Healthy Chinese VolunteersPhase 1NCT04495322

To Evaluate the Safety, Tolerability, and Pharmacokinetics Profiles of TG-1000 in Healthy Volunteers, and the Food Effect on Pharmacokinetics of Single Oral Dose of TG-1000 in Healthy Volunteers.

A Phase 1 study testing TG-1000 in people with Healthy Chinese Volunteers, run by TaiGen Biotechnology Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics profiles of TG-1000 in healthy volunteers, and to evaluate the food effect on pharmacokinetics of single oral dose of TG-1000 in healthy 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?: TG-1000
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 66 participants
Where: 1 siteChina
Study dates: 17 Jul 2020to 30 Dec 2020
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

Willing to provide written informed consent.
Age 18 (or legal adult age) to 45 years.
Body mass index (BMI) in the range of ≥19.0 to ≤ 24.0 kg/m2 and body weight ≥ 50 kg for male and ≥ 45 kg for female at Screening.
Subjects have good communication with Investigator and agree to follow the study requirement to complete study.

Who cannot join

Clinically significant abnormality in 12-lead ECG, chest X-ray, abdominal ultrasounds, physical examination, vital signs or laboratory values at Screening or Day-1.
Positive breath alcohol or urine drug tests at Day-1.
Positive test results for Immunoglobulin M anti-HAV antibody, HBsAg, anti-HCV antibody, HIV or syphilis at Screening.
Female subjects with positive pregnancy test results at Screening or Day-1.
Male subjects are unwilling to use effective contraception and refrain from sperm donation from Screening until 3 months after the study drug administration.
Current or prior history of any of the following:

Show all 17Show fewer

Significant cardiac disease, diabetes, liver, kidney disease, psychiatric diseases or drug abuse or diseases that will affect immunity.
Difficulty in swallow or gastrointestinal disorder that could interfere with the absorption of the study drug
Difficulty in blood sampling or venipuncture
Drug allergy or hypersensitivity
Blood donation ≥ 400 mL within 3 months before and after study.
Alcoholics or frequent drinkers prior to Screening.
Frequent smokers prior to Screening.
Use of any prohibited medications or surgeries prior to study drug administration:
Received any other investigational agents or devices, liver enzyme inducer or inhibitors, medications including prescriptions, non-prescriptions or herbal remedies, dietary supplements or surgeries.
Unwilling to abstain from alcohol, tobacco, nicotine containing products, caffeine- or xanthine-containing beverages from Screening until discharge from the phase I unit.
Subjects may not be qualified for the study judged by the Investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Xiangya Hospital of Central South University
Changsha, Hunan

Other trials in China

About this study

Official title: A Phase 1, Single-center, Randomized, Double-blind, Placebo-controlled, Single-dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Profiles of TG-1000 in Healthy Volunteers, and to Evaluate the Food Effect on Pharmacokinetics of Single Oral Dose of TG-1000 in Healthy Volunteers.

Read the detailed description

This is a phase 1, single-center, randomized, double-blind, placebo-controlled, single-dose escalation study to evaluate the safety, tolerability, and pharmacokinetics profiles of TG-1000 in healthy volunteers, and to evaluate the food effect on pharmacokinetics of single oral dose of TG-1000 in healthy volunteers. The study will be divided into two parts.

Part A is designed as randomized, double-blind, placebo-controlled, sequential, single ascending oral dose to evaluate the safety, tolerability, and PK profiles of TG-1000 in healthy volunteers.

Part B is designed as randomized, open-label, two treatment (fasted vs. fed), two-period, two-sequence crossover to compare the effects of food on the Pharmacokinetic (PK) of single oral dose of TG-1000 in healthy subjects.

Conditions: Healthy Chinese Volunteers
Being tested: TG-1000, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TG-1000Drug
Subjects will receive one single oral dose of TG-1000 on day 1 following protocol requirements.
PlaceboDrug
Subjects will receive one single oral dose of placebo on day 1 following protocol requirements.

Study groups in NCT04495322
Study group	Role	What they receive
10 mg TG-1000	Experimental	Eligible subjects will receive single oral dose of study drug (2 x 5-mg TG-1000 capsules)on Day 1 under fasted condition. Receives: Drug: TG-1000
20 mg TG-1000 or Placebo	Experimental	Eligible subjects will receive single oral dose of study drug (20 mg TG-1000 capsule or Placebo capsule) on Day 1 under fasted condition. Receives: Drug: TG-1000; Drug: Placebo
40 mg TG-1000 or Placebo	Experimental	Eligible subjects will receive single oral dose of study drug (2 x 20 mg TG-1000 capsules or Placebo capsules) on Day 1 under fasted condition. Receives: Drug: TG-1000; Drug: Placebo
80 mg TG-1000 or Placebo	Experimental	Eligible subjects will receive single oral dose of study drug (4 x 20 mg TG-1000 capsules or Placebo capsules) on Day 1 under fasted condition. Receives: Drug: TG-1000; Drug: Placebo
120 mg TG-1000 or Placebo	Experimental	Eligible subjects will receive single oral dose of study drug (6 x 20 mg TG-1000 capsules or Placebo capsules) on Day 1 under fasted condition. Receives: Drug: TG-1000; Drug: Placebo
160 mg TG-1000 or Placebo	Experimental	Eligible subjects will receive single oral dose of study drug (8 x 20 mg TG-1000 capsules or Placebo capsules) on Day 1 under fasted condition. Receives: Drug: TG-1000; Drug: Placebo
X mg TG-1000 (fasted)+wash-out+X mg TG-1000 (fed)	Experimental	Based on the preliminary results, one optimal dose (X mg) of TG-1000 will be selected. Subject will receive a single oral dose of TG-1000 under fasted condition. After washout period, subject will receive a single oral dose of TG-1000 under fed condition. Receives: Drug: TG-1000
X mg TG-1000 (fed)+wash-out+X mg TG-1000 (fasted)	Experimental	Based on the preliminary results, one optimal dose (X mg) of TG-1000 will be selected. Subject will receive a single oral dose of TG-1000 under fed condition. After washout period, subject will receive a single oral dose of TG-1000 under fasted condition. Receives: Drug: TG-1000

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of subjects of treatment-emergent adverse events
Any significant findings after dosing will be considered as adverse events.
Measured: 8 days
Number of subjects of Significant Abnormal Vital Signs Findings
The systolic and diastolic blood pressure (mmHg), pulse/heart rate (beats/min), respiratory rate (breaths/min), and body temperature (oC) will be measured.
Measured: 8 days
Number of subjects With Significant Abnormal Physical Examination Findings
A full general physical examination of the major body systems (General Appearance; Dermatological including skin and nails; Head and Neck; Chest region including Heart and Lung; Abdominal region including Gastrointestinal and Gastroenterology; Back region; Extremities; Psychiatric or Neurological; Lymph nodes; Other) will be performed by investigator.
Measured: 8 days.
Number of subjects With Significant Abnormal 12-lead Electrocardiography (ECG) Findings
12-lead ECG will be performed after a rest in a supine position. The following ECG parameters will be listed: heart rate, the time between QRS complexes (RR Interval) (ms), the beginning of the P wave to the first deflection of the QRS complex (PR Interval) (ms), first deflection of QRS complex to end of QRS complex at isoelectric line (QRS duration) (ms), first deflection of QRS complex to end of T wave at isoelectric line (QT interval) (ms), Corrected QT interval by Bazett (QTcB) (ms), and Corrected QT interval by - Fridericia (QTcF) (ms).
Measured: 8 days
Number of subjects With Significant Abnormal Holter Electrocardiography (ECG) Findings
Holter ECG will be monitor continue from 12 hr pre-dose until 24 hr post-dose. The Investigator will determine whether the results of the Holter monitoring are normal or abnormal.
Measured: 12 hr pre-dose until 24 hr post-dose
Number of Participants With Significant Abnormal Laboratory Values
Chemistry, Hematology, Coagulation, Urinalysis, Human Immunodeficiency Virus (HIV) test, Hepatitis A virus(HAV) test, Hepatitis B virus (HBV) test, Hepatitis C virus (HCV) test, syphilis, serum pregnancy tests and Breath Alcohol Test
Measured: 8 days
Peak Plasma Concentration (Cmax)
Blood sample will be collected to evaluate PK profile and food effect of TG-1000.
Measured: 15 days
time to Cmax (Tmax)
Blood sample will be collected to evaluate PK profile of TG-1000.
Measured: 15 days
area under the curve from time zero to the time (AUC0-t)
Blood sample will be collected to evaluate PK profile and food effect of TG-1000.
Measured: 15 days
area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)
Blood sample will be collected to evaluate PK profile of TG-1000.
Measured: 15 days
area under the concentration-time curve from time zero to infinity (AUC0-inf)
Blood sample will be collected to evaluate PK profile and food Effect of TG-1000.
Measured: 15 days
terminal elimination half-life (T1/2, z)
Blood sample will be collected to evaluate PK profile of TG-1000.
Measured: 15 days
apparent total body clearance (CL/F)
Blood sample will be collected to evaluate PK profile of TG-1000.
Measured: 15 days
apparent total volume distribution (V/F)
Blood sample will be collected to evaluate PK profile of TG-1000.
Measured: 15 days
plasma concentration 24 h after dosing (C24)
Blood sample will be collected to evaluate PK profile of TG-1000.
Measured: 15 days
urinary excretion ratio relative to dose from time zero to the time (Feu0-t)
Urine sample will be collected to evaluate PK profile of TG-1000.
Measured: 15 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jul 202030 Dec 2020

First posted31 Jul 2020
Study start17 Jul 2020
Primary completion26 Nov 2020
Study completion30 Dec 2020

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: single-center, randomized, double-blind, placebo-controlled, single-dose
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04495322
Sponsor's protocol ID: TG-1000-C-01
Status last verified: Jan 2021
First submitted: 22 Jul 2020
Last updated: 7 Jan 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Single-center, Randomized, Double-blind, Placebo-controlled, Single-dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Profiles of TG-1000 in Healthy Volunteers, and to Evaluate the Food Effect on Pharmacokinetics of Single Oral Dose of TG-1000 in Healthy Volunteers.
ClinicalTrials.gov ID: NCT04495322
Acronym / sponsor ID: TG-1000-C-01
Conditions: Healthy Chinese Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: TaiGen Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: R&G Pharma Studies Co.,Ltd.
Study start: 17 Jul 2020 (actual)
Primary completion: 26 Nov 2020 (actual)
Study completion: 30 Dec 2020 (actual)
First posted: 31 Jul 2020 (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.

Detailed description

Part A is designed as randomized, double-blind, placebo-controlled, sequential, single ascending oral dose to evaluate the safety, tolerability, and PK profiles of TG-1000 in healthy volunteers.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8
Model description: single-center, randomized, double-blind, placebo-controlled, single-dose

Arm	Type	Receives
10 mg TG-1000	Experimental	Drug: TG-1000Eligible subjects will receive single oral dose of study drug (2 x 5-mg TG-1000 capsules)on Day 1 under fasted condition.
20 mg TG-1000 or Placebo	Experimental	Drug: TG-1000, Drug: PlaceboEligible subjects will receive single oral dose of study drug (20 mg TG-1000 capsule or Placebo capsule) on Day 1 under fasted condition.
40 mg TG-1000 or Placebo	Experimental	Drug: TG-1000, Drug: PlaceboEligible subjects will receive single oral dose of study drug (2 x 20 mg TG-1000 capsules or Placebo capsules) on Day 1 under fasted condition.
80 mg TG-1000 or Placebo	Experimental	Drug: TG-1000, Drug: PlaceboEligible subjects will receive single oral dose of study drug (4 x 20 mg TG-1000 capsules or Placebo capsules) on Day 1 under fasted condition.
120 mg TG-1000 or Placebo	Experimental	Drug: TG-1000, Drug: PlaceboEligible subjects will receive single oral dose of study drug (6 x 20 mg TG-1000 capsules or Placebo capsules) on Day 1 under fasted condition.
160 mg TG-1000 or Placebo	Experimental	Drug: TG-1000, Drug: PlaceboEligible subjects will receive single oral dose of study drug (8 x 20 mg TG-1000 capsules or Placebo capsules) on Day 1 under fasted condition.
X mg TG-1000 (fasted)+wash-out+X mg TG-1000 (fed)	Experimental	Drug: TG-1000Based on the preliminary results, one optimal dose (X mg) of TG-1000 will be selected. Subject will receive a single oral dose of TG-1000 under fasted condition. After washout period, subject will receive a single oral dose of TG-1000 under fed condition.
X mg TG-1000 (fed)+wash-out+X mg TG-1000 (fasted)	Experimental	Drug: TG-1000Based on the preliminary results, one optimal dose (X mg) of TG-1000 will be selected. Subject will receive a single oral dose of TG-1000 under fed condition. After washout period, subject will receive a single oral dose of TG-1000 under fasted condition.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Willing to provide written informed consent.
Age 18 (or legal adult age) to 45 years.
Body mass index (BMI) in the range of ≥19.0 to ≤ 24.0 kg/m2 and body weight ≥ 50 kg for male and ≥ 45 kg for female at Screening.
Subjects have good communication with Investigator and agree to follow the study requirement to complete study.

Key exclusion criteria (17 listed)

Clinically significant abnormality in 12-lead ECG, chest X-ray, abdominal ultrasounds, physical examination, vital signs or laboratory values at Screening or Day-1.
Positive breath alcohol or urine drug tests at Day-1.
Positive test results for Immunoglobulin M anti-HAV antibody, HBsAg, anti-HCV antibody, HIV or syphilis at Screening.
Female subjects with positive pregnancy test results at Screening or Day-1.
Male subjects are unwilling to use effective contraception and refrain from sperm donation from Screening until 3 months after the study drug administration.

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-1000Subjects will receive one single oral dose of TG-1000 on day 1 following protocol requirements.	Drug	10 mg TG-1000, 120 mg TG-1000 or Placebo, 160 mg TG-1000 or Placebo, 20 mg TG-1000 or Placebo, 40 mg TG-1000 or Placebo, 80 mg TG-1000 or Placebo, X mg TG-1000 (fasted)+wash-out+X mg TG-1000 (fed), X mg TG-1000 (fed)+wash-out+X mg TG-1000 (fasted)
PlaceboSubjects will receive one single oral dose of placebo on day 1 following protocol requirements.	Drug	120 mg TG-1000 or Placebo, 160 mg TG-1000 or Placebo, 20 mg TG-1000 or Placebo, 40 mg TG-1000 or Placebo, 80 mg TG-1000 or Placebo

Primary outcome

Number of subjects of treatment-emergent adverse events
Time frame: 8 days
Any significant findings after dosing will be considered as adverse events.
Number of subjects of Significant Abnormal Vital Signs Findings
Time frame: 8 days
The systolic and diastolic blood pressure (mmHg), pulse/heart rate (beats/min), respiratory rate (breaths/min), and body temperature (oC) will be measured.
Number of subjects With Significant Abnormal Physical Examination Findings
Time frame: 8 days.
A full general physical examination of the major body systems (General Appearance; Dermatological including skin and nails; Head and Neck; Chest region including Heart and Lung; Abdominal region including Gastrointestinal and Gastroenterology; Back region; Extremities; Psychiatric or Neurological; Lymph nodes; Other) will be performed by investigator.
Number of subjects With Significant Abnormal 12-lead Electrocardiography (ECG) Findings
Time frame: 8 days
12-lead ECG will be performed after a rest in a supine position. The following ECG parameters will be listed: heart rate, the time between QRS complexes (RR Interval) (ms), the beginning of the P wave to the first deflection of the QRS complex (PR Interval) (ms), first deflection of QRS complex to end of QRS complex at isoelectric line (QRS duration) (ms), first deflection of QRS complex to end of T wave at isoelectric line (QT interval) (ms), Corrected QT interval by Bazett (QTcB) (ms), and Corrected QT interval by - Fridericia (QTcF) (ms).
Number of subjects With Significant Abnormal Holter Electrocardiography (ECG) Findings
Time frame: 12 hr pre-dose until 24 hr post-dose
Holter ECG will be monitor continue from 12 hr pre-dose until 24 hr post-dose. The Investigator will determine whether the results of the Holter monitoring are normal or abnormal.
Number of Participants With Significant Abnormal Laboratory Values
Time frame: 8 days
Chemistry, Hematology, Coagulation, Urinalysis, Human Immunodeficiency Virus (HIV) test, Hepatitis A virus(HAV) test, Hepatitis B virus (HBV) test, Hepatitis C virus (HCV) test, syphilis, serum pregnancy tests and Breath Alcohol Test
Peak Plasma Concentration (Cmax)
Time frame: 15 days
Blood sample will be collected to evaluate PK profile and food effect of TG-1000.
time to Cmax (Tmax)
Time frame: 15 days
Blood sample will be collected to evaluate PK profile of TG-1000.
area under the curve from time zero to the time (AUC0-t)
Time frame: 15 days
Blood sample will be collected to evaluate PK profile and food effect of TG-1000.
area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last)
Time frame: 15 days
Blood sample will be collected to evaluate PK profile of TG-1000.
area under the concentration-time curve from time zero to infinity (AUC0-inf)
Time frame: 15 days
Blood sample will be collected to evaluate PK profile and food Effect of TG-1000.
terminal elimination half-life (T1/2, z)
Time frame: 15 days
Blood sample will be collected to evaluate PK profile of TG-1000.
apparent total body clearance (CL/F)
Time frame: 15 days
Blood sample will be collected to evaluate PK profile of TG-1000.
apparent total volume distribution (V/F)
Time frame: 15 days
Blood sample will be collected to evaluate PK profile of TG-1000.
plasma concentration 24 h after dosing (C24)
Time frame: 15 days
Blood sample will be collected to evaluate PK profile of TG-1000.
urinary excretion ratio relative to dose from time zero to the time (Feu0-t)
Time frame: 15 days
Urine sample will be collected to evaluate PK profile of TG-1000.

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 7 Jan 2021.
Individual participant dataSharing planned: No

Related trials for Healthy Chinese Volunteers

Active, not recruitingPhase 1
A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity or Overweight
Healthy Volunteers, Overweight or Obesity
RecruitingPhase 1
A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers
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RecruitingPhase 1
A Study of LY5625575 in Healthy Participants and in Participants With Inflammation (Elevated C-Reactive Protein)
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Recruiting
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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-1000 in people with Healthy Chinese Volunteers, run by TaiGen Biotechnology 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 4 inclusion and 17 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 7 Jan 2021. 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?

Number of subjects of treatment-emergent adverse events (time frame: 8 days). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04495322.

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 7 Jan 2021.