Elderly Subjects With Underlying DiseasesPhase 1NCT06093308
A Study in Elderly Chinese Subjects With Underlying Diseases
A Phase 1 study testing Deuremidevir Hydrobromide Tablets in people with Elderly Subjects With Underlying Diseases, run by Shanghai Vinnerna Biosciences Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly Subjects With Underlying Diseases
- What is being tested?
- Deuremidevir Hydrobromide Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 12 Jul 2023to 25 Aug 2023
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200031
About this study
Official title: 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.
Read the 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).
- Being tested
- Deuremidevir Hydrobromide Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deuremidevir Hydrobromide TabletsDrug
Also called JT001
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
| Study group | Role | What they receive |
|---|---|---|
| Elderly subjects | Experimental | elderly subjects with underlying diseases. Receives: Drug: Deuremidevir Hydrobromide Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of SAE
The severity of SAE
Measured: From Day 1(first dose) to Day12
The Number of participants with SAE
The Number of participants with SAE
Measured: 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）
Measured: 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）
Measured: From Day 1(first dose) to Day12
The severity of vital signs abnormalities
The severity of Pulse abnormalities
Measured: From Day 1(first dose) to Day12
The Number of participantswith abnormal vital signs
The Number of participantswith abnormal Pulse
Measured: From Day 1(first dose) to Day12
The severity of vital signs abnormalities
The severity of blood pressure abnormalities
Measured: From Day 1(first dose) to Day12
The Number of participantswith abnormal vital signs
The Number of participantswith abnormal blood pressure
Measured: From Day 1(first dose) to Day12
The severity of vital signs abnormalities
The severity of respiration abnormalities
Measured: From Day 1(first dose) to Day12
The Number of participantswith abnormal vital signs
The Number of participantswith abnormal respiration
Measured: From Day 1(first dose) to Day12
The severity of vital signs abnormalities
The severity of body temperature abnormalities
Measured: From Day 1(first dose) to Day12
The Number of participantswith abnormal vital signs
The Number of participantswith abnormal body temperature
Measured: From Day 1(first dose) to Day12
The severity of vital signs abnormalities
The severity of abnormal physical examinations findings
Measured: From Day 1(first dose) to Day12
The Number of participantswith abnormal physical examinations findings
The Number of participantswith abnormal physical examinations findings
Measured: From Day 1(first dose) to Day12
The severity of abnormal laboratory tests results
The severity of abnormal laboratory tests results
Measured: From Day 1(first dose) to Day12
The Number of participantswith abnormal laboratory tests results
The Number of participantswith abnormal laboratory tests results
Measured: From Day 1(first dose) to Day12
The severity of electrocardiogram (ECG) abnormalities
The severity of Heart rate abnormalities
Measured: From Day 1(first dose) to Day7
The Number of participants with electrocardiogram (ECG) abnormalities
The Number of participants with Heart rate abnormalities
Measured: From Day 1(first dose) to Day7
The severity of electrocardiogram (ECG) abnormalities
The severity of PR interval abnormalities
Measured: From Day 1(first dose) to Day7
The Number of participants with electrocardiogram (ECG) abnormalities
The Number of participants with PR interval abnormalities
Measured: From Day 1(first dose) to Day7
The severity of electrocardiogram (ECG) abnormalities
The severity of QRS interval abnormalities
Measured: From Day 1(first dose) to Day7
The Number of participants with electrocardiogram (ECG) abnormalities
The Number of participants with QRS interval abnormalities
Measured: From Day 1(first dose) to Day7
The severity of electrocardiogram (ECG) abnormalities
The severity of QT interval abnormalities
Measured: From Day 1(first dose) to Day7
The Number of participants with electrocardiogram (ECG) abnormalities
The Number of participants with QT interval abnormalities
Measured: From Day 1(first dose) to Day7
The severity of electrocardiogram (ECG) abnormalities
The severity of QTcF abnormalities
Measured: From Day 1(first dose) to Day7
The Number of participants with electrocardiogram (ECG) abnormalities
The Number of participants with QTcF abnormalities
Measured: From Day 1(first dose) to Day7
Secondary outcomes (3)
The Cmax of the main metabolite 116-N1 of JT001;
area under curve from time zero to infinity
Measured: 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
Measured: 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
Measured: Day 1/Day 5 and Day 6 after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start12 Jul 2023
- Primary completion25 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly Subjects With Underlying DiseasesStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Vinnerna Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sponsor GmbH
- Responsible party
- Sponsor
- Investigators
- Huiyu Lan, Project Director, Study director, Shanghai Vinnerna Biosciences Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093308
- Sponsor's protocol ID
- JT001-017-I
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06093308
- Acronym / sponsor ID
- JT001-017-I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Shanghai Vinnerna Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sponsor GmbH
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 23 Oct 2023 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly subjects | Experimental | Drug: Deuremidevir Hydrobromide Tabletselderly subjects with underlying diseases. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (10 listed)
- 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;
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 |
|---|---|---|
| Deuremidevir Hydrobromide TabletsAlso: JT001Multiple 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 | Drug | Elderly subjects |
Primary outcome
The severity of SAE
Time frame: From Day 1(first dose) to Day12
The severity of SAE
The Number of participants with SAE
Time frame: From Day 1(first dose) to Day12
The Number of participants with SAE
The severity ofclinical symptoms abnormalities(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）
Time frame: From Day 1(first dose) to Day12
The severity ofclinical symptoms abnormalities(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）
Time frame: From Day 1(first dose) to Day12
The Number of participantswith abnormal clinical symptoms(e.g.,Dizziness, headache, nausea, abdominal pain, fatigue, drowsiness）
The severity of vital signs abnormalities
Time frame: From Day 1(first dose) to Day12
The severity of Pulse abnormalities
The Number of participantswith abnormal vital signs
Time frame: From Day 1(first dose) to Day12
The Number of participantswith abnormal Pulse
The severity of vital signs abnormalities
Time frame: From Day 1(first dose) to Day12
The severity of blood pressure abnormalities
The Number of participantswith abnormal vital signs
Time frame: From Day 1(first dose) to Day12
The Number of participantswith abnormal blood pressure
The severity of vital signs abnormalities
Time frame: From Day 1(first dose) to Day12
The severity of respiration abnormalities
The Number of participantswith abnormal vital signs
Time frame: From Day 1(first dose) to Day12
The Number of participantswith abnormal respiration
The severity of vital signs abnormalities
Time frame: From Day 1(first dose) to Day12
The severity of body temperature abnormalities
The Number of participantswith abnormal vital signs
Time frame: From Day 1(first dose) to Day12
The Number of participantswith abnormal body temperature
The severity of vital signs abnormalities
Time frame: From Day 1(first dose) to Day12
The severity of abnormal physical examinations findings
The Number of participantswith abnormal physical examinations findings
Time frame: From Day 1(first dose) to Day12
The Number of participantswith abnormal physical examinations findings
The severity of abnormal laboratory tests results
Time frame: From Day 1(first dose) to Day12
The severity of abnormal laboratory tests results
The Number of participantswith abnormal laboratory tests results
Time frame: From Day 1(first dose) to Day12
The Number of participantswith abnormal laboratory tests results
The severity of electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The severity of Heart rate abnormalities
The Number of participants with electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The Number of participants with Heart rate abnormalities
The severity of electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The severity of PR interval abnormalities
The Number of participants with electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The Number of participants with PR interval abnormalities
The severity of electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The severity of QRS interval abnormalities
The Number of participants with electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The Number of participants with QRS interval abnormalities
The severity of electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The severity of QT interval abnormalities
The Number of participants with electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The Number of participants with QT interval abnormalities
The severity of electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The severity of QTcF abnormalities
The Number of participants with electrocardiogram (ECG) abnormalities
Time frame: From Day 1(first dose) to Day7
The Number of participants with QTcF abnormalities
3 secondary outcomes
The Cmax of the main metabolite 116-N1 of JT001;
Time frame: Day 1/Day 5 and Day 6 after first dose
The AUC0-t of the main metabolite 116-N1 of JT001;
Time frame: Day 1/Day 5 and Day 6 after first dose
The AUC0-inf of the main metabolite 116-N1 of JT001;
Time frame: Day 1/Day 5 and Day 6 after first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Undecided. Undecided
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.
Huiyu Lan, Project Director study director
Shanghai Vinnerna Biosciences Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Deuremidevir Hydrobromide Tablets in people with Elderly Subjects With Underlying Diseases, run by Shanghai Vinnerna Biosciences Co., Ltd. at 1 site in China.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The severity of SAE (time frame: From Day 1(first dose) to Day12). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2023.