Evaluate the Pharmacokinetics, Safety and Tolerability of JT001 Tablets

NCT05355077 | Withdrawn Phase 1

• 1 other identifier: JT001-005-I
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Up to 12 days

• To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.

  Up to 12 days

• To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.

  Up to 12 days

• To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.

  Up to 12 days

• To evaluate the safety and tolerability of JT001 tablets in Caucasian healthy subjects after multiple dosesoral administrations.

  Up to 12 days

Study Arms (3)

Group 1

EXPERIMENTAL

JT001 (VV116):200 mg, oral, Twice a day

Drug: JT001 200mg Bid

Group 2

EXPERIMENTAL

JT001 (VV116):400 mg, oral, Twice a day

Drug: JT001 400mg Bid

Group 3

EXPERIMENTAL

JT001 (VV116):600 mg, oral, Twice a day

Drug: JT001 600mg Bid

Interventions

JT001 200mg Bid DRUG

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

Also known as: VV116

Group 1

JT001 400mg Bid DRUG

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

Also known as: VV116

Group 2

JT001 600mg Bid DRUG

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

Also known as: VV116

Group 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Vinnerna Biosciences Co., Ltd.: lead

MeSH Terms

Interventions

GS-621763; BID protein, human

Study Officials

• Juan Ma, Master

  Shanghai Junshi Bioscience Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: May 2, 2022
• Study Start: May 2, 2022
• Primary Completion: August 1, 2022
• Study Completion: October 24, 2022
• Last Updated: February 9, 2023

Record last verified: 2022-04