Trial Outcomes & Findings for Efficacy and Safety of TJ0113 Capsule in Patients With Parkinson's Disease (NCT NCT06596005)
NCT ID: NCT06596005
Last Updated: 2026-01-16
Results Overview
The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts. In this study, the Part III score was designated as the primary efficacy endpoint.Part 3: Motor examination (18 items, some of which include multiple scorable components, resulting in a total of 33 scoreable entries, with an overall score ranging from 0 to 132).Higher values represent a worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
149 participants
Primary outcome timeframe
After 12 weeks.
Results posted on
2026-01-16
Participant Flow
Participant milestones
| Measure |
TJ0113 200mg
Subjects will receive 200 mg of TJ0113 capsules for 12 consecutive weeks
TJ0113 200mg: 200 mg Capsule, Once Daily
|
TJ0113 400mg
Subjects will receive 400 mg of TJ0113 capsules for 12 consecutive weeks
TJ0113 400mg: 400 mg Capsule, Once Daily
|
Placebo
Subjects will receive 200 mg or 400 mg of placebo for 12 consecutive weeks
Placebo: Capsule, Once Daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
48
|
51
|
|
Overall Study
COMPLETED
|
48
|
44
|
50
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
1
|
Reasons for withdrawal
| Measure |
TJ0113 200mg
Subjects will receive 200 mg of TJ0113 capsules for 12 consecutive weeks
TJ0113 200mg: 200 mg Capsule, Once Daily
|
TJ0113 400mg
Subjects will receive 400 mg of TJ0113 capsules for 12 consecutive weeks
TJ0113 400mg: 400 mg Capsule, Once Daily
|
Placebo
Subjects will receive 200 mg or 400 mg of placebo for 12 consecutive weeks
Placebo: Capsule, Once Daily
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
1
|
|
Overall Study
Other
|
0
|
2
|
0
|
Baseline Characteristics
Efficacy and Safety of TJ0113 Capsule in Patients With Parkinson's Disease
Baseline characteristics by cohort
| Measure |
TJ0113 400mg
n=48 Participants
Subjects will receive 400 mg of TJ0113 capsules for 12 consecutive weeks
TJ0113 400mg: 400 mg Capsule, Once Daily
|
Placebo
n=51 Participants
Subjects will receive 200 mg or 400 mg of placebo for 12 consecutive weeks
Placebo: Capsule, Once Daily
|
Total
n=149 Participants
Total of all reporting groups
|
TJ0113 200mg
n=50 Participants
Subjects will receive 200 mg of TJ0113 capsules for 12 consecutive weeks
TJ0113 200mg: 200 mg Capsule, Once Daily
|
|---|---|---|---|---|
|
Age, Continuous
|
59.9 years
STANDARD_DEVIATION 7.90 • n=6 Participants
|
60.3 years
STANDARD_DEVIATION 10.02 • n=9 Participants
|
60.0 years
STANDARD_DEVIATION 8.64 • n=205 Participants
|
59.8 years
STANDARD_DEVIATION 7.93 • n=9 Participants
|
|
Age, Customized
<18
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=9 Participants
|
|
Age, Customized
18-65
|
38 Participants
n=6 Participants
|
32 Participants
n=9 Participants
|
105 Participants
n=205 Participants
|
35 Participants
n=9 Participants
|
|
Age, Customized
66-75
|
10 Participants
n=6 Participants
|
17 Participants
n=9 Participants
|
42 Participants
n=205 Participants
|
15 Participants
n=9 Participants
|
|
Age, Customized
>75
|
0 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
2 Participants
n=205 Participants
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=6 Participants
|
19 Participants
n=9 Participants
|
65 Participants
n=205 Participants
|
21 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=6 Participants
|
32 Participants
n=9 Participants
|
84 Participants
n=205 Participants
|
29 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
48 Participants
n=6 Participants
|
51 Participants
n=9 Participants
|
149 Participants
n=205 Participants
|
50 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=205 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
China
|
48 participants
n=6 Participants
|
51 participants
n=9 Participants
|
149 participants
n=205 Participants
|
50 participants
n=9 Participants
|
|
MDS-UPDRS Score at Baseline(Part III)
|
46.8 units on a scale
STANDARD_DEVIATION 10.60 • n=6 Participants
|
45.1 units on a scale
STANDARD_DEVIATION 9.69 • n=9 Participants
|
46.3 units on a scale
STANDARD_DEVIATION 10.04 • n=205 Participants
|
47 units on a scale
STANDARD_DEVIATION 9.93 • n=9 Participants
|
PRIMARY outcome
Timeframe: After 12 weeks.The Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) rating tool was used to follow longitudinal course of Parkinson's Disease. It was made up of 4 parts. In this study, the Part III score was designated as the primary efficacy endpoint.Part 3: Motor examination (18 items, some of which include multiple scorable components, resulting in a total of 33 scoreable entries, with an overall score ranging from 0 to 132).Higher values represent a worse outcome.
Outcome measures
| Measure |
TJ0113 200mg
n=50 Participants
Subjects will receive 200 mg of TJ0113 capsules for 12 consecutive weeks
TJ0113 200mg: 200 mg Capsule, Once Daily
|
TJ0113 400mg
n=48 Participants
Subjects will receive 400 mg of TJ0113 capsules for 12 consecutive weeks
TJ0113 400mg: 400 mg Capsule, Once Daily
|
Placebo
n=51 Participants
Subjects will receive 200 mg or 400 mg of placebo for 12 consecutive weeks
Placebo: Capsule, Once Daily
|
|---|---|---|---|
|
Changes From Baseline in Scores of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination) in Subjects After 12 Weeks of Treatment.Evaluation Time Point: ≥ 12 Hours From the Most Recent Dose of Anti-PD Drug.
|
-7.06 score on a scale
Standard Error 0.703
|
-7.40 score on a scale
Standard Error 0.714
|
-0.69 score on a scale
Standard Error 0.686
|
Adverse Events
TJ0113 200mg
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
TJ0113 400mg
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TJ0113 200mg
n=50 participants at risk
Subjects will receive 200 mg of TJ0113 capsules for 12 consecutive weeks
TJ0113 200mg: 200 mg Capsule, Once Daily
|
TJ0113 400mg
n=48 participants at risk
Subjects will receive 400 mg of TJ0113 capsules for 12 consecutive weeks
TJ0113 400mg: 400 mg Capsule, Once Daily
|
Placebo
n=51 participants at risk
Subjects will receive 200 mg or 400 mg of placebo for 12 consecutive weeks
Placebo: Capsule, Once Daily
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
Other adverse events
| Measure |
TJ0113 200mg
n=50 participants at risk
Subjects will receive 200 mg of TJ0113 capsules for 12 consecutive weeks
TJ0113 200mg: 200 mg Capsule, Once Daily
|
TJ0113 400mg
n=48 participants at risk
Subjects will receive 400 mg of TJ0113 capsules for 12 consecutive weeks
TJ0113 400mg: 400 mg Capsule, Once Daily
|
Placebo
n=51 participants at risk
Subjects will receive 200 mg or 400 mg of placebo for 12 consecutive weeks
Placebo: Capsule, Once Daily
|
|---|---|---|---|
|
Investigations
White blood cell count decreased
|
4.0%
2/50 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
4.2%
2/48 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
5.9%
3/51 • Number of events 4 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Investigations
Aspartate aminotransferase increased
|
4.0%
2/50 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
5.9%
3/51 • Number of events 3 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Investigations
Alanine aminotransferase increased
|
4.0%
2/50 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
3.9%
2/51 • Number of events 3 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Investigations
Blood creatine phosphokinase increased
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
3.9%
2/51 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Investigations
Bile acids increased
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Investigations
Urinary occult blood positive
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
3.9%
2/51 • Number of events 3 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Investigations
White blood cells urine positive
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Investigations
Heart rate increased
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Investigations
Electrocardiogram T wave abnormal
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Investigations
Interleukin level increased
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Investigations
Platelet count decreased
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Investigations
Blood glucose increased
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Infections and infestations
Urinary tract infection
|
4.0%
2/50 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
6.2%
3/48 • Number of events 3 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
3.9%
2/51 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
3.9%
2/51 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Infections and infestations
Periodontitis
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
6.2%
3/48 • Number of events 3 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Infections and infestations
Conjunctivitis
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Infections and infestations
Pharyngitis
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Infections and infestations
Viral infection
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
4.2%
2/48 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Gastrointestinal disorders
Abdominal distension
|
4.0%
2/50 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
4.2%
2/48 • Number of events 3 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Gastrointestinal disorders
Chronic gastritis
|
2.0%
1/50 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
4.2%
2/48 • Number of events 3 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Nervous system disorders
Headache
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
4.2%
2/48 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Nervous system disorders
Dyskinesia
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
4.2%
2/48 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
4.0%
2/50 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.0%
3/50 • Number of events 3 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
3.9%
2/51 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
General disorders
Chest discomfort
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 2 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
General disorders
Pain
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Psychiatric disorders
Rapid eye movements sleep abnormal
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.0%
1/51 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.0%
1/50 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/48 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/50 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
2.1%
1/48 • Number of events 1 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
0.00%
0/51 • AEs are collected in this trial from the time the subject receives the investigational product (i.e., TJ0113 capsules or placebo) until the end of the follow-up period.(From enrollment to end of treatment at 13 weeks.)
|
Additional Information
Director of Clinical Trials
Hangzhou PhecdaMed Co., Ltd.
Phone: +86 18626868383
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place