Healthy SubjectsPhase 1NCT05355077

Evaluate the Pharmacokinetics, Safety and Tolerability of JT001 Tablets

A Phase 1 study testing JT001 200mg Bid, JT001 400mg Bid and JT001 600mg Bid in people with Healthy Subjects, run by Shanghai Vinnerna Biosciences Co., Ltd..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This is a Phase 1, open-label, dose-escalation, multiple-dose study to investigate pharmacokinetics and safety of JT001 (VV116) in Caucasian healthy subjects. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: JT001 200mg Bid, JT001 400mg Bid and JT001 600mg Bid
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 2 May 2022to 24 Oct 2022
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy Caucasian male or female (excluding Middle East) subjects aged 18 to 55 years (inclusive at the time of informed consent). Caucasians are defined as subjects who have 2 parents of Caucasian/European ancestry and 4 grandparents of Caucasian/European ancestry.
Subjects must have a Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening with body weight: male ≥ 50 kg, female ≥ 45 kg.
Subjects must be in good general health, have no clinically significant abnormalities on vital signs, physical examination, laboratory test, ophthalmology, and ECG at Screening and/or before administration of the initial dose of the study drug.
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug and must not be breastfeeding, lactating or planning pregnancy during the study period. WOCBP are defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in the absence of other biological causes. In addition, females under the age of 55 years must have a documented serum follicle stimulating hormone (FSH) level > 40mIU/mL to confirm menopause. Male participants with potentially postmenopausal partners who are under the age of 55 years must use condoms unless their partner's postmenopausal status has been confirmed by FSH level.
Subjects must be willing and able to provide written informed consent after the nature of the study has been explained and before the commencement of any study procedures.

Who cannot join

Known history of allergy to the study drug.
History of severe allergic or anaphylactic reactions.
Subjects with confirmed diseases in the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders, etc., and require medical intervention, or other diseases that are not suitable for participating in clinical studies (such as psychiatric history, etc.). Subjects with mild depression and anxiety may be enrolled if stable and not medicated.
Medical history considered by the Investigator to impact the assessment of PK profiles.
Blood donation or blood loss ≥ 400 mL before screening or has used blood products. Subjects who have donated blood within 1 month or plasma donation within 7 days of Screening will not be included in the study.
Subjects who have received treatment with another investigational drug within 3 months of screening or is participating in another study at the time of screening.

Show all 18Show fewer

Use of any prescription drugs, over the counter (OTC) medication, herbal remedies, supplements, or vitamins within 1 week before screening. Taking paracetamol (up to 2000 mg/day) is allowed.
Subjects with alcohol addiction within 1 year before screening, defined as drinking more than 14 units per week (1 unit is equivalent to approximately 200 mL of beer with 5% alcohol content, or 25 mL of spirits with 40% alcohol content, or 85 mL of wine with 12% alcohol content).
Subjects who have a history of smoking more than 10 cigarettes a day or the equivalent amount within 1 year before screening will not be included. Light smoking (e.g., 10 cigarettes/week) within 1 month prior to screening is acceptable as long as the participant is willing to abstain from smoking during inpatient stay.
Subject is unwilling to abstain from smoking or alcohol during the study.
Positive test for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), Treponema pallidum antibody, and human immunodeficiency virus (HIV) antibody at Screening.
Subjects with abnormal ALT or AST value that is considered clinically by the Investigator at Screening will not be included in the study.
Glomerular filtration rate (eGFR) < lower limit of normal (LLN) at Screening. The CKD-EPI formula will be used for the eGFR calculation.
Abnormal ECG findings considered by the Investigator to be clinically significant, single-examination QTcF (heart rate corrected) > 450 ms in males and > 470 ms in females, and/or other clinically significant abnormalities at Screening.
Pregnant or lactating at Screening or planning to become pregnant (self or partner) from Screening until 3 months after the last administration of the study drug.
Subject is considered to have other factors, in the opinion of the Investigator, which would make it unlikely that the subject will comply with the protocol or complete the study per protocol.
Subjects who received any COVID-19 vaccination within 14 days prior to the first administration of the study drug will not be included in the study.
Any other condition that would, in the Investigator's judgement, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures or interpretation of study results.

About this study

Official title: An Open-label, Dose-Escalation, Multiple-Dose Phase 1 Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of JT001 Tablets in Caucasian Healthy Subjects After Oral Administrations

This is a Phase 1, open-label, dose-escalation, multiple-dose study to investigate pharmacokinetics and safety of JT001 (VV116) in Caucasian healthy subjects.

Read the detailed description

Subjects will be admitted to the Phase 1 clinical study ward on the day before administration (Day -1, baseline phase), and will be confined until all examinations and assessments are completed on Day 8. Subjects will be followed up on Day 12 (± 1 day); if there are abnormalities, an unscheduled visit may be arranged for subjects at the Investigators discretion. Subjects who withdraw early should be encouraged to complete the early withdrawal visit.

At the Screening visit, subjects who are willing to take part in the study will sign informed consent forms (ICFs) and complete the screening examinations. Subjects who meet all of the inclusion criteria and none of the exclusion criteria will be assigned to receive the investigational product (IP) at 1 of the 3 doses according to the dose-escalation scheme, and will be followed up until the 6th day after the last administration.

Time of Collection of PK Blood Samples

To gather the PK data, PK blood samples will be collected at the following specified times:

Day 1: pre-dose (within 1 h before the first administration), and at 10 min, 20 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, and 12 hours after the first administration.

Day 5: pre-dose (within 0.5 hour before each administration) Day 6: pre-dose (within 0.5 hour before administration), and at 10 min, 20 min, 30 min, 45 min, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours, and 48 hours post-dose.

Dose-Escalation Scheme This study consists of 3 dosing group (200, 400, and 600 mg). A dose-escalation design is used, sequentially from the low-dose group to the high-dose group, and each subject will only receive oral administration at one dose level according to the dose-escalation scheme. All subjects will be administered orally twice a day (approximately 12 hours apart) for 6 consecutive days and the last administration will be given in the morning on Day 6. All doses must be taken under fasting conditions.

Conditions: Healthy Subjects
Being tested: JT001 200mg Bid, JT001 400mg Bid, JT001 600mg Bid

What participants receive

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

JT001 200mg BidDrug
Also called VV116
JT001 (VV116):200 mg,oral,Twice a day,6 consecutive days and the last administration will be given in the morning on Day 6
JT001 400mg BidDrug
Also called VV116
JT001 (VV116):400 mg,oral,Twice a day,6 consecutive days and the last administration will be given in the morning on Day 6
JT001 600mg BidDrug
Also called VV116
JT001 (VV116):600 mg,oral,Twice a day,6 consecutive days and the last administration will be given in the morning on Day 6

Study groups in NCT05355077
Study group	Role	What they receive
Group 1	Experimental	JT001 (VV116):200 mg, oral, Twice a day Receives: Drug: JT001 200mg Bid
Group 2	Experimental	JT001 (VV116):400 mg, oral, Twice a day Receives: Drug: JT001 400mg Bid
Group 3	Experimental	JT001 (VV116):600 mg, oral, Twice a day Receives: Drug: JT001 600mg Bid

What is being measured

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

To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Pharmacokinetic (PK) parameters: peak concentration (Cmax) of JT001 (VV116) and its metabolite 116-N1.
Measured: Day 1,Day 5,Day 6:until 48 hours post-dose.
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Pharmacokinetic (PK) parameters : time to peak concentration (Tmax) of JT001 (VV116) and its metabolite 116-N1.
Measured: Day 1,Day 5,Day 6:until 48 hours post-dose.
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Pharmacokinetic (PK) parameters: trough concentration (Ctrough) of JT001 (VV116) and its metabolite 116-N1.
Measured: Day 1,Day 5,Day 6:until 48 hours post-dose.
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Pharmacokinetic (PK) parameters: area under the plasma concentration-time curves (AUC0-t, AUC0-∞, and AUC0-τ) of JT001 (VV116) and its metabolite 116-N1.
Measured: Day 1,Day 5,Day 6:until 48 hours post-dose.
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Pharmacokinetic (PK) parameters: elimination half-life (t1/2) of JT001 (VV116) and its metabolite 116-N1.
Measured: Day 1,Day 5,Day 6:until 48 hours post-dose.
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Pharmacokinetic (PK) parameters: apparent clearance (CL/F) of JT001 (VV116) and its metabolite 116-N1.
Measured: Day 1,Day 5,Day 6:until 48 hours post-dose.
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Pharmacokinetic (PK) parameters: mean residence time (MRT) of JT001 (VV116) and its metabolite 116-N1.
Measured: Day 1,Day 5,Day 6:until 48 hours post-dose.
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Pharmacokinetic (PK) parameters : apparent volume of distribution (Vz/F) Of JT001 (VV116) and its metabolite 116-N1.
Measured: Day 1,Day 5,Day 6:until 48 hours post-dose.
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Pharmacokinetic (PK) parameters: accumulation ratio (Rac) of JT001 (VV116) and its metabolite 116-N1.
Measured: Day 1,Day 5,Day 6:until 48 hours post-dose.

Secondary outcomes (10)

To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Safety data: adverse events (AEs). AEs will be coded using the most current version of the MedDRA® Version 25.0 or higher. The numbers of cases and incidences of all TEAEs, drug-related TEAEs, SAEs, and TEAEs leading to withdrawal should be classified and summarised according to the dose group, SOC, and PT. TEAEs will also be summarised by severity and by relationship to study drug.
Measured: Up to 12 days
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Safety data: vital signs, Respiration(beats per minute) The number and percentages of subjects with abnormal vital signs (respiration, blood pressure, body temperature, and pulse) will be listed and summarised by treatment and protocol specified collection time point. Observed and change from baseline will be summarised at each protocol specified collection time point by dosing group.
Measured: Up to 12 days
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Safety data:vital signs,blood pressure(mm Hg) The number and percentages of subjects with abnormal vital signs (respiration, blood pressure, body temperature, and pulse) will be listed and summarised by treatment and protocol specified collection time point. Observed and change from baseline will be summarised at each protocol specified collection time point by dosing group.
Measured: Up to 12 days
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Safety data:vital signs,body temperature(℃) The number and percentages of subjects with abnormal vital signs (respiration, blood pressure, body temperature, and pulse) will be listed and summarised by treatment and protocol specified collection time point. Observed and change from baseline will be summarised at each protocol specified collection time point by dosing group.
Measured: Up to 12 days
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Safety data:vital signs,pulse(beats per minute) The number and percentages of subjects with abnormal vital signs (respiration, blood pressure, body temperature, and pulse) will be listed and summarised by treatment and protocol specified collection time point. Observed and change from baseline will be summarised at each protocol specified collection time point by dosing group.
Measured: Up to 12 days
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Safety data: laboratory tests,The number and percentages of subjects with abnormal laboratory tests (including haematology, biochemistry, coagulation, and urinalysis) in each dose group will be summarised. All abnormal laboratory test indicators and abnormal clinically significant indicators will be listed.
Measured: Up to 12 days
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Safety data: physical examinations, include general appearance, head, ears, eyes, nose, throat, dentition, thyroid, chest (heart, lungs), abdomen, skin, neurological, extremities, back, neck, musculoskeletal, and lymph nodes.
The number and percentages of subjects with abnormal physical examination in each dose group will be summarised.
Measured: Up to 12 days
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Safety data: 12-lead electrocardiograms (ECGs): heart rate. The number and percentages of subjects with abnormal ECG values will be listed and summarised by treatment by protocol specified collection time point by dosing group.
Measured: Up to 12 days
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Safety data: 12-lead electrocardiograms (ECGs): P-R interval. The number and percentages of subjects with abnormal ECG values will be listed and summarised by treatment by protocol specified collection time point by dosing group.
Measured: Up to 12 days
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Safety data: 12-lead electrocardiograms (ECGs): QTcF interval. The number and percentages of subjects with abnormal ECG values will be listed and summarised by treatment by protocol specified collection time point by dosing group.
Measured: Up to 12 days

Timeline

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

2 May 202224 Oct 2022

First posted2 May 2022
Study start2 May 2022 (estimated)
Primary completion1 Aug 2022 (estimated)
Study completion24 Oct 2022 (estimated)

Why it stopped: Development strategy adjustment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy SubjectsStudies 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: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: Sequential
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05355077
Sponsor's protocol ID: JT001-005-I
Status last verified: Apr 2022
First submitted: 20 Apr 2022
Last updated: 9 Feb 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Dose-Escalation, Multiple-Dose Phase 1 Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of JT001 Tablets in Caucasian Healthy Subjects After Oral Administrations
ClinicalTrials.gov ID: NCT05355077
Acronym / sponsor ID: JT001-005-I
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Development strategy adjustment
Enrolment: 0 participants (actual)
Lead sponsor: Shanghai Vinnerna Biosciences Co., Ltd.Industry (pharma, biotech, devices)
Study start: 2 May 2022 (estimated)
Primary completion: 1 Aug 2022 (estimated)
Study completion: 24 Oct 2022 (estimated)
First posted: 2 May 2022 (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.

This is a Phase 1, open-label, dose-escalation, multiple-dose study to investigate pharmacokinetics and safety of JT001 (VV116) in Caucasian healthy subjects.

Detailed description

Time of Collection of PK Blood Samples

To gather the PK data, PK blood samples will be collected at the following specified times:

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 3
Model description: Sequential

Arm	Type	Receives
Group 1	Experimental	Drug: JT001 200mg BidJT001 (VV116):200 mg, oral, Twice a day
Group 2	Experimental	Drug: JT001 400mg BidJT001 (VV116):400 mg, oral, Twice a day
Group 3	Experimental	Drug: JT001 600mg BidJT001 (VV116):600 mg, oral, Twice a day

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy Caucasian male or female (excluding Middle East) subjects aged 18 to 55 years (inclusive at the time of informed consent). Caucasians are defined as subjects who have 2 parents of Caucasian/European ancestry and 4 grandparents of Caucasian/European ancestry.
Subjects must have a Body Mass Index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening with body weight: male ≥ 50 kg, female ≥ 45 kg.
Subjects must be in good general health, have no clinically significant abnormalities on vital signs, physical examination, laboratory test, ophthalmology, and ECG at Screening and/or before administration of the initial dose of the study drug.
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug and must not be breastfeeding, lactating or planning pregnancy during the study period. WOCBP are defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in the absence of other biological causes. In addition, females under the age of 55 years must have a documented serum follicle stimulating hormone (FSH) level > 40mIU/mL to confirm menopause. Male participants with potentially postmenopausal partners who are under the age of 55 years must use condoms unless their partner's postmenopausal status has been confirmed by FSH level.
Subjects must be willing and able to provide written informed consent after the nature of the study has been explained and before the commencement of any study procedures.

Key exclusion criteria (18 listed)

Known history of allergy to the study drug.
History of severe allergic or anaphylactic reactions.
Subjects with confirmed diseases in the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders, etc., and require medical intervention, or other diseases that are not suitable for participating in clinical studies (such as psychiatric history, etc.). Subjects with mild depression and anxiety may be enrolled if stable and not medicated.
Medical history considered by the Investigator to impact the assessment of PK profiles.
Blood donation or blood loss ≥ 400 mL before screening or has used blood products. Subjects who have donated blood within 1 month or plasma donation within 7 days of Screening will not be included in the study.

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
JT001 200mg BidAlso: VV116JT001 (VV116):200 mg,oral,Twice a day,6 consecutive days and the last administration will be given in the morning on Day 6	Drug	Group 1
JT001 400mg BidAlso: VV116JT001 (VV116):400 mg,oral,Twice a day,6 consecutive days and the last administration will be given in the morning on Day 6	Drug	Group 2
JT001 600mg BidAlso: VV116JT001 (VV116):600 mg,oral,Twice a day,6 consecutive days and the last administration will be given in the morning on Day 6	Drug	Group 3

Primary outcome

To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Time frame: Day 1,Day 5,Day 6:until 48 hours post-dose.
Pharmacokinetic (PK) parameters: peak concentration (Cmax) of JT001 (VV116) and its metabolite 116-N1.
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Time frame: Day 1,Day 5,Day 6:until 48 hours post-dose.
Pharmacokinetic (PK) parameters : time to peak concentration (Tmax) of JT001 (VV116) and its metabolite 116-N1.
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Time frame: Day 1,Day 5,Day 6:until 48 hours post-dose.
Pharmacokinetic (PK) parameters: trough concentration (Ctrough) of JT001 (VV116) and its metabolite 116-N1.
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Time frame: Day 1,Day 5,Day 6:until 48 hours post-dose.
Pharmacokinetic (PK) parameters: area under the plasma concentration-time curves (AUC0-t, AUC0-∞, and AUC0-τ) of JT001 (VV116) and its metabolite 116-N1.
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Time frame: Day 1,Day 5,Day 6:until 48 hours post-dose.
Pharmacokinetic (PK) parameters: elimination half-life (t1/2) of JT001 (VV116) and its metabolite 116-N1.
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Time frame: Day 1,Day 5,Day 6:until 48 hours post-dose.
Pharmacokinetic (PK) parameters: apparent clearance (CL/F) of JT001 (VV116) and its metabolite 116-N1.
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Time frame: Day 1,Day 5,Day 6:until 48 hours post-dose.
Pharmacokinetic (PK) parameters: mean residence time (MRT) of JT001 (VV116) and its metabolite 116-N1.
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Time frame: Day 1,Day 5,Day 6:until 48 hours post-dose.
Pharmacokinetic (PK) parameters : apparent volume of distribution (Vz/F) Of JT001 (VV116) and its metabolite 116-N1.
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Time frame: Day 1,Day 5,Day 6:until 48 hours post-dose.
Pharmacokinetic (PK) parameters: accumulation ratio (Rac) of JT001 (VV116) and its metabolite 116-N1.

10 secondary outcomes

To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Time frame: Up to 12 days
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Time frame: Up to 12 days
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Time frame: Up to 12 days
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Time frame: Up to 12 days
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Time frame: Up to 12 days
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Time frame: Up to 12 days
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Time frame: Up to 12 days
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Time frame: Up to 12 days
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Time frame: Up to 12 days
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Time frame: Up to 12 days

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
Individual participant dataSharing planned: Undecided

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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.

Juan Ma, Master study director

Shanghai Junshi Bioscience Co., Ltd.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JT001 200mg Bid, JT001 400mg Bid and JT001 600mg Bid in people with Healthy Subjects, run by Shanghai Vinnerna Biosciences Co., Ltd..

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 5 inclusion and 18 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: withdrawn, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects (time frame: Day 1,Day 5,Day 6:until 48 hours post-dose.). The study lists 9 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 NCT05355077.

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 9 Feb 2023.