Trial Outcomes & Findings for A Study to Evaluate the Safety and Tolerability of ONL1204 in Patients With Macula-off, Rhegmatogenous Retinal Detachment (NCT NCT03780972)
NCT ID: NCT03780972
Last Updated: 2024-09-24
Results Overview
AEs restricted to treatment-emergent AEs (TEAEs) only. Ocular and non-ocular AEs reported separately. See AE Reporting Table for descriptive ocular and non-ocular AE findings.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
24 weeks
Results posted on
2024-09-24
Participant Flow
Participant milestones
| Measure |
Cohort 1 Dose A
Intravitreal injection of 50 μl of ONL1204 liquid formulation to deliver dose A
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 2 Dose B
Intravitreal injection of 100 μl of ONL1204 liquid formulation to deliver dose B
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 3 Dose C
Intravitreal injection of 50 μl of ONL1204 liquid formulation to deliver dose C
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 4 Dose D
Intravitreal injection of 100 μl of ONL1204 liquid formulation to deliver dose D
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
2
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety and Tolerability of ONL1204 in Patients With Macula-off, Rhegmatogenous Retinal Detachment
Baseline characteristics by cohort
| Measure |
Cohort 1 Dose A
n=4 Participants
Intravitreal injection of 50 μl of ONL1204 liquid formulation to deliver dose 1
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 2 Dose B
n=4 Participants
Intravitreal injection of 100 μl of ONL1204 liquid formulation to deliver dose 2
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 3 Dose C
n=4 Participants
Intravitreal injection of 50 μl of ONL1204 liquid formulation to deliver dose 3
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 4 Dose D
n=2 Participants
Intravitreal injection of 100 μl of ONL1204 liquid formulation to deliver dose 4
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Age, Continuous
|
67.5 years
n=5 Participants
|
54.5 years
n=7 Participants
|
58 years
n=5 Participants
|
67.5 years
n=4 Participants
|
61 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 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
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 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
|
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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 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
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 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
Australia
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 24 weeksAEs restricted to treatment-emergent AEs (TEAEs) only. Ocular and non-ocular AEs reported separately. See AE Reporting Table for descriptive ocular and non-ocular AE findings.
Outcome measures
| Measure |
Cohort 1 Dose A
n=4 Participants
Intravitreal injection of 50 μl of ONL1204 liquid formulation to deliver dose A
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 2 Dose B
n=4 Participants
Intravitreal injection of 100 μl of ONL1204 liquid formulation to deliver dose B
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 3 Dose C
n=4 Participants
Intravitreal injection of 50 μl of ONL1204 liquid formulation to deliver dose C
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 4 Dose D
n=2 Participants
Intravitreal injection of 100 μl of ONL1204 liquid formulation to deliver dose D
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
|---|---|---|---|---|
|
Adverse Event (AE) Reporting
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 24 weeksBCVA was performed in the study eye using ETDRS methodology and letters read were converted to a logMAR value using the following equation: logMAR = -0.02 × ETDRS + 1.7.
Outcome measures
| Measure |
Cohort 1 Dose A
n=4 Participants
Intravitreal injection of 50 μl of ONL1204 liquid formulation to deliver dose A
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 2 Dose B
n=4 Participants
Intravitreal injection of 100 μl of ONL1204 liquid formulation to deliver dose B
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 3 Dose C
n=4 Participants
Intravitreal injection of 50 μl of ONL1204 liquid formulation to deliver dose C
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 4 Dose D
n=2 Participants
Intravitreal injection of 100 μl of ONL1204 liquid formulation to deliver dose D
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
|---|---|---|---|---|
|
BCVA (LogMAR) at Final Study Visit
|
0.52 logMAR
Interval 0.2 to 0.7
|
0.50 logMAR
Interval 0.2 to 0.8
|
0.77 logMAR
Interval 0.5 to 1.3
|
0.46 logMAR
Interval 0.2 to 0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksMeasurement of ONL1204 in plasma (ng/ml) after drug administration. For all subjects, the concentration was \<LLOQ.
Outcome measures
| Measure |
Cohort 1 Dose A
n=4 Participants
Intravitreal injection of 50 μl of ONL1204 liquid formulation to deliver dose A
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 2 Dose B
n=4 Participants
Intravitreal injection of 100 μl of ONL1204 liquid formulation to deliver dose B
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 3 Dose C
n=4 Participants
Intravitreal injection of 50 μl of ONL1204 liquid formulation to deliver dose C
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 4 Dose D
n=2 Participants
Intravitreal injection of 100 μl of ONL1204 liquid formulation to deliver dose D
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
|---|---|---|---|---|
|
Exploratory Outcome-ONL1204 Concentration
|
NA ng/ml
Standard Deviation NA
All samples collected were below the LLOQ.
|
NA ng/ml
Standard Deviation NA
All samples collected were below the LLOQ.
|
NA ng/ml
Standard Deviation NA
All samples collected were below the LLOQ.
|
NA ng/ml
Standard Deviation NA
All samples collected were below the LLOQ.
|
Adverse Events
Cohort 1 Dose A
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2 Dose B
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 3 Dose C
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 4 Dose D
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 Dose A
n=4 participants at risk
Intravitreal injection of 50 μl of ONL1204 liquid formulation to deliver dose A
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 2 Dose B
n=4 participants at risk
Intravitreal injection of 100 μl of ONL1204 liquid formulation to deliver dose B
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 3 Dose C
n=4 participants at risk
Intravitreal injection of 50 μl of ONL1204 liquid formulation to deliver dose C
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 4 Dose D
n=2 participants at risk
Intravitreal injection of 100 μl of ONL1204 liquid formulation to deliver dose D
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
|---|---|---|---|---|
|
Eye disorders
Retinal Re-Detachment
|
0.00%
0/4 • 6 months
|
50.0%
2/4 • Number of events 3 • 6 months
|
50.0%
2/4 • Number of events 3 • 6 months
|
0.00%
0/2 • 6 months
|
|
Eye disorders
Intraocular Inflammation
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
25.0%
1/4 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
Other adverse events
| Measure |
Cohort 1 Dose A
n=4 participants at risk
Intravitreal injection of 50 μl of ONL1204 liquid formulation to deliver dose A
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 2 Dose B
n=4 participants at risk
Intravitreal injection of 100 μl of ONL1204 liquid formulation to deliver dose B
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 3 Dose C
n=4 participants at risk
Intravitreal injection of 50 μl of ONL1204 liquid formulation to deliver dose C
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
Cohort 4 Dose D
n=2 participants at risk
Intravitreal injection of 100 μl of ONL1204 liquid formulation to deliver dose D
ONL1204: Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
Intravitreal Injection: Injection of study drug into the eye
Collection of ocular fluids: vitreous and aqueous fluid collection by a tap and during vitrectomy
|
|---|---|---|---|---|
|
Eye disorders
Cataract or Worsening of Cataract
|
0.00%
0/4 • 6 months
|
25.0%
1/4 • 6 months
|
50.0%
2/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Eye disorders
Ocular pain post intravitreal injection/injury
|
25.0%
1/4 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Eye disorders
Elevated Intraocular Pressure
|
25.0%
1/4 • 6 months
|
25.0%
1/4 • 6 months
|
0.00%
0/4 • 6 months
|
50.0%
1/2 • 6 months
|
|
Eye disorders
Redness/Ocular Hyperaemia
|
25.0%
1/4 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Eye disorders
Nerve Fiber Lesions/OCT Abnormalities
|
25.0%
1/4 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Gastrointestinal disorders
Food Poisoning/Gastrointestinal Disorders
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
25.0%
1/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
General disorders
Covid-19 Positive
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
50.0%
1/2 • 6 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
50.0%
1/2 • 6 months
|
|
Skin and subcutaneous tissue disorders
Redness of skin
|
0.00%
0/4 • 6 months
|
25.0%
1/4 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Eye disorders
Ocular Pain
|
0.00%
0/4 • 6 months
|
25.0%
1/4 • 6 months
|
25.0%
1/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Eye disorders
Anterior Uveitis
|
0.00%
0/4 • 6 months
|
50.0%
2/4 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Eye disorders
Intraretinal Fluid
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
25.0%
1/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Eye disorders
Ocular Inflammation
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
25.0%
1/4 • 6 months
|
50.0%
1/2 • 6 months
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • 6 months
|
25.0%
1/4 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Pain Frontal Bone Above Left Eye
|
25.0%
1/4 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Hepatobiliary disorders
Gall Bladder Stones
|
25.0%
1/4 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Gastrointestinal disorders
Abdomen Pain
|
0.00%
0/4 • 6 months
|
25.0%
1/4 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Bilateral Shoulder Pain
|
0.00%
0/4 • 6 months
|
25.0%
1/4 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Injury, poisoning and procedural complications
Cryo Scars
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
25.0%
1/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Eye disorders
Retinal Hole
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
25.0%
1/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Eye disorders
Punctate Epithelial Erosions
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
25.0%
1/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Eye disorders
Floaters
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
25.0%
1/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Eye disorders
Intraocular Lens Opacified
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
25.0%
1/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Eye disorders
Lattice with Atrophic Hole
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
25.0%
1/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Eye disorders
Retinal Degeneration
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
25.0%
1/4 • 6 months
|
0.00%
0/2 • 6 months
|
|
Eye disorders
Gel Like Substance in Vitreous Cavity
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
0.00%
0/4 • 6 months
|
50.0%
1/2 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place