Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Infusion of XTMAB-16 in Healthy Adult Participants (NCT NCT04971395)
NCT ID: NCT04971395
Last Updated: 2025-01-14
Results Overview
Treatment-emergent adverse event, which is an undesirable event that occurs during or shortly after treatment begins.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Up to day 71
Results posted on
2025-01-14
Participant Flow
A total of 24 normal healthy adult participants were planned to be enrolled and assigned into 2 treatment cohorts with 12 participants (9 on XTMAB-16 and 3 on placebo). Participants received a single IV infusion of 2 or 4 mg/kg of study drug (XTMAB-16 or placebo) on Day 1.
Participant milestones
| Measure |
Pooled Placebo
Participants received a single IV Infusion of Placebo
|
Single IV Infusion of 2 mg/kg of XTMAB-16
Participants received a single dose of 2 mg/kg of XTMAB-16
|
Single IV Infusion of 4 mg/kg of XTMAB-16
Participants received a single dose of 4 mg/kg of XTMAB-16
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
10
|
9
|
|
Overall Study
COMPLETED
|
6
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Pooled Placebo
Participants received a single IV Infusion of Placebo
|
Single IV Infusion of 2 mg/kg of XTMAB-16
Participants received a single dose of 2 mg/kg of XTMAB-16
|
Single IV Infusion of 4 mg/kg of XTMAB-16
Participants received a single dose of 4 mg/kg of XTMAB-16
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Infusion of XTMAB-16 in Healthy Adult Participants
Baseline characteristics by cohort
| Measure |
Single IV Infusion of 2 mg/kg of XTMAB-16
n=10 Participants
Participants received a single dose of 2 mg/kg XTMAB-16
|
Single IV Infusion of 4 mg/kg of XTMAB-16
n=9 Participants
Participants received a single dose of 4 mg/kg XTMAB-16
|
Pooled Placebo
n=6 Participants
Participants received a single IV Infusion of Placebo
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to day 71Treatment-emergent adverse event, which is an undesirable event that occurs during or shortly after treatment begins.
Outcome measures
| Measure |
4 mg/kg XTMAB-16
n=9 Participants
Single IV Infusion of 4 mg/kg XTMAB-16
|
Pooled Placebo
n=6 Participants
Single IV Infusion of Placebo
|
2 mg/kg XTMAB-16
n=10 Participants
Single IV Infusion of 2 mg/kg XTMAB-16
|
|---|---|---|---|
|
Participant With Treatment Emergent Adverse Events (TEAEs)
|
3 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71Participants by cohort who test positive for XTMAB-16 ADA
Outcome measures
| Measure |
4 mg/kg XTMAB-16
n=9 Participants
Single IV Infusion of 4 mg/kg XTMAB-16
|
Pooled Placebo
n=6 Participants
Single IV Infusion of Placebo
|
2 mg/kg XTMAB-16
n=10 Participants
Single IV Infusion of 2 mg/kg XTMAB-16
|
|---|---|---|---|
|
Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)
Day 1 ADA Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)
Day 8 ADA Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)
Day 15 ADA Screening
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)
Day 15 ADA Confirmatory
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)
Day 29 ADA Screening
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)
Day 29 ADA Confirmatory
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)
Day 43 ADA Screening
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)
Day 43 ADA Confirmatory
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)
Day 57 ADA Screening
|
1 Participants
|
0 Participants
|
6 Participants
|
|
Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)
Day 57 ADA Confirmatory
|
1 Participants
|
0 Participants
|
5 Participants
|
|
Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)
Day 71 ADA Screening
|
3 Participants
|
0 Participants
|
6 Participants
|
|
Participants by Cohort Who Test Positive for XTMAB-16 Anti-drug Antibody (ADA)
Day 71 ADA Confirmatory
|
2 Participants
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: ADA and nAB: Days 1, 8, 15, 29, 43, 57, 71Participants by cohort who test positive for XTMAB-16 nAb
Outcome measures
| Measure |
4 mg/kg XTMAB-16
n=9 Participants
Single IV Infusion of 4 mg/kg XTMAB-16
|
Pooled Placebo
n=6 Participants
Single IV Infusion of Placebo
|
2 mg/kg XTMAB-16
n=10 Participants
Single IV Infusion of 2 mg/kg XTMAB-16
|
|---|---|---|---|
|
Participants by Cohort Who Test Positive for XTMAB-16 Neutralizing Antibody (nAb)
Day 29
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Participants by Cohort Who Test Positive for XTMAB-16 Neutralizing Antibody (nAb)
Day 43
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Participants by Cohort Who Test Positive for XTMAB-16 Neutralizing Antibody (nAb)
Day 57
|
1 Participants
|
0 Participants
|
5 Participants
|
|
Participants by Cohort Who Test Positive for XTMAB-16 Neutralizing Antibody (nAb)
Day 71
|
2 Participants
|
0 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to day 71XTMAB-16 (Cmax)
Outcome measures
| Measure |
4 mg/kg XTMAB-16
n=9 Participants
Single IV Infusion of 4 mg/kg XTMAB-16
|
Pooled Placebo
Single IV Infusion of Placebo
|
2 mg/kg XTMAB-16
n=10 Participants
Single IV Infusion of 2 mg/kg XTMAB-16
|
|---|---|---|---|
|
XTMAB-16 Maximum Observed Concentration (Cmax)
|
131 Cmax (μg/mL)
Standard Deviation 23.42
|
—
|
64.17 Cmax (μg/mL)
Standard Deviation 9.94
|
SECONDARY outcome
Timeframe: Day 1XTMAB-16 serum (CT) Day 1
Outcome measures
| Measure |
4 mg/kg XTMAB-16
n=9 Participants
Single IV Infusion of 4 mg/kg XTMAB-16
|
Pooled Placebo
Single IV Infusion of Placebo
|
2 mg/kg XTMAB-16
n=10 Participants
Single IV Infusion of 2 mg/kg XTMAB-16
|
|---|---|---|---|
|
XTMAB-16 Serum Observed Plasma Concentration at the End of Infusion (CT) Day 1
|
128.9 CT (μg/mL)
Standard Deviation 22.39
|
—
|
62.18 CT (μg/mL)
Standard Deviation 6.757
|
SECONDARY outcome
Timeframe: PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71Time to maximum observed concentration (tmax) XTMAB-16
Outcome measures
| Measure |
4 mg/kg XTMAB-16
n=9 Participants
Single IV Infusion of 4 mg/kg XTMAB-16
|
Pooled Placebo
Single IV Infusion of Placebo
|
2 mg/kg XTMAB-16
n=10 Participants
Single IV Infusion of 2 mg/kg XTMAB-16
|
|---|---|---|---|
|
Time to Maximum Observed Concentration (Tmax) XTMAB-16
|
3.0 tmax (h)
Interval 2.12 to 8.02
|
—
|
2.16 tmax (h)
Interval 2.1 to 8.65
|
SECONDARY outcome
Timeframe: PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71Area under the XTMAB-16 concentration-time curve from time zero (predose) AUC0-∞
Outcome measures
| Measure |
4 mg/kg XTMAB-16
n=9 Participants
Single IV Infusion of 4 mg/kg XTMAB-16
|
Pooled Placebo
Single IV Infusion of Placebo
|
2 mg/kg XTMAB-16
n=8 Participants
Single IV Infusion of 2 mg/kg XTMAB-16
|
|---|---|---|---|
|
Area Under the XTMAB-16 Concentration-time Curve From Time Zero (Predose) Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-∞)
|
1249 AUC0-inf (day*μg/mL)
Standard Deviation 245.0
|
—
|
601.5 AUC0-inf (day*μg/mL)
Standard Deviation 231.8
|
SECONDARY outcome
Timeframe: PK: Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71Area under the XTMAB-16 concentration-time-curve from time zero to (predose) AUC0-t
Outcome measures
| Measure |
4 mg/kg XTMAB-16
n=9 Participants
Single IV Infusion of 4 mg/kg XTMAB-16
|
Pooled Placebo
Single IV Infusion of Placebo
|
2 mg/kg XTMAB-16
n=9 Participants
Single IV Infusion of 2 mg/kg XTMAB-16
|
|---|---|---|---|
|
Area Under the XTMAB-16 Concentration-time-curve From Time Zero to (Predose) Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t)
|
1224 AUC0-last (day*μg/mL)
Standard Deviation 235.9
|
—
|
525.2 AUC0-last (day*μg/mL)
Standard Deviation 238.0
|
SECONDARY outcome
Timeframe: Up to day 71Systemic clearance after IV dosing (CL)
Outcome measures
| Measure |
4 mg/kg XTMAB-16
n=9 Participants
Single IV Infusion of 4 mg/kg XTMAB-16
|
Pooled Placebo
Single IV Infusion of Placebo
|
2 mg/kg XTMAB-16
n=8 Participants
Single IV Infusion of 2 mg/kg XTMAB-16
|
|---|---|---|---|
|
Systemic Clearance After IV Dosing (CL)
|
0.2449 CL (L/day)
Standard Deviation 0.06064
|
—
|
0.2498 CL (L/day)
Standard Deviation 0.04883
|
SECONDARY outcome
Timeframe: Up to day 71Outcome measures
| Measure |
4 mg/kg XTMAB-16
n=9 Participants
Single IV Infusion of 4 mg/kg XTMAB-16
|
Pooled Placebo
Single IV Infusion of Placebo
|
2 mg/kg XTMAB-16
n=8 Participants
Single IV Infusion of 2 mg/kg XTMAB-16
|
|---|---|---|---|
|
Apparent Terminal Half-life (t1/2)
|
10.23 t1/2 (day)
Standard Deviation 3.617
|
—
|
8.644 t1/2 (day)
Standard Deviation 4.726
|
SECONDARY outcome
Timeframe: Up to day 71Outcome measures
| Measure |
4 mg/kg XTMAB-16
n=9 Participants
Single IV Infusion of 4 mg/kg XTMAB-16
|
Pooled Placebo
Single IV Infusion of Placebo
|
2 mg/kg XTMAB-16
n=8 Participants
Single IV Infusion of 2 mg/kg XTMAB-16
|
|---|---|---|---|
|
Volume of Distribution Following IV Dosing (Vz) Day 1 up to Day 71
|
3.435 Vz (L)
Standard Deviation 0.9878
|
—
|
2.864 Vz (L)
Standard Deviation 0.8861
|
SECONDARY outcome
Timeframe: Up to day 71Mean residence time (MRT)
Outcome measures
| Measure |
4 mg/kg XTMAB-16
n=9 Participants
Single IV Infusion of 4 mg/kg XTMAB-16
|
Pooled Placebo
Single IV Infusion of Placebo
|
2 mg/kg XTMAB-16
n=8 Participants
Single IV Infusion of 2 mg/kg XTMAB-16
|
|---|---|---|---|
|
Mean Residence Time (MRT)
|
13.32 MRT (day)
Standard Deviation 3.794
|
—
|
12.51 MRT (day)
Standard Deviation 6.214
|
Adverse Events
2 mg/kg XTMAB-16
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
4 mg/kg XTMAB-16
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Pooled Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
2 mg/kg XTMAB-16
n=10 participants at risk
Single IV Infusion of 2 mg/kg XTMAB-16
|
4 mg/kg XTMAB-16
n=9 participants at risk
Single IV Infusion of 4 mg/kg XTMAB-16
|
Pooled Placebo
n=6 participants at risk
Single IV Infusion of Placebo
|
|---|---|---|---|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/10 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
11.1%
1/9 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/6 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
Other adverse events
| Measure |
2 mg/kg XTMAB-16
n=10 participants at risk
Single IV Infusion of 2 mg/kg XTMAB-16
|
4 mg/kg XTMAB-16
n=9 participants at risk
Single IV Infusion of 4 mg/kg XTMAB-16
|
Pooled Placebo
n=6 participants at risk
Single IV Infusion of Placebo
|
|---|---|---|---|
|
General disorders
Fatigue
|
10.0%
1/10 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
11.1%
1/9 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/6 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
22.2%
2/9 • Number of events 2 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/6 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
10.0%
1/10 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
11.1%
1/9 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/6 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
|
Nervous system disorders
Lethargy
|
10.0%
1/10 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/9 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/6 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/9 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/6 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
|
Gastrointestinal disorders
Emesis
|
10.0%
1/10 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/9 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/6 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
|
General disorders
Catheter Site Pain
|
10.0%
1/10 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/9 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/6 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/10 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
11.1%
1/9 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/6 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
11.1%
1/9 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/6 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/10 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
22.2%
2/9 • Number of events 2 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/6 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/10 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
11.1%
1/9 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
16.7%
1/6 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/10 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
11.1%
1/9 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/6 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
|
Eye disorders
Eye Pain due to Covid Testing
|
0.00%
0/10 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/9 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
16.7%
1/6 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
0.00%
0/10 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
11.1%
1/9 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/6 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/10 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
11.1%
1/9 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/6 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
|
Nervous system disorders
Lightheadedness
|
0.00%
0/10 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
11.1%
1/9 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/6 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/10 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
22.2%
2/9 • Number of events 2 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/6 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/10 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
11.1%
1/9 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/6 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
|
Gastrointestinal disorders
Loose Stool
|
0.00%
0/10 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
11.1%
1/9 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/6 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
|
General disorders
Foggy Feeling
|
0.00%
0/10 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
11.1%
1/9 • Number of events 1 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
0.00%
0/6 • The Investigator or designee recorded all reportable events with start dates occurring from informed consent until 7 (for nonserious AEs) or 30 days (for SAEs) after the last day of study participation. Study participation was up to 71 days.
|
Additional Information
Tom Matthews, Director of Clinical Research
Xentria, Inc.
Phone: 224.443.4615
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place