A Study in Elderly Chinese Subjects With Underlying Diseases

A Phase 1, Open-label, Single-and Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of JT001 Administered Orally in Elderly Chinese Subjects With Underlying Diseases

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.

Study Overview

• Status: Completed
• Conditions: Elderly Subjects With Underlying Diseases
• Intervention / Treatment: Drug: Deuremidevir Hydrobromide Tablets

Detailed Description

The open-label, single-center phase I study to evaluate the safety, tolerability, and pharmacokinetics of JT001 single-and multiple-dose administered orally in elderly subjects with underlying diseases.Approximately 16 to 18 elderly subjects will be enrolled aging beyound 60 years.

All subjects received JT001, 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.Blood samples will be collected at times sufficient to adequately define the pharmacokinetics of JT001 active metabolite(116N-1) in elderly groups.The steady-state trough concentration of therapeutic drug monitoring (TDM) for the basic medication of the subjects will be collected as well.

Subjects will be admitted to the phase I clinical trial ward 2 days before administration (D-2) and will not be allowed to leave until all examinations and assessments are completed on day 8. Telephone follow-up will be performed on day 12 (±1 day).

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200031
      • Shanghai Xuhui Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 60 years old, regardless of gender;
2. Weight: Male ≥ 50 kg, female ≥ 45 kg; Body mass index (BMI) within the range of 18-30 kg/m2 (including 18 and 30);
3. Subjects suffer from chronic basic diseases and have stable disease control (such as well controlled hypertension, hyperlipidemia, diabetes, etc.);
4. 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;
5. 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);
6. 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;
7. Those who understand the research procedures and methods, voluntarily participate in this study, and sign an informed consent form in writing.

Exclusion Criteria:

1. Individuals with a known history of allergies, allergic diseases, or allergic constitutions to the research formulation, any of its components, or related preparations;
2. 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);
3. 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;
4. Individuals who have experienced blood loss of ≥ 400 mL within the first 3 months of enrollment;
5. Individuals who have participated in clinical research on other drugs or medical devices within the first 3 months of being selected;
6. 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);
7. Individuals with a history of drug use or positive drug abuse screening;
8. Those who smoke more than 10 cigarettes per day within the first 6 months of enrollment;
9. Positive individuals for hepatitis B surface antigen (HBsAg), HCV antibody, Treponema pallidum antibody, and HIV antibody;
10. Researchers believe that there are other factors that are not suitable for participating in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elderly subjects; elderly subjects with underlying diseases.	Drug: Deuremidevir Hydrobromide Tablets; 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; Other Names: JT001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Cmax of the main metabolite 116-N1 of JT001;	area under curve from time zero to infinity	Day 1/Day 5 and Day 6 after first dose
The AUC0-t of the main metabolite 116-N1 of JT001;	area under curve from time zero to infinity	Day 1/Day 5 and Day 6 after first dose
The AUC0-inf of the main metabolite 116-N1 of JT001;	area under curve from time zero to infinity	Day 1/Day 5 and Day 6 after first dose

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The steady-state trough concentration of therapeutic drug monitoring (TDM) for the basic medication of the subjects.	The steady-state trough concentration of therapeutic drug monitoring (TDM)	Day 2 and Day 1before first dose and Day 6/Day 7/Day 8 after first dose

Collaborators and Investigators

• Sponsor: Shanghai Vinnerna Biosciences Co., Ltd.
• Collaborators: Sponsor GmbH
• Investigators: Study Director: Huiyu Lan, Project Director, Shanghai Vinnerna Biosciences Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2023
• Primary Completion (Actual): August 25, 2023
• Study Completion (Actual): August 25, 2023

Study Registration Dates

• First Submitted: September 25, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: JT001-017-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No