Trial Outcomes & Findings for A Study to Investigate the Effects of CBP-307 on the Heart Rate-corrected QT Interval (QTc) in Healthy Subjects (NCT NCT04818229)
NCT ID: NCT04818229
Last Updated: 2024-11-04
Results Overview
Change from Baseline in QT interval corrected for heart rate using Fridericia's method (QTcF) to evaluate the effects of therapeutic and supratherapeutic CBP-307 plasma concentrations.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
112 participants
Primary outcome timeframe
From Baseline to Day 16
Results posted on
2024-11-04
Participant Flow
Placebo was administered to all subjects on Day -1, and assigned study treatments were administered on Days 1 through 16.
Participant milestones
| Measure |
Investigational Group 1
In Group 1, subjects received a starting dose of 0.05 mg CBP-307 on Day 1 followed by an up-titrated dose of 0.1 mg on Day 2 and a dose of 0.2 mg on Days 3 to 6 in order to achieve a therapeutic dose on Day 6. Dose administration continued with a dose of 0.5 mg CBP-307 on Days 7 to 15 in order to achieve a supratherapeutic dose on Day 15. CBP-307 and moxifloxacin placebo were administered on Day 16.
|
Investigational Group 2A
In Group 2A, 400 mg moxifloxacin was administered on Day 1, with CBP-307 or moxifloxacin placebo administered on all other days.
|
Investigational Group 2B
In Group 2B, 400 mg moxifloxacin was administered on Day 16, with CBP-307 or moxifloxacin placebo administered on all other days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
55
|
28
|
29
|
|
Overall Study
COMPLETED
|
32
|
17
|
15
|
|
Overall Study
NOT COMPLETED
|
23
|
11
|
14
|
Reasons for withdrawal
| Measure |
Investigational Group 1
In Group 1, subjects received a starting dose of 0.05 mg CBP-307 on Day 1 followed by an up-titrated dose of 0.1 mg on Day 2 and a dose of 0.2 mg on Days 3 to 6 in order to achieve a therapeutic dose on Day 6. Dose administration continued with a dose of 0.5 mg CBP-307 on Days 7 to 15 in order to achieve a supratherapeutic dose on Day 15. CBP-307 and moxifloxacin placebo were administered on Day 16.
|
Investigational Group 2A
In Group 2A, 400 mg moxifloxacin was administered on Day 1, with CBP-307 or moxifloxacin placebo administered on all other days.
|
Investigational Group 2B
In Group 2B, 400 mg moxifloxacin was administered on Day 16, with CBP-307 or moxifloxacin placebo administered on all other days.
|
|---|---|---|---|
|
Overall Study
The cohort was canceled due to COVID-19
|
20
|
10
|
10
|
|
Overall Study
Adverse Event
|
3
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Investigate the Effects of CBP-307 on the Heart Rate-corrected QT Interval (QTc) in Healthy Subjects
Baseline characteristics by cohort
| Measure |
Investigational Group 1
n=55 Participants
Therapeutic and supratherapeutic multiple oral doses of CBP-307.
CBP-307: CBP-307 capsules oral administration.
Placebo-matched CBP-307: Placebo-matched CBP-307 capsules oral administration.
|
Investigational Group 2A
n=28 Participants
Moxifloxacin (positive control for method validation) and Placebo oral administration.
Moxifloxacin (Avelox): Moxifloxacin tablets oral administration。
Placebo-matched Moxifloxacin: Placebo-matched Moxifloxacin tablets oral administration.
|
Investigational Group 2B
n=29 Participants
Moxifloxacin (positive control for method validation) and Placebo oral administration.
Moxifloxacin (Avelox): Moxifloxacin tablets oral administration。
Placebo-matched Moxifloxacin: Placebo-matched Moxifloxacin tablets oral administration.
|
Total
n=112 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 11.17 • n=5 Participants
|
41.6 years
STANDARD_DEVIATION 11.25 • n=7 Participants
|
41.1 years
STANDARD_DEVIATION 11.10 • n=5 Participants
|
41.6 years
STANDARD_DEVIATION 11.07 • n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
45 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
93 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Height
|
169.13 cm
STANDARD_DEVIATION 10.712 • n=5 Participants
|
168.45 cm
STANDARD_DEVIATION 8.960 • n=7 Participants
|
168.14 cm
STANDARD_DEVIATION 9.821 • n=5 Participants
|
168.71 cm
STANDARD_DEVIATION 9.994 • n=4 Participants
|
|
Body Weight
|
76.80 Kg
STANDARD_DEVIATION 12.481 • n=5 Participants
|
76.70 Kg
STANDARD_DEVIATION 10.636 • n=7 Participants
|
76.39 Kg
STANDARD_DEVIATION 10.890 • n=5 Participants
|
76.67 Kg
STANDARD_DEVIATION 11.543 • n=4 Participants
|
|
Body Mass Index
|
26.74 kg/m^2
STANDARD_DEVIATION 2.656 • n=5 Participants
|
26.95 kg/m^2
STANDARD_DEVIATION 2.423 • n=7 Participants
|
27.01 kg/m^2
STANDARD_DEVIATION 2.866 • n=5 Participants
|
26.87 kg/m^2
STANDARD_DEVIATION 2.636 • n=4 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Day 16Population: Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B).
Change from Baseline in QT interval corrected for heart rate using Fridericia's method (QTcF) to evaluate the effects of therapeutic and supratherapeutic CBP-307 plasma concentrations.
Outcome measures
| Measure |
Investigational Group 1
n=32 Participants
0.5 mg CBP-307 on Day 15 at 24 hours Post-dose.
|
Investigational Group 2A+2B
n=33 Participants
Placebo on Day 15 at 24 hours Post-dose.
|
|---|---|---|
|
Change-from-baseline QT Interval Corrected for Heart Rate Using Fridericia's Method (QTcF)
|
1.5 msec
Standard Error 2.46
|
0.9 msec
Standard Error 2.40
|
SECONDARY outcome
Timeframe: From Baseline at Day 16Population: Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B).
Change from Baseline in heart rate (HR).
Outcome measures
| Measure |
Investigational Group 1
n=32 Participants
0.5 mg CBP-307 on Day 15 at 24 hours Post-dose.
|
Investigational Group 2A+2B
n=33 Participants
Placebo on Day 15 at 24 hours Post-dose.
|
|---|---|---|
|
Change-from-baseline Heart Rate (HR)
|
-3.2 beats/min
Standard Error 0.98
|
-1.3 beats/min
Standard Error 0.96
|
SECONDARY outcome
Timeframe: From Baseline at Day 16Population: Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B).
Change from Baseline in PR.
Outcome measures
| Measure |
Investigational Group 1
n=32 Participants
0.5 mg CBP-307 on Day 15 at 24 hours Post-dose.
|
Investigational Group 2A+2B
n=33 Participants
Placebo on Day 15 at 24 hours Post-dose.
|
|---|---|---|
|
Change-from-baseline PR
|
4.5 msec
Standard Error 2.58
|
-0.3 msec
Standard Error 2.51
|
SECONDARY outcome
Timeframe: From Baseline at Day 16Population: Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B).
Change from Baseline in QRS.
Outcome measures
| Measure |
Investigational Group 1
n=32 Participants
0.5 mg CBP-307 on Day 15 at 24 hours Post-dose.
|
Investigational Group 2A+2B
n=33 Participants
Placebo on Day 15 at 24 hours Post-dose.
|
|---|---|---|
|
Change-from-baseline QRS
|
0.1 msec
Standard Error 0.84
|
-0.5 msec
Standard Error 0.81
|
SECONDARY outcome
Timeframe: From Baseline to Day 16Population: Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B).
Placebo-corrected Change-from-baseline HR based on Change-from-baseline Heart Rate (HR) reported in Outcome Measure 2
Outcome measures
| Measure |
Investigational Group 1
n=32 Participants
0.5 mg CBP-307 on Day 15 at 24 hours Post-dose.
|
Investigational Group 2A+2B
Placebo on Day 15 at 24 hours Post-dose.
|
|---|---|---|
|
Placebo-corrected Change-from-baseline HR
|
-1.9 beats/min
Standard Error 1.37
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Day 16Population: Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B).
Placebo-corrected change-from-baseline QT Interval Corrected for Heart Rate Using Fridericia's Method (QTcF) based on Change-from-baseline QTcF reported in Outcome Measure 1
Outcome measures
| Measure |
Investigational Group 1
n=32 Participants
0.5 mg CBP-307 on Day 15 at 24 hours Post-dose.
|
Investigational Group 2A+2B
Placebo on Day 15 at 24 hours Post-dose.
|
|---|---|---|
|
Placebo-corrected Change-from-baseline QTcF
|
0.6 msec
Standard Error 3.44
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Day 16Population: Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B).
Placebo-corrected change-from-baseline PR based on Change-from-baseline PR reported in Outcome Measure 3
Outcome measures
| Measure |
Investigational Group 1
n=32 Participants
0.5 mg CBP-307 on Day 15 at 24 hours Post-dose.
|
Investigational Group 2A+2B
Placebo on Day 15 at 24 hours Post-dose.
|
|---|---|---|
|
Placebo-corrected Change-from-baseline PR
|
4.8 msec
Standard Error 3.60
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Day 16Population: Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B).
Placebo-corrected change-from-baseline QRS based on Change-from-baseline QRS reported in Outcome Measure 4
Outcome measures
| Measure |
Investigational Group 1
n=32 Participants
0.5 mg CBP-307 on Day 15 at 24 hours Post-dose.
|
Investigational Group 2A+2B
Placebo on Day 15 at 24 hours Post-dose.
|
|---|---|---|
|
Placebo-corrected Change-from-baseline QRS
|
0.6 msec
Standard Error 1.17
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Day 16Population: Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B).
For categorical outliers, the number (percentage) of subjects as well as timepoints who had increases in absolute QTcF values \>450 and ≤480 msec, \>480 and ≤500 msec, or \>500 msec, and changes from predose baseline of \>30 and ≤60 msec, or \>60 msec.
Outcome measures
| Measure |
Investigational Group 1
n=32 Participants
0.5 mg CBP-307 on Day 15 at 24 hours Post-dose.
|
Investigational Group 2A+2B
n=56 Participants
Placebo on Day 15 at 24 hours Post-dose.
|
|---|---|---|
|
Categorical Outliers for QTcF
QTcF >450 and ≤480 msec
|
1 Participants
|
3 Participants
|
|
Categorical Outliers for QTcF
QTcF > 480 and ≤500 ms
|
0 Participants
|
0 Participants
|
|
Categorical Outliers for QTcF
QTcF > 500 ms
|
0 Participants
|
0 Participants
|
|
Categorical Outliers for QTcF
Change-from-baseline QTcF >30 and ≤60 ms
|
1 Participants
|
2 Participants
|
|
Categorical Outliers for QTcF
Change-from-baseline QTcF >60 ms
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Baseline to Day 16Population: Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B).
For categorical outliers, decrease in HR from predose baseline \>25% to an HR \<50 bpm will be determined.
Outcome measures
| Measure |
Investigational Group 1
n=32 Participants
0.5 mg CBP-307 on Day 15 at 24 hours Post-dose.
|
Investigational Group 2A+2B
n=56 Participants
Placebo on Day 15 at 24 hours Post-dose.
|
|---|---|---|
|
Categorical Outliers for HR
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Baseline to Day 16Population: Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B).
For categorical outliers, increase in PR from predose baseline \>25% to a PR \> 200 msec will be determined.
Outcome measures
| Measure |
Investigational Group 1
n=32 Participants
0.5 mg CBP-307 on Day 15 at 24 hours Post-dose.
|
Investigational Group 2A+2B
n=56 Participants
Placebo on Day 15 at 24 hours Post-dose.
|
|---|---|---|
|
Categorical Outliers for PR
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline to Day 16Population: Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B).
For categorical outliers, increase in QRS from predose baseline \>25% to a QRS \>120 msec will be determined.
Outcome measures
| Measure |
Investigational Group 1
n=32 Participants
0.5 mg CBP-307 on Day 15 at 24 hours Post-dose.
|
Investigational Group 2A+2B
n=56 Participants
Placebo on Day 15 at 24 hours Post-dose.
|
|---|---|---|
|
Categorical Outliers for QRS
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline to Day 16Population: Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B).
For T-wave morphology, the analyses will be focused on change from baseline with counts (percentages) for both the number of subjects and the number of timepoints.
Outcome measures
| Measure |
Investigational Group 1
n=32 Participants
0.5 mg CBP-307 on Day 15 at 24 hours Post-dose.
|
Investigational Group 2A+2B
n=56 Participants
Placebo on Day 15 at 24 hours Post-dose.
|
|---|---|---|
|
Frequency of Treatment-emergent Changes of T-wave Morphology
Flat
|
0 Participants
|
2 Participants
|
|
Frequency of Treatment-emergent Changes of T-wave Morphology
Notched (+)
|
0 Participants
|
0 Participants
|
|
Frequency of Treatment-emergent Changes of T-wave Morphology
Biphasic
|
0 Participants
|
2 Participants
|
|
Frequency of Treatment-emergent Changes of T-wave Morphology
Normal (-)
|
0 Participants
|
0 Participants
|
|
Frequency of Treatment-emergent Changes of T-wave Morphology
Notched (-)
|
0 Participants
|
0 Participants
|
|
Frequency of Treatment-emergent Changes of T-wave Morphology
Inverted
|
1 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: From Baseline to Day 16Population: Per protocol, approximately 68 healthy subjects (at least 30% for each sex) will be randomized into 2 groups (Group 1 and 2) with 34 subjects in each. Group 2 consists of 2 sub-groups (Group 2A and 2B) and each sub-group will be randomized with 17 subjects. That is to say, the placebo group is consist of Group 2A+Group 2B. The aim is to assess the ECG effect of CBP-307 versus placebo (CBP-307 in Group 1 versus placebo in Groups 2A and 2B).
For U-wave presence, the analyses will be focused on change from baseline with counts (percentages) for both the number of subjects and the number of timepoints.
Outcome measures
| Measure |
Investigational Group 1
n=32 Participants
0.5 mg CBP-307 on Day 15 at 24 hours Post-dose.
|
Investigational Group 2A+2B
n=56 Participants
Placebo on Day 15 at 24 hours Post-dose.
|
|---|---|---|
|
Frequency of Treatment-emergent Changes of U-wave Presence
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Baseline to Day 29 ± 2Population: Only subjects in Group 1 received CBP-307.
Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) will be analyzed as a pharmacokinetic (PK) parameter.
Outcome measures
| Measure |
Investigational Group 1
n=44 Participants
0.5 mg CBP-307 on Day 15 at 24 hours Post-dose.
|
Investigational Group 2A+2B
Placebo on Day 15 at 24 hours Post-dose.
|
|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUCinf)
|
543 h*ng/mL
Geometric Coefficient of Variation 24.4
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Day 29 ± 2Population: Only subjects in Group 1 received CBP-307.
Area under the concentration-time curve from time zero to 24 hours postdose (AUC0-24) will be analyzed as a pharmacokinetic (PK) parameter.
Outcome measures
| Measure |
Investigational Group 1
n=44 Participants
0.5 mg CBP-307 on Day 15 at 24 hours Post-dose.
|
Investigational Group 2A+2B
Placebo on Day 15 at 24 hours Post-dose.
|
|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to 24 Hours Postdose (AUC0-24)
|
237 h*ng/mL
Geometric Coefficient of Variation 21.8
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Day 29 ± 2Population: Only subjects in Group 1 received CBP-307.
Maximum observed concentration (Cmax) will be analyzed as a pharmacokinetic (PK) parameter.
Outcome measures
| Measure |
Investigational Group 1
n=44 Participants
0.5 mg CBP-307 on Day 15 at 24 hours Post-dose.
|
Investigational Group 2A+2B
Placebo on Day 15 at 24 hours Post-dose.
|
|---|---|---|
|
Maximum Observed Concentration (Cmax)
|
13.5 ng/mL
Geometric Coefficient of Variation 22.0
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Day 29 ± 2Population: Only subjects in Group 1 received CBP-307.
Time of the maximum observed concentration (tmax) will be analyzed as a pharmacokinetic (PK) parameter.
Outcome measures
| Measure |
Investigational Group 1
n=44 Participants
0.5 mg CBP-307 on Day 15 at 24 hours Post-dose.
|
Investigational Group 2A+2B
Placebo on Day 15 at 24 hours Post-dose.
|
|---|---|---|
|
Time of the Maximum Observed Concentration (Tmax)
|
3.02 h
Interval 1.02 to 8.0
|
—
|
SECONDARY outcome
Timeframe: From Baseline to Day 29 ± 2Population: Only subjects in Group 1 received CBP-307.
All AEs will be listed and treatment-emergent AEs will be summarized using the descriptive methodology. 14.3.1.1 TEAE
Outcome measures
| Measure |
Investigational Group 1
n=50 Participants
0.5 mg CBP-307 on Day 15 at 24 hours Post-dose.
|
Investigational Group 2A+2B
Placebo on Day 15 at 24 hours Post-dose.
|
|---|---|---|
|
Incidence and Severity of Adverse Event (AE)
Overall
|
12 participants
|
—
|
|
Incidence and Severity of Adverse Event (AE)
Serious
|
0 participants
|
—
|
|
Incidence and Severity of Adverse Event (AE)
Leading to Discontinuation
|
1 participants
|
—
|
|
Incidence and Severity of Adverse Event (AE)
Leading to Death
|
0 participants
|
—
|
Adverse Events
0.05 mg CBP-307
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
0.1 mg CBP-307
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
0.2 mg CBP-307
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
0.5 mg CBP-307
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Investigational Group 1
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Investigational Group 2A+2B
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.05 mg CBP-307
n=55 participants at risk
0.05 mg CBP-307 on Day 1
|
0.1 mg CBP-307
n=55 participants at risk
0.1 mg on Day 2
|
0.2 mg CBP-307
n=55 participants at risk
0.2 mg on Days 3 to 6
|
0.5 mg CBP-307
n=50 participants at risk
0.5 mg CBP-307 on Days 7 to 15
|
Investigational Group 1
n=55 participants at risk
Therapeutic and supratherapeutic multiple oral doses of CBP-307.
CBP-307: CBP-307 capsules oral administration.
Placebo-matched CBP-307: Placebo-matched CBP-307 capsules oral administration.
|
Investigational Group 2A+2B
n=57 participants at risk
Moxifloxacin (positive control for method validation) and Placebo oral administration.
Moxifloxacin (Avelox): Moxifloxacin tablets oral administration。
Placebo-matched Moxifloxacin: Placebo-matched Moxifloxacin tablets oral administration.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
7.3%
4/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
10.0%
5/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
16.4%
9/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
19.3%
11/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
General disorders
Catheter site pain
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
7.0%
4/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
General disorders
Catheter site bruise
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
2.0%
1/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
3.6%
2/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
General disorders
Medical device site dermatitis
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
3.5%
2/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
General disorders
Catheter site irritation
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
General disorders
Medical device site irritation
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
General disorders
Medical device site pruritus
|
3.6%
2/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
3.6%
2/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
General disorders
Medical device site reaction
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
2.0%
1/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
3.6%
2/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
General disorders
Application site vesicles
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
General disorders
Asthenia
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
General disorders
Catheter site erythema
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
General disorders
Catheter site pruritus
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
General disorders
Catheter site swelling
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
General disorders
Chest discomfort
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
2.0%
1/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
General disorders
Chest pain
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
General disorders
Fatigue
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
General disorders
Medical device site erythema
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
General disorders
Pyrexia
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Nervous system disorders
Headache
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
4.0%
2/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
5.5%
3/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
7.0%
4/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
2.0%
1/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
3.6%
2/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
7.0%
4/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
3.6%
2/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
2.0%
1/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
7.3%
4/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
3.5%
2/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
5.5%
3/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
4.0%
2/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
9.1%
5/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
2.0%
1/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
7.3%
4/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
7.3%
4/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
3.5%
2/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
2.0%
1/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Cardiac disorders
Sinus bradycardia
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
3.5%
2/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
3.5%
2/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
2.0%
1/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
2.0%
1/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Investigations
Electrocardiogram PR prolongation
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Investigations
Weight decreased
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
2.0%
1/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
2.0%
1/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
2.0%
1/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Endocrine disorders
Ear discomfort
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Ear and labyrinth disorders
Hyperacusis
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Eye disorders
Dry eye
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Eye disorders
Eye pain
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Eye disorders
Photophobia
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/50 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
1.8%
1/55 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
0.00%
0/57 • Both AEs and SAEs were recorded from the time the patient signs the ICF (28 days before Day 1) until the follow-up visit (Day 29±2 days) or at early termination. The longest period of time over which adverse event data were collected is 59 days.
Safety outcome measures included incidence and severity of adverse events, incidence of laboratory abnormalities, 12-lead ECG parameters, and vital sign measurements. Per protocol, approximately 68 healthy subjects will be randomized into 2 groups (Group 1 and 2). Only subjects in Group 1 received CBP-307, while all subjects in Group2 received CBP-307 matched placebo. When evaluating the safety of CBP-307 in this study, using combined Group 2 (Group 2A and 2B) as control group is reasonable.
|
Additional Information
Dr. Chin Lee, MD Chief Medial Officer
Connect Biopharma
Phone: +1 650 676 9617
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60