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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05355077




Registration number
NCT05355077
Ethics application status
Date submitted
20/04/2022
Date registered
2/05/2022
Date last updated
9/02/2023

Titles & IDs
Public title
Evaluate the Pharmacokinetics, Safety and Tolerability of JT001 Tablets
Scientific 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
Secondary ID [1] 0 0
JT001-005-I
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Subjects 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - JT001 200mg Bid
Treatment: Drugs - JT001 400mg Bid
Treatment: Drugs - JT001 600mg Bid

Experimental: Group 1 - JT001 (VV116):200 mg, oral, Twice a day

Experimental: Group 2 - JT001 (VV116):400 mg, oral, Twice a day

Experimental: Group 3 - JT001 (VV116):600 mg, oral, Twice a day


Treatment: Drugs: JT001 200mg Bid
JT001 (VV116):200 mg,oral,Twice a day,6 consecutive days and the last administration will be given in the morning on Day 6

Treatment: Drugs: JT001 400mg Bid
JT001 (VV116):400 mg,oral,Twice a day,6 consecutive days and the last administration will be given in the morning on Day 6

Treatment: Drugs: JT001 600mg Bid
JT001 (VV116):600 mg,oral,Twice a day,6 consecutive days and the last administration will be given in the morning on Day 6
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Timepoint [1] 0 0
Day 1,Day 5,Day 6:until 48 hours post-dose.
Primary outcome [2] 0 0
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Timepoint [2] 0 0
Day 1,Day 5,Day 6:until 48 hours post-dose.
Primary outcome [3] 0 0
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Timepoint [3] 0 0
Day 1,Day 5,Day 6:until 48 hours post-dose.
Primary outcome [4] 0 0
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Timepoint [4] 0 0
Day 1,Day 5,Day 6:until 48 hours post-dose.
Primary outcome [5] 0 0
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Timepoint [5] 0 0
Day 1,Day 5,Day 6:until 48 hours post-dose.
Primary outcome [6] 0 0
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Timepoint [6] 0 0
Day 1,Day 5,Day 6:until 48 hours post-dose.
Primary outcome [7] 0 0
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Timepoint [7] 0 0
Day 1,Day 5,Day 6:until 48 hours post-dose.
Primary outcome [8] 0 0
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Timepoint [8] 0 0
Day 1,Day 5,Day 6:until 48 hours post-dose.
Primary outcome [9] 0 0
To explore the pharmacokinetics of JT001 and its prominent metabolite 116-N1 in Caucasian healthysubjects
Timepoint [9] 0 0
Day 1,Day 5,Day 6:until 48 hours post-dose.
Secondary outcome [1] 0 0
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Timepoint [1] 0 0
Up to 12 days
Secondary outcome [2] 0 0
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Timepoint [2] 0 0
Up to 12 days
Secondary outcome [3] 0 0
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Timepoint [3] 0 0
Up to 12 days
Secondary outcome [4] 0 0
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Timepoint [4] 0 0
Up to 12 days
Secondary outcome [5] 0 0
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Timepoint [5] 0 0
Up to 12 days
Secondary outcome [6] 0 0
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Timepoint [6] 0 0
Up to 12 days
Secondary outcome [7] 0 0
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Timepoint [7] 0 0
Up to 12 days
Secondary outcome [8] 0 0
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Timepoint [8] 0 0
Up to 12 days
Secondary outcome [9] 0 0
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Timepoint [9] 0 0
Up to 12 days
Secondary outcome [10] 0 0
To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.
Timepoint [10] 0 0
Up to 12 days

Eligibility
Key inclusion criteria
1. 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.

2. 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.

3. 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.

4. 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.

5. 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Known history of allergy to the study drug.

2. History of severe allergic or anaphylactic reactions.

3. 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.

4. Medical history considered by the Investigator to impact the assessment of PK
profiles.

5. 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.

6. 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.

7. 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.

8. 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).

9. 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.

10. Subject is unwilling to abstain from smoking or alcohol during the study.

11. 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.

12. Subjects with abnormal ALT or AST value that is considered clinically by the
Investigator at Screening will not be included in the study.

13. Glomerular filtration rate (eGFR) < lower limit of normal (LLN) at Screening. The
CKD-EPI formula will be used for the eGFR calculation.

14. 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.

15. 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.

16. 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.

17. 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.

18. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
2/05/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/10/2022
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Shanghai Vinnerna Biosciences Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05355077
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Juan Ma, Master
Address 0 0
Shanghai Junshi Bioscience Co., Ltd.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05355077