A Study in Elderly Chinese Subjects With Underlying Diseases

NCT06093308 | Completed Phase 1

• 1 other identifier: JT001-017-I
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the safety and tolerability of oral JT001 tablets in elderly subjects with underlying diseases. Evaluate the pharmacokinetic characteristics of JT001 tablets orally administered to elderly subjects with underlying diseases. Explore the drug drug interactions between JT001 tablets and some drugs in elderly subjects with underlying diseases who have been orally administered multiple times.

Conditions

Elderly Subjects With Underlying Diseases

Outcome Measures

Primary Outcomes (26)

• The severity of SAE

  The severity of SAE

  From Day 1(first dose) to Day12

• The Number of participants with SAE

  The Number of participants with SAE

  From Day 1(first dose) to Day12

• The severity ofclinical symptoms abnormalities(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）

  The severity ofclinical symptoms abnormalities(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）

  From Day 1(first dose) to Day12

• The Number of participantswith abnormal clinical symptoms(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）

  The Number of participantswith abnormal clinical symptoms(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）

  From Day 1(first dose) to Day12

• The severity of vital signs abnormalities

  The severity of Pulse abnormalities

  From Day 1(first dose) to Day12

• The Number of participantswith abnormal vital signs

  The Number of participantswith abnormal Pulse

  From Day 1(first dose) to Day12

• The severity of vital signs abnormalities

  The severity of blood pressure abnormalities

  From Day 1(first dose) to Day12

• The Number of participantswith abnormal vital signs

  The Number of participantswith abnormal blood pressure

  From Day 1(first dose) to Day12

• The severity of vital signs abnormalities

  The severity of respiration abnormalities

  From Day 1(first dose) to Day12

• The Number of participantswith abnormal vital signs

  The Number of participantswith abnormal respiration

  From Day 1(first dose) to Day12

• The severity of vital signs abnormalities

  The severity of body temperature abnormalities

  From Day 1(first dose) to Day12

• The Number of participantswith abnormal vital signs

  The Number of participantswith abnormal body temperature

  From Day 1(first dose) to Day12

• The severity of vital signs abnormalities

  The severity of abnormal physical examinations findings

  From Day 1(first dose) to Day12

• The Number of participantswith abnormal physical examinations findings

  The Number of participantswith abnormal physical examinations findings

  From Day 1(first dose) to Day12

• The severity of abnormal laboratory tests results

  The severity of abnormal laboratory tests results

  From Day 1(first dose) to Day12

• The Number of participantswith abnormal laboratory tests results

  The Number of participantswith abnormal laboratory tests results

  From Day 1(first dose) to Day12

• The severity of electrocardiogram (ECG) abnormalities

  The severity of Heart rate abnormalities

  From Day 1(first dose) to Day7

• The Number of participants with electrocardiogram (ECG) abnormalities

  The Number of participants with Heart rate abnormalities

  From Day 1(first dose) to Day7

• The severity of electrocardiogram (ECG) abnormalities

  The severity of PR interval abnormalities

  From Day 1(first dose) to Day7

• The Number of participants with electrocardiogram (ECG) abnormalities

  The Number of participants with PR interval abnormalities

  From Day 1(first dose) to Day7

• The severity of electrocardiogram (ECG) abnormalities

  The severity of QRS interval abnormalities

  From Day 1(first dose) to Day7

• The Number of participants with electrocardiogram (ECG) abnormalities

  The Number of participants with QRS interval abnormalities

  From Day 1(first dose) to Day7

• The severity of electrocardiogram (ECG) abnormalities

  The severity of QT interval abnormalities

  From Day 1(first dose) to Day7

• The Number of participants with electrocardiogram (ECG) abnormalities

  The Number of participants with QT interval abnormalities

  From Day 1(first dose) to Day7

• The severity of electrocardiogram (ECG) abnormalities

  The severity of QTcF abnormalities

  From Day 1(first dose) to Day7

• The Number of participants with electrocardiogram (ECG) abnormalities

  The Number of participants with QTcF abnormalities

  From Day 1(first dose) to Day7

Secondary Outcomes (3)

• The Cmax of the main metabolite 116-N1 of JT001;

  Day 1/Day 5 and Day 6 after first dose

• The AUC0-t of the main metabolite 116-N1 of JT001;

  Day 1/Day 5 and Day 6 after first dose

• The AUC0-inf of the main metabolite 116-N1 of JT001;

  Day 1/Day 5 and Day 6 after first dose

Other Outcomes (1)

• The steady-state trough concentration of therapeutic drug monitoring (TDM) for the basic medication of the subjects.

  Day 2 and Day 1before first dose and Day 6/Day 7/Day 8 after first dose

Study Arms (1)

Elderly subjects

EXPERIMENTAL

elderly subjects with underlying diseases.

Drug: Deuremidevir Hydrobromide Tablets

Interventions

Deuremidevir Hydrobromide Tablets DRUG

Multiple administration, oral administration after meals, D1: 0.6g, twice a day; D2-D5: 0.3g, twice a day; D6: 0.3g, administered once in the morning

Also known as: JT001

Elderly subjects

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 60 years old, regardless of gender;
• Weight: Male ≥ 50 kg, female ≥ 45 kg; Body mass index (BMI) within the range of 18-30 kg/m2 (including 18 and 30);
• Subjects suffer from chronic basic diseases and have stable disease control (such as well controlled hypertension, hyperlipidemia, diabetes, etc.);
• At least 2 weeks before enrollment, the treatment plan for chronic underlying diseases of the subjects has not been adjusted, and the usage, dosage, and duration of the treatment drugs remain unchanged;
• During the study period, the subjects were willing to discontinue non essential concomitant medications or health products (excluding essential treatment drugs for chronic underlying diseases of the subjects, and the specific drugs and health products were determined by the researchers and specialist doctors in consultation);
• The results of vital signs, physical examinations, routine laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function, etc.), 12-lead electrocardiogram, chest X-ray, abdominal ultrasound, etc. are normal or abnormal, but the researchers determine that they are related to age and chronic diseases. After enrollment, the safety risk of the subjects is low and does not affect the study observation indicators;
• Those who understand the research procedures and methods, voluntarily participate in this study, and sign an informed consent form in writing.

You may not qualify if:

• Individuals with a known history of allergies, allergic diseases, or allergic constitutions to the research formulation, any of its components, or related preparations;
• Any surgical situation or condition that may significantly affect the absorption, distribution, metabolism, and excretion of drugs, or any surgical situation or condition that may pose a hazard to the participants in the study, such as a history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), a history of gastroenteritis, gastrointestinal ulcers, gastrointestinal bleeding, history of malignant tumors, etc. (excluding cholecystectomy);
• Those who have experienced the following conditions within 3 months prior to the administration of the study drug: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, congestive heart failure, severe arrhythmia, cerebrovascular accidents, including transient ischemic attacks;
• Individuals who have experienced blood loss of ≥ 400 mL within the first 3 months of enrollment;
• Individuals who have participated in clinical research on other drugs or medical devices within the first 3 months of being selected;
• Drink alcohol at least twice a day or more than 14 times a week within 6 months before selection, or indulge in excessive drinking (one drink is defined as 125 mL of wine, 220 mL of beer or 50 mL of Baijiu; excessive drinking is defined as five or more drinks within about 2 hours);
• Individuals with a history of drug use or positive drug abuse screening;
• Those who smoke more than 10 cigarettes per day within the first 6 months of enrollment;
• Positive individuals for hepatitis B surface antigen (HBsAg), HCV antibody, Treponema pallidum antibody, and HIV antibody;
• Researchers believe that there are other factors that are not suitable for participating in the study.

Sponsors & Collaborators

• Shanghai Vinnerna Biosciences Co., Ltd.: lead
• Sponsor GmbH: collaborator

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, China

Location

MeSH Terms

Interventions

GS-621763

Study Officials

• Huiyu Lan, Project Director

  Shanghai Vinnerna Biosciences Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 23, 2023
• Study Start: July 12, 2023
• Primary Completion: August 25, 2023
• Study Completion: August 25, 2023
• Last Updated: October 23, 2023

Record last verified: 2023-09

Locations

CN (1)