Trial Outcomes & Findings for An Extension Study of V203-AD Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UB-311 (NCT NCT03531710)

NCT ID: NCT03531710

Last Updated: 2021-01-26

Results Overview

Summary of Treatment Emergent Adverse Events (TEAEs), based on reported adverse events and other safety information including local tolerability at injection site, MRI, vital signs, physical examination, 12-lead ECG and laboratory tests.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 34 participants
• Primary outcome timeframe: Overall Study Duration/Early Termination, over an average study duration of 326 days
• Results posted on: 2021-01-26

Participant Flow

Participant milestones

Measure	M7E1 Treatment Group Arm 1 from V203-AD (M7) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M7E3 Treatment Group Arm 1 from V203-AD (M7) received 3 doses of UB-311 in V203-AD-EXT (E3)	M5E1 Treatment Group Arm 2 from V203-AD (M5) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M5E3 Treatment Group Arm 2 from V203-AD (M5) received 3 doses of UB-311 in V203-AD-EXT (E3)	M0E1 Treatment Group Arm 3 from V203-AD (M0) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M0E3 Treatment Group Arm 3 from V203-AD (M0) received 3 doses of UB-311 in V203-AD-EXT (E3)
Overall Study STARTED	10	2	7	5	8	2
Overall Study COMPLETED	8	2	7	5	8	2
Overall Study NOT COMPLETED	2	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Extension Study of V203-AD Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UB-311

Baseline characteristics by cohort

Measure	M7E1 n=10 Participants Treatment Group Arm 1 from V203-AD (M7) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M7E3 n=2 Participants Treatment Group Arm 1 from V203-AD (M7) received 3 doses of UB-311 in V203-AD-EXT (E3)	M5E1 n=7 Participants Treatment Group Arm 2 from V203-AD (M5) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M5E3 n=5 Participants Treatment Group Arm 2 from V203-AD (M5) received 3 doses of UB-311 in V203-AD-EXT (E3)	M0E1 n=8 Participants Treatment Group Arm 3 from V203-AD (M0) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M0E3 n=2 Participants Treatment Group Arm 3 from V203-AD (M0) received 3 doses of UB-311 in V203-AD-EXT (E3)	Total n=34 Participants Total of all reporting groups
Age, Continuous	73.2 years STANDARD_DEVIATION 5.81 • n=5 Participants	83.0 years STANDARD_DEVIATION 7.07 • n=7 Participants	75.4 years STANDARD_DEVIATION 7.74 • n=5 Participants	71.6 years STANDARD_DEVIATION 6.8 • n=4 Participants	74.9 years STANDARD_DEVIATION 8.31 • n=21 Participants	70.5 years STANDARD_DEVIATION 4.95 • n=10 Participants	74.2 years STANDARD_DEVIATION 7.06 • n=115 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	2 Participants n=10 Participants	24 Participants n=115 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	10 Participants n=115 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	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	8 Participants n=21 Participants	2 Participants n=10 Participants	34 Participants n=115 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	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	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	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) White	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	0 Participants n=10 Participants	0 Participants n=115 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	0 Participants n=10 Participants	0 Participants n=115 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	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment Taiwan	10 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	5 Participants n=4 Participants	8 Participants n=21 Participants	2 Participants n=10 Participants	34 Participants n=115 Participants
Mini-Mental State Examination	17.2 units on a scale STANDARD_DEVIATION 7.05 • n=5 Participants	24 units on a scale STANDARD_DEVIATION 4.24 • n=7 Participants	18.71 units on a scale STANDARD_DEVIATION 5.74 • n=5 Participants	16.4 units on a scale STANDARD_DEVIATION 7.47 • n=4 Participants	18.13 units on a scale STANDARD_DEVIATION 5.92 • n=21 Participants	20.5 units on a scale STANDARD_DEVIATION 2.12 • n=10 Participants	18.21 units on a scale STANDARD_DEVIATION 6.13 • n=115 Participants

PRIMARY outcome

Timeframe: Overall Study Duration/Early Termination, over an average study duration of 326 days

Summary of Treatment Emergent Adverse Events (TEAEs), based on reported adverse events and other safety information including local tolerability at injection site, MRI, vital signs, physical examination, 12-lead ECG and laboratory tests.

Outcome measures

Measure	M7E1 n=10 Participants Treatment Group Arm 1 from V203-AD (M7) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M7E3 n=2 Participants Treatment Group Arm 1 from V203-AD (M7) received 3 doses of UB-311 in V203-AD-EXT (E3)	M5E1 n=7 Participants Treatment Group Arm 2 from V203-AD (M5) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M5E3 n=5 Participants Treatment Group Arm 2 from V203-AD (M5) received 3 doses of UB-311 in V203-AD-EXT (E3)	M0E1 n=8 Participants Treatment Group Arm 3 from V203-AD (M0) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M0E3 n=2 Participants Treatment Group Arm 3 from V203-AD (M0) received 3 doses of UB-311 in V203-AD-EXT (E3)
The Incidence of Adverse Event (AE)/Serious Adverse Event (SAE) [Safety and Tolerability]).	4 Participants	1 Participants	4 Participants	3 Participants	5 Participants	2 Participants

PRIMARY outcome

Timeframe: Overall Study Duration/Early Termination, over an average study duration of 326 days

For the immunogenicity assessment of the investigational product, UB-311, the level of anti-Aβ antibodies in the serum samples will be measured by a validated enzyme immunoassay manufactured by United Biomedical, Inc. (UBI). The level of anti-Aβ antibodies is assessed at every visit throughout the study period.

Outcome measures

Measure	M7E1 n=10 Participants Treatment Group Arm 1 from V203-AD (M7) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M7E3 n=2 Participants Treatment Group Arm 1 from V203-AD (M7) received 3 doses of UB-311 in V203-AD-EXT (E3)	M5E1 n=7 Participants Treatment Group Arm 2 from V203-AD (M5) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M5E3 n=5 Participants Treatment Group Arm 2 from V203-AD (M5) received 3 doses of UB-311 in V203-AD-EXT (E3)	M0E1 n=8 Participants Treatment Group Arm 3 from V203-AD (M0) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M0E3 n=2 Participants Treatment Group Arm 3 from V203-AD (M0) received 3 doses of UB-311 in V203-AD-EXT (E3)
Change From Baseline and Through to the End of the Study in Anti-Aβ Antibody Titers [The Immunogenicity of UB-311]	0.56 Geometric Mean Ratio in log10 Standard Deviation 0.72	0.11 Geometric Mean Ratio in log10 Standard Deviation 0.35	0.15 Geometric Mean Ratio in log10 Standard Deviation 0.35	0.49 Geometric Mean Ratio in log10 Standard Deviation 0.32	0.10 Geometric Mean Ratio in log10 Standard Deviation 0.24	0.80 Geometric Mean Ratio in log10 Standard Deviation 0.09

OTHER_PRE_SPECIFIED outcome

Timeframe: Overall Study Duration/Early Termination, over an average study duration of 326 days

Population: If more than one of 13 items of ADAS-Cog were missing/not available, ADASCog-13 total score was set to missing.

The ADAS-Cog 13 contains 13 items, with a total scoring range of 0 - 85 and higher scores indicating greater dysfunction. ADAS-Cog scores were evaluated at V1 and V8/ET. The observed values and change from baseline for ADAS-Cog scores by treatment groups in the extension study are presented

Outcome measures

Measure	M7E1 n=8 Participants Treatment Group Arm 1 from V203-AD (M7) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M7E3 n=2 Participants Treatment Group Arm 1 from V203-AD (M7) received 3 doses of UB-311 in V203-AD-EXT (E3)	M5E1 n=6 Participants Treatment Group Arm 2 from V203-AD (M5) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M5E3 n=5 Participants Treatment Group Arm 2 from V203-AD (M5) received 3 doses of UB-311 in V203-AD-EXT (E3)	M0E1 n=8 Participants Treatment Group Arm 3 from V203-AD (M0) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M0E3 n=2 Participants Treatment Group Arm 3 from V203-AD (M0) received 3 doses of UB-311 in V203-AD-EXT (E3)
Change From Baseline and Through to the End of the Study in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog);	2.86 score on a scale Standard Deviation 4.811	-0.50 score on a scale Standard Deviation 2.121	2.50 score on a scale Standard Deviation 4.324	5.67 score on a scale Standard Deviation 3.512	3.50 score on a scale Standard Deviation 3.564	1.00 score on a scale Standard Deviation 1.414

OTHER_PRE_SPECIFIED outcome

Timeframe: Overall Study Duration/Early Termination, over an average study duration of 326 days

The MMSE is a 30-point questionnaire. The total score range is 0 - 30 and lower scores indicating greater impairment. MMSE scores were evaluated at V1 and V8/ET. The observed values and change from baseline for MMSE scores by treatment groups in the extension study are presented

Outcome measures

Measure	M7E1 n=10 Participants Treatment Group Arm 1 from V203-AD (M7) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M7E3 n=2 Participants Treatment Group Arm 1 from V203-AD (M7) received 3 doses of UB-311 in V203-AD-EXT (E3)	M5E1 n=7 Participants Treatment Group Arm 2 from V203-AD (M5) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M5E3 n=5 Participants Treatment Group Arm 2 from V203-AD (M5) received 3 doses of UB-311 in V203-AD-EXT (E3)	M0E1 n=8 Participants Treatment Group Arm 3 from V203-AD (M0) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M0E3 n=2 Participants Treatment Group Arm 3 from V203-AD (M0) received 3 doses of UB-311 in V203-AD-EXT (E3)
Change From Baseline and Through to the End of the Study in Mini-Mental State Exam (MMSE)	-1.80 score on a scale Standard Deviation 3.225	-1.50 score on a scale Standard Deviation 2.121	-0.57 score on a scale Standard Deviation 1.618	-3.00 score on a scale Standard Deviation 4.183	-4.38 score on a scale Standard Deviation 4.868	-2.00 score on a scale Standard Deviation 2.828

OTHER_PRE_SPECIFIED outcome

Timeframe: Overall Study Duration/Early Termination, over an average study duration of 326 days

The CDR-SB includes 6 domains (0 - 3 points/domain), with a total scoring range of 0 - 18 and higher scores indicate greater impartment. CDR-SB scores were evaluated at V1 and V8/ET. The observed values and change from baseline for CDR-SB scores by treatment groups in the extension study are presented

Outcome measures

Measure	M7E1 n=10 Participants Treatment Group Arm 1 from V203-AD (M7) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M7E3 n=2 Participants Treatment Group Arm 1 from V203-AD (M7) received 3 doses of UB-311 in V203-AD-EXT (E3)	M5E1 n=7 Participants Treatment Group Arm 2 from V203-AD (M5) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M5E3 n=5 Participants Treatment Group Arm 2 from V203-AD (M5) received 3 doses of UB-311 in V203-AD-EXT (E3)	M0E1 n=8 Participants Treatment Group Arm 3 from V203-AD (M0) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M0E3 n=2 Participants Treatment Group Arm 3 from V203-AD (M0) received 3 doses of UB-311 in V203-AD-EXT (E3)
Change From Baseline and Through to the End of the Study in Clinical Dementia Rating - Sum of Boxes (CDR-SB)	1.50 score on a scale Standard Deviation 2.483	0.00 score on a scale Standard Deviation 0.000	0.64 score on a scale Standard Deviation 1.345	2.00 score on a scale Standard Deviation 3.082	3.69 score on a scale Standard Deviation 4.869	0.75 score on a scale Standard Deviation 1.061

Adverse Events

M7E1

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

M7E3

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

M5E1

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

M5E3

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

M0E1

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

M0E3

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	M7E1 n=10 participants at risk Treatment Group Arm 1 from V203-AD (M7) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M7E3 n=2 participants at risk Treatment Group Arm 1 from V203-AD (M7) received 3 doses of UB-311 in V203-AD-EXT (E3)	M5E1 n=7 participants at risk Treatment Group Arm 2 from V203-AD (M5) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M5E3 n=5 participants at risk Treatment Group Arm 2 from V203-AD (M5) received 3 doses of UB-311 in V203-AD-EXT (E3)	M0E1 n=8 participants at risk Treatment Group Arm 3 from V203-AD (M0) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M0E3 n=2 participants at risk Treatment Group Arm 3 from V203-AD (M0) received 3 doses of UB-311 in V203-AD-EXT (E3)
Infections and infestations Escherichia sepsis	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	12.5% 1/8 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Injury, poisoning and procedural complications Femoral neck fracture	10.0% 1/10 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/8 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	14.3% 1/7 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/8 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/8 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	50.0% 1/2 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Nervous system disorders Syncope	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	14.3% 1/7 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/8 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Nervous system disorders Hemorrhagic transformation stroke	10.0% 1/10 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/8 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.

Other adverse events

Measure	M7E1 n=10 participants at risk Treatment Group Arm 1 from V203-AD (M7) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M7E3 n=2 participants at risk Treatment Group Arm 1 from V203-AD (M7) received 3 doses of UB-311 in V203-AD-EXT (E3)	M5E1 n=7 participants at risk Treatment Group Arm 2 from V203-AD (M5) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M5E3 n=5 participants at risk Treatment Group Arm 2 from V203-AD (M5) received 3 doses of UB-311 in V203-AD-EXT (E3)	M0E1 n=8 participants at risk Treatment Group Arm 3 from V203-AD (M0) received 1 dose of UB-311 and 2 doses of placebo in V203-AD-EXT (E1)	M0E3 n=2 participants at risk Treatment Group Arm 3 from V203-AD (M0) received 3 doses of UB-311 in V203-AD-EXT (E3)
Blood and lymphatic system disorders Anaemia	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	12.5% 1/8 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Blood and lymphatic system disorders Purpura nonthrombocytopenic	10.0% 1/10 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/8 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Ear and labyrinth disorders Tinnitus	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	14.3% 1/7 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/8 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Eye disorders Dry eye	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	50.0% 1/2 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/8 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Gastrointestinal disorders Dental caries	10.0% 1/10 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/8 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Gastrointestinal disorders Oesophagitis	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	12.5% 1/8 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
General disorders Fatigue	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	14.3% 1/7 • Number of events 2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/8 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
General disorders Feeling abnormal	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	14.3% 1/7 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	12.5% 1/8 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
General disorders Vaccination site pain	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	20.0% 1/5 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	12.5% 1/8 • Number of events 2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	50.0% 1/2 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Infections and infestations Herpes zoster	10.0% 1/10 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/8 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Infections and infestations Influenza	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	12.5% 1/8 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Infections and infestations Pharyngitis	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	12.5% 1/8 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Infections and infestations Pneumonia	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	20.0% 1/5 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/8 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Infections and infestations Sinusitis	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	20.0% 1/5 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/8 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Infections and infestations Urinary tract infection bacterial	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	12.5% 1/8 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Injury, poisoning and procedural complications Accident at home	10.0% 1/10 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/8 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Injury, poisoning and procedural complications Back injury	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	50.0% 1/2 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/8 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Injury, poisoning and procedural complications Burns second degree	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	12.5% 1/8 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Investigations Inflammatory marker increased	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	20.0% 1/5 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/8 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	20.0% 1/5 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/8 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Benign neoplasm of skin	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	50.0% 1/2 • Number of events 3 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/8 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Renal and urinary disorders Urinary retention	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	12.5% 1/8 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	12.5% 1/8 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Respiratory, thoracic and mediastinal disorders Bronchitis chronic	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	20.0% 1/5 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/8 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/10 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/7 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/5 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	12.5% 1/8 • Number of events 1 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.	0.00% 0/2 • Adverse events collected from ICF to Early Termination Visit, mean study duration was 326.2 days.

Additional Information

Medical Director

United Neuroscience

Phone: +1 (972) 809-0481

Email: info@unitedneuroscience.com

Results disclosure agreements

• Principal investigator is a sponsor employee Site PIs must jointly publish results, unless permission is granted by Sponsor. If a joint publication is not done within 12 months after trial completion and database lock, then the site may publish its own results; provided that, a) Sponsor has 45 business days to review the proposed publication; b) the PI must delete any confidential information identified by Sponsor; and c) the PI must delay disclosure for 1 year if a patent application is filed by Sponsor.
• Publication restrictions are in place

Restriction type: OTHER