TG-2349 (SAD)There are four doses in this part, 100 mg, 200 mg, 400 mg, and 600 mg. Each subject will receive the sample once by oral administration. | Drug | Furaprevir capsule (SAD) |
| Furaprevir capsule (MAD)Also: TG-2349 (MAD)There are three doses in this part, 200 mg, 400 mg, and 600 mg. Each subject will be allocated into one dosing regimen and receive the sample once daily for 5 consecutive days by oral administration. | Drug | Furaprevir capsule (MAD) |
| Placebo (SAD)Each subject will receive the sample once by oral administration. | Drug | Placebo (SAD) |
| Placebo (MAD)Each subject will be allocated into one dosing regimen and receive the sample once daily for 5 consecutive days by oral administration. | Drug | Placebo (MAD) |
Primary outcome
Cmax (Maximum Plasma Concentration)
Time frame: 10 days
Maximum Plasma Concentration
Tmax (Time at Which Maximum Plasma Concentration is Observed)
Time frame: 10 days
Time at Which Maximum Plasma Concentration is Observed
AUC (Area Under the Plasma Concentration)
Time frame: 10 days
Area Under the Plasma Concentration
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 10 days
CTCAE v4.0
12 secondary outcomes
12-lead ECG (electrocardiogram)
Time frame: 10 days
blood pressure (mmHg)
Time frame: 10 days
pulse (beats/ min)
Time frame: 10 days
respiratory rate (breaths/ min)
Time frame: 10 days
body temperature (oC)
Time frame: 10 days
General Appearance Physical examination
Time frame: 10 days
Skin Physical examination
Time frame: 10 days
Head and Neck Physical examination
Time frame: 10 days
Chest region Physical examination
Time frame: 10 days
Abdominal region Physical examination
Time frame: 10 days
Back region Physical examination
Time frame: 10 days
Extremities Physical examination
Time frame: 10 days
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 2 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, PhD 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 Furaprevir capsule (SAD) and Furaprevir capsule (MAD) 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 12 inclusion and 24 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 2 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. 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?
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 (Maximum Plasma Concentration) (time frame: 10 days). The study lists 4 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 2 Aug 2018.