Trial Outcomes & Findings for Safety and Blood Levels After a Single Injection of UPB-101 in Healthy Japanese and Non-Japanese Non-East Asian Adults (NCT NCT05653479)
NCT ID: NCT05653479
Last Updated: 2024-09-03
Results Overview
Non-compartmental analysis was used for estimation of PK parameters.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Baseline through Day 85
Results posted on
2024-09-03
Participant Flow
Treatment groups 1, 2, and 3 consisted of Japanese adults who were administered a single SC dose of a low, medium, or high dose of UPB-101, respectively. Treatment group 4 consisted of NJNEA participants who received a single SC dose of a high dose UPB-101.
Participant milestones
| Measure |
Low Dose, Japanese
Single subcutaneous injection of a low dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
Medium Dose, Japanese
Single subcutaneous injection of a medium dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
High Dose, Japanese
Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
High Dose, NJNEA
Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Non-Japanese Non-East Asian participants
UPB-101: UPB-101 Subcutaneous injection
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
8
|
8
|
8
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Blood Levels After a Single Injection of UPB-101 in Healthy Japanese and Non-Japanese Non-East Asian Adults
Baseline characteristics by cohort
| Measure |
Low Dose, Japanese
n=8 Participants
Single subcutaneous injection of a low dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
Medium Dose, Japanese
n=8 Participants
Single subcutaneous injection of a medium dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
High Dose, Japanese
n=8 Participants
Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
High Dose, NJNEA
n=8 Participants
Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Non-Japanese Non-East Asian participants
UPB-101: UPB-101 Subcutaneous injection
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
31.0 years
STANDARD_DEVIATION 5.66 • n=5 Participants
|
28.6 years
STANDARD_DEVIATION 5.42 • n=7 Participants
|
31.9 years
STANDARD_DEVIATION 5.46 • n=5 Participants
|
25.1 years
STANDARD_DEVIATION 3.68 • n=4 Participants
|
29.2 years
STANDARD_DEVIATION 5.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
25 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (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
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
8 participants
n=4 Participants
|
32 participants
n=21 Participants
|
|
Body Mass Index
|
20.7 kg/m^2
STANDARD_DEVIATION 0.81 • n=5 Participants
|
21.2 kg/m^2
STANDARD_DEVIATION 1.77 • n=7 Participants
|
20.1 kg/m^2
STANDARD_DEVIATION 1.77 • n=5 Participants
|
21.7 kg/m^2
STANDARD_DEVIATION 1.73 • n=4 Participants
|
20.9 kg/m^2
STANDARD_DEVIATION 1.5 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 85Non-compartmental analysis was used for estimation of PK parameters.
Outcome measures
| Measure |
Low Dose, Japanese
n=8 Participants
Single subcutaneous injection of a low dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
Medium Dose, Japanese
n=8 Participants
Single subcutaneous injection of a medium dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
High Dose, Japanese
n=8 Participants
Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
High Dose, NJNEA
n=8 Participants
Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Non-Japanese Non-East Asian participants
UPB-101: UPB-101 Subcutaneous injection
|
|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of UPB-101
|
11.6 ug/mL
Standard Deviation 2.21
|
24.4 ug/mL
Standard Deviation 4.77
|
35.1 ug/mL
Standard Deviation 12.2
|
34.9 ug/mL
Standard Deviation 6.31
|
PRIMARY outcome
Timeframe: Baseline through Day 85Non-compartmental analysis was used for estimation of PK parameters.
Outcome measures
| Measure |
Low Dose, Japanese
n=8 Participants
Single subcutaneous injection of a low dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
Medium Dose, Japanese
n=8 Participants
Single subcutaneous injection of a medium dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
High Dose, Japanese
n=8 Participants
Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
High Dose, NJNEA
n=8 Participants
Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Non-Japanese Non-East Asian participants
UPB-101: UPB-101 Subcutaneous injection
|
|---|---|---|---|---|
|
Time to Maximum Observed Concentration (Tmax) of UPB-101
|
8.50 days
Interval 4.0 to 12.0
|
8.00 days
Interval 5.0 to 12.0
|
8.00 days
Interval 5.0 to 14.0
|
7.00 days
Interval 5.0 to 10.0
|
PRIMARY outcome
Timeframe: Baseline through Day 85Population: AUClast
Non-compartmental analysis was used for estimation of PK parameters. AUC = Area under the concentration-time curve
Outcome measures
| Measure |
Low Dose, Japanese
n=8 Participants
Single subcutaneous injection of a low dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
Medium Dose, Japanese
n=8 Participants
Single subcutaneous injection of a medium dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
High Dose, Japanese
n=8 Participants
Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
High Dose, NJNEA
n=8 Participants
Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Non-Japanese Non-East Asian participants
UPB-101: UPB-101 Subcutaneous injection
|
|---|---|---|---|---|
|
AUC From Time Zero up to the Last Quantifiable Concentration of UPB-101 (AUClast)
|
407 day*ug/mL
Standard Deviation 88.5
|
755 day*ug/mL
Standard Deviation 84.2
|
1300 day*ug/mL
Standard Deviation 475
|
1200 day*ug/mL
Standard Deviation 235
|
SECONDARY outcome
Timeframe: Baseline through Day 85Safety endpoints included AEs, SAEs, physical examinations, clinical laboratory assessments, vital signs, ECGs including telemetry, withdrawal of participants, and early terminations.
Outcome measures
| Measure |
Low Dose, Japanese
n=8 Participants
Single subcutaneous injection of a low dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
Medium Dose, Japanese
n=8 Participants
Single subcutaneous injection of a medium dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
High Dose, Japanese
n=8 Participants
Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
High Dose, NJNEA
n=8 Participants
Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Non-Japanese Non-East Asian participants
UPB-101: UPB-101 Subcutaneous injection
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events
|
4 Participants
|
4 Participants
|
7 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline through Day 85The immunogenicity endpoints included UPB-101 Anti-Drug Antibodies (ADAs). Outcome data is the number of participants with Low titer ADA positive results (range 60-240) observed at Day 85.
Outcome measures
| Measure |
Low Dose, Japanese
n=8 Participants
Single subcutaneous injection of a low dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
Medium Dose, Japanese
n=8 Participants
Single subcutaneous injection of a medium dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
High Dose, Japanese
n=8 Participants
Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
High Dose, NJNEA
n=8 Participants
Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Non-Japanese Non-East Asian participants
UPB-101: UPB-101 Subcutaneous injection
|
|---|---|---|---|---|
|
Immunogenicity Assessment of UPB-101 When Administered to Japanese and NJNEA Adults
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
Adverse Events
Low Dose, Japanese
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Medium Dose, Japanese
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
High Dose, Japanese
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
High Dose, NJNEA
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose, Japanese
n=8 participants at risk
Single subcutaneous injection of a low dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
Medium Dose, Japanese
n=8 participants at risk
Single subcutaneous injection of a medium dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
High Dose, Japanese
n=8 participants at risk
Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Japanese participants
UPB-101: UPB-101 Subcutaneous injection
|
High Dose, NJNEA
n=8 participants at risk
Single subcutaneous injection of a high dose of UPB-101 (formerly ASP7266) in 8 Non-Japanese Non-East Asian participants
UPB-101: UPB-101 Subcutaneous injection
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Cardiac disorders
Palpitations
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Ear and labyrinth disorders
Inner ear inflammation
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Eye disorders
Vision blurred
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Infections and infestations
COVID-19
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Infections and infestations
Conjunctivitis
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Infections and infestations
Upper respiratory tract infection
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
50.0%
4/8 • Number of events 5 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
50.0%
4/8 • Number of events 4 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Infections and infestations
Viral infection
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Injury, poisoning and procedural complications
Medical device site reaction
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
12.5%
1/8 • Number of events 2 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
25.0%
2/8 • Number of events 2 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Nervous system disorders
Presyncope
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Nervous system disorders
Syncope
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Reproductive system and breast disorders
Menstruation irregular
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Reproductive system and breast disorders
Premenstrual pain
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
25.0%
2/8 • Number of events 2 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Skin and subcutaneous tissue disorders
Blister
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
12.5%
1/8 • Number of events 1 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
0.00%
0/8 • Baseline through Day 85
Adverse event (AE) data are listed and summarized using descriptive statistics: the number (and %) of participants who had any AEs and the number of AE episodes are summarized by each treatment group
|
Additional Information
Sumathi Sivapalasingam, Vice President of Clinical Development
Upstream Bio
Phone: 1 917-499-0789
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place