Trial Outcomes & Findings for A Phase 1/ Phase 2 Study of TTHX1114(NM141) (NCT NCT04520321)
NCT ID: NCT04520321
Last Updated: 2023-10-30
Results Overview
Suspected Adverse Reactions Reported Following Study Drug Adminsitration
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Day 90
Results posted on
2023-10-30
Participant Flow
Participant milestones
| Measure |
Vehicle (Placebo)
Placebo weekly x 4
Vehicle (placebo): Placebo
|
Low Dose
TTHX1114(NM141) low-dose weekly x 4
TTHX1114(NM141): engineered FGF-1 delivered intracamerally
|
Mid-dose
TTHX1114(NM141) mid-dose weekly x 4
TTHX1114(NM141): engineered FGF-1 delivered intracamerally
|
High-dose
TTHX1114(NM141) high-dose weekly x 4
TTHX1114(NM141): engineered FGF-1 delivered intracamerally
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
3
|
7
|
|
Overall Study
COMPLETED
|
5
|
7
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 1/ Phase 2 Study of TTHX1114(NM141)
Baseline characteristics by cohort
| Measure |
Vehicle (Placebo)
n=5 Participants
Placebo weekly x 4
Vehicle (placebo): Placebo
|
Low Dose
n=7 Participants
TTHX1114(NM141) low-dose weekly x 4
TTHX1114(NM141): engineered FGF-1 delivered intracamerally
|
Mid-dose
n=3 Participants
TTHX1114(NM141) mid-dose weekly x 4
TTHX1114(NM141): engineered FGF-1 delivered intracamerally
|
High-dose
n=7 Participants
TTHX1114(NM141) high-dose weekly x 4
TTHX1114(NM141): engineered FGF-1 delivered intracamerally
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
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)
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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
|
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
|
|
Age, Continuous
|
76.6 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
75.7 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
81.3 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
68.9 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
74.5 years
STANDARD_DEVIATION 10.5 • n=21 Participants
|
PRIMARY outcome
Timeframe: Day 90Population: Safety
Suspected Adverse Reactions Reported Following Study Drug Adminsitration
Outcome measures
| Measure |
Vehicle (Placebo)
n=5 Participants
Placebo weekly x 4
Vehicle (placebo): Placebo
|
Low Dose
n=7 Participants
TTHX1114(NM141) low-dose weekly x 4
TTHX1114(NM141): engineered FGF-1 delivered intracamerally
|
Mid-dose
n=3 Participants
TTHX1114(NM141) mid-dose weekly x 4
TTHX1114(NM141): engineered FGF-1 delivered intracamerally
|
High-dose
n=7 Participants
TTHX1114(NM141) high-dose weekly x 4
TTHX1114(NM141): engineered FGF-1 delivered intracamerally
|
|---|---|---|---|---|
|
DLTs/ Adverse Reactions
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Vehicle (Placebo)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Low Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Mid-dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
High-dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vehicle (Placebo)
n=5 participants at risk
Placebo weekly x 4
Vehicle (placebo): Placebo
|
Low Dose
n=7 participants at risk
TTHX1114(NM141) low-dose weekly x 4
TTHX1114(NM141): engineered FGF-1 delivered intracamerally
|
Mid-dose
n=3 participants at risk
TTHX1114(NM141) mid-dose weekly x 4
TTHX1114(NM141): engineered FGF-1 delivered intracamerally
|
High-dose
n=7 participants at risk
TTHX1114(NM141) high-dose weekly x 4
TTHX1114(NM141): engineered FGF-1 delivered intracamerally
|
|---|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
20.0%
1/5 • Number of events 1 • 90 days
|
0.00%
0/7 • 90 days
|
0.00%
0/3 • 90 days
|
0.00%
0/7 • 90 days
|
|
Eye disorders
Eye irritation
|
0.00%
0/5 • 90 days
|
0.00%
0/7 • 90 days
|
0.00%
0/3 • 90 days
|
14.3%
1/7 • 90 days
|
|
Eye disorders
Eye pain
|
0.00%
0/5 • 90 days
|
0.00%
0/7 • 90 days
|
33.3%
1/3 • 90 days
|
14.3%
1/7 • 90 days
|
|
Eye disorders
Foreign body sensation in eyes
|
20.0%
1/5 • Number of events 1 • 90 days
|
0.00%
0/7 • 90 days
|
0.00%
0/3 • 90 days
|
0.00%
0/7 • 90 days
|
|
Eye disorders
Iritis
|
0.00%
0/5 • 90 days
|
0.00%
0/7 • 90 days
|
0.00%
0/3 • 90 days
|
14.3%
1/7 • Number of events 1 • 90 days
|
|
Eye disorders
Photophobia
|
0.00%
0/5 • 90 days
|
14.3%
1/7 • 90 days
|
0.00%
0/3 • 90 days
|
14.3%
1/7 • 90 days
|
|
Eye disorders
Punctate keratitis
|
0.00%
0/5 • 90 days
|
0.00%
0/7 • 90 days
|
0.00%
0/3 • 90 days
|
14.3%
1/7 • 90 days
|
|
General disorders
Malaise
|
20.0%
1/5 • Number of events 1 • 90 days
|
0.00%
0/7 • 90 days
|
0.00%
0/3 • 90 days
|
0.00%
0/7 • 90 days
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/5 • 90 days
|
14.3%
1/7 • 90 days
|
0.00%
0/3 • 90 days
|
0.00%
0/7 • 90 days
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/5 • 90 days
|
14.3%
1/7 • 90 days
|
0.00%
0/3 • 90 days
|
0.00%
0/7 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
1/5 • Number of events 1 • 90 days
|
0.00%
0/7 • 90 days
|
0.00%
0/3 • 90 days
|
0.00%
0/7 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/5 • 90 days
|
0.00%
0/7 • 90 days
|
33.3%
1/3 • 90 days
|
0.00%
0/7 • 90 days
|
|
Vascular disorders
Lymphoedema
|
20.0%
1/5 • Number of events 1 • 90 days
|
0.00%
0/7 • 90 days
|
0.00%
0/3 • 90 days
|
0.00%
0/7 • 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place