Trial Outcomes & Findings for A Study of BI 765128 in Patients With an Eye Condition Called Diabetic Macular Ischemia Who Have Received Laser Treatment (NCT NCT04919499)
NCT ID: NCT04919499
Last Updated: 2024-11-21
Results Overview
Dose limiting events were defined in the clinical trial protocol as any of the following occurrences in the eye being studied during the evaluation period: * development of sterile endophthalmitis and/or sterile inflammation of the vitreous of 3+ (out of 0, 0.5+,1+,2+,3+ and 4+, where 0 is clear vitreous and 4+ is an obscured vitreous) according to the NEI (National Eye Institute) Grading of vitreous haze, and anterior chamber cells of 3+ (out of 0, 0.5+,1+,2+,3+ and 4+, where 0 is no inflammation and 4+ is severe inflammation) according to the Standardization of Uveitis Nomenclature (SUN) working group (WG) grading scheme for 5 or more days; * visual loss of more than 15 letters at any given time-point; persistent intra-ocular pressure over 30 mmHg for 3 days; * and signs of vascular occlusion in a first (the main branch) or second degree (the vessel after the first bifurcation of the main branch) retinal vessel.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
46 participants
Primary outcome timeframe
From initial drug administration (day 1) until day 8.
Results posted on
2024-11-21
Participant Flow
This was a trial consisting of a non-randomised, uncontrolled, open label single rising dose part (Part A) and a randomised, sham controlled, double-masked multiple doses part (Part B).
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. One eye was selected, according to inclusion /exclusion criteria, as the study eye to be treated.
Participant milestones
| Measure |
Single Rising Dose Part: Low-dose BI 765128
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of low-dose BI 765128.
|
Single Rising Dose Part: Medium-dose BI 765128
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of medium-dose BI 765128.
|
Single Rising Dose Part: High-dose BI 765128
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of high-dose BI 765128.
|
Multiple Dose Part: Sham
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received 3 single intravitreal sham injection at week 1, 4 and 8.
|
Multiple Dose Part: High-dose BI 765128
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received 3 single intravitreal injection of high-dose BI 765128 at week 1, 4 and 8.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
11
|
23
|
|
Overall Study
Treated
|
3
|
3
|
6
|
10
|
23
|
|
Overall Study
COMPLETED
|
3
|
3
|
6
|
10
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Single Rising Dose Part: Low-dose BI 765128
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of low-dose BI 765128.
|
Single Rising Dose Part: Medium-dose BI 765128
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of medium-dose BI 765128.
|
Single Rising Dose Part: High-dose BI 765128
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of high-dose BI 765128.
|
Multiple Dose Part: Sham
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received 3 single intravitreal sham injection at week 1, 4 and 8.
|
Multiple Dose Part: High-dose BI 765128
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received 3 single intravitreal injection of high-dose BI 765128 at week 1, 4 and 8.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
2
|
|
Overall Study
Not treated
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of BI 765128 in Patients With an Eye Condition Called Diabetic Macular Ischemia Who Have Received Laser Treatment
Baseline characteristics by cohort
| Measure |
Single Rising Dose Part: Low-dose BI 765128
n=3 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of low-dose BI 765128.
|
Single Rising Dose Part: Medium-dose BI 765128
n=3 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of medium-dose BI 765128.
|
Single Rising Dose Part: High-dose BI 765128
n=6 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of high-dose BI 765128.
|
Multiple Dose Part: Sham
n=10 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received 3 single intravitreal sham injection at week 1, 4 and 8.
|
Multiple Dose Part: High-dose BI 765128
n=23 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received 3 single intravitreal injection of high-dose BI 765128 at week 1, 4 and 8.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
68.7 Years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
50.7 Years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
63.8 Years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
52.0 Years
STANDARD_DEVIATION 15.5 • n=4 Participants
|
57.7 Years
STANDARD_DEVIATION 12.4 • n=21 Participants
|
57.5 Years
STANDARD_DEVIATION 13.0 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
38 Participants
n=8 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
|
0 Participants
n=8 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=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 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=8 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
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
40 Participants
n=8 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=8 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=8 Participants
|
PRIMARY outcome
Timeframe: From initial drug administration (day 1) until day 8.Population: Treated set (TS) - single rising dose part: all subjects who were treated with at least one dose of study drug.
Dose limiting events were defined in the clinical trial protocol as any of the following occurrences in the eye being studied during the evaluation period: * development of sterile endophthalmitis and/or sterile inflammation of the vitreous of 3+ (out of 0, 0.5+,1+,2+,3+ and 4+, where 0 is clear vitreous and 4+ is an obscured vitreous) according to the NEI (National Eye Institute) Grading of vitreous haze, and anterior chamber cells of 3+ (out of 0, 0.5+,1+,2+,3+ and 4+, where 0 is no inflammation and 4+ is severe inflammation) according to the Standardization of Uveitis Nomenclature (SUN) working group (WG) grading scheme for 5 or more days; * visual loss of more than 15 letters at any given time-point; persistent intra-ocular pressure over 30 mmHg for 3 days; * and signs of vascular occlusion in a first (the main branch) or second degree (the vessel after the first bifurcation of the main branch) retinal vessel.
Outcome measures
| Measure |
Single Rising Dose Part: Low-dose BI 765128
n=3 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of low-dose BI 765128.
|
Single Rising Dose Part: Medium-dose BI 765128
n=3 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of medium-dose BI 765128.
|
Single Rising Dose Part: High-dose BI 765128
n=6 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of high-dose BI 765128.
|
|---|---|---|---|
|
Single Rising Dose Part - Number of Subjects With Ocular Dose Limiting Events (DLEs) From Drug Administration Until Day 8 (7 Days After Treatment)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first drug administration to end of the multiple dose part of the study, i.e., up to day 141±7.Population: Treated set (TS) - multiple dose part: all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham).
Number of subjects with adverse events assessed as drug related by the investigator from first drug administration to end of the multiple dose part of the study.
Outcome measures
| Measure |
Single Rising Dose Part: Low-dose BI 765128
n=10 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of low-dose BI 765128.
|
Single Rising Dose Part: Medium-dose BI 765128
n=23 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of medium-dose BI 765128.
|
Single Rising Dose Part: High-dose BI 765128
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of high-dose BI 765128.
|
|---|---|---|---|
|
Multiple Dose Part - Number of Subjects With Drug Related Adverse Events (AEs) From Drug Administration Until End of Study (EOS)
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: From first drug administration to end of the single rising dose part of the study, i.e., up to day 99±7.Population: Treated set (TS) - single rising dose part: all subjects who were treated with at least one dose of study drug.
Number of subjects with adverse events assessed as drug related by the investigator from first drug administration to end of the single rising dose part of the study.
Outcome measures
| Measure |
Single Rising Dose Part: Low-dose BI 765128
n=3 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of low-dose BI 765128.
|
Single Rising Dose Part: Medium-dose BI 765128
n=3 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of medium-dose BI 765128.
|
Single Rising Dose Part: High-dose BI 765128
n=6 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of high-dose BI 765128.
|
|---|---|---|---|
|
Single Rising Dose Part - Number of Subjects With Drug Related Adverse Events (AEs) at End of Study (EOS)
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From first drug administration to end of the single rising dose part of the study, i.e., up to day 99±7.Population: Treated set (TS) - single rising dose part: all subjects who were treated with at least one dose of study drug.
Number of subjects with any ocular adverse events at the end of the single rising dose part of the study.
Outcome measures
| Measure |
Single Rising Dose Part: Low-dose BI 765128
n=3 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of low-dose BI 765128.
|
Single Rising Dose Part: Medium-dose BI 765128
n=3 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of medium-dose BI 765128.
|
Single Rising Dose Part: High-dose BI 765128
n=6 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of high-dose BI 765128.
|
|---|---|---|---|
|
Single Rising Dose Part - Number of Subjects With Any Ocular Adverse Events (AEs) (Eye Disorders) at End of Study (EOS)
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: MMRM included measurements at baseline, day 29±3, day 57±3, day 85±7, day 113±7 and day 141±7. Change from baseline values at day 85±7 (visit 5) is reported.Population: Treated set (TS) - multiple dose part: all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham). Only subjects with baseline and at least one on-treatment post baseline value were included in the analysis. Only subjects with measurements with scan quality index 6 or higher were included in the analysis.
This outcome measured the change in size of the foveal avascular zone (FAZ) from baseline to visit 5 of the multiple dose part of the trial by optical coherence tomography angiography (OCTA). Results were calculated as \[Visit 5\] -\[Baseline\]. A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.
Outcome measures
| Measure |
Single Rising Dose Part: Low-dose BI 765128
n=7 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of low-dose BI 765128.
|
Single Rising Dose Part: Medium-dose BI 765128
n=12 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of medium-dose BI 765128.
|
Single Rising Dose Part: High-dose BI 765128
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of high-dose BI 765128.
|
|---|---|---|---|
|
Multiple Dose Part - Change From Baseline of the Size of the Foveal Avascular Zone (FAZ) in Optical Coherence Tomography Angiography (OCTA) at Visit 5
|
0.0075 millimeter^2
Standard Error 0.0302
|
-0.0177 millimeter^2
Standard Error 0.0225
|
—
|
SECONDARY outcome
Timeframe: MMRM included measurements at baseline, day 29±3, day 57±3, day 85±7, day 113±7 and day 141±7. Change from baseline values at day 113±7 (visit 6) is reported.Population: Treated set (TS) - multiple dose part: all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham). Only subjects with baseline and at least one on-treatment post baseline value were included in the analysis. Only subjects with measurements with scan quality index 6 or higher were included in the analysis.
This outcome measured the change in size of the foveal avascular zone (FAZ) from baseline to visit 6 of the multiple dose part of the trial by optical coherence tomography angiography (OCTA). Results were calculated as \[Visit 6\] - \[Baseline\]. A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.
Outcome measures
| Measure |
Single Rising Dose Part: Low-dose BI 765128
n=8 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of low-dose BI 765128.
|
Single Rising Dose Part: Medium-dose BI 765128
n=12 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of medium-dose BI 765128.
|
Single Rising Dose Part: High-dose BI 765128
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of high-dose BI 765128.
|
|---|---|---|---|
|
Multiple Dose Part - Change From Baseline of the Size of the Foveal Avascular Zone (FAZ) in Optical Coherence Tomography Angiography (OCTA) at Visit 6
|
-0.0020 millimeter^2
Standard Error 0.0189
|
-0.0121 millimeter^2
Standard Error 0.0142
|
—
|
SECONDARY outcome
Timeframe: MMRM included measurements at baseline, day 29±3, day 57±3, day 85±7, day 113±7 and day 141±7. Change from baseline values at day 141±7 (visit 7) is reported.Population: Treated set (TS) - multiple dose part: all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham). Only subjects with baseline and at least one on-treatment post baseline value were included in the analysis. Only subjects with measurements with scan quality index 6 or higher were included in the analysis.
This outcome measured the change in size of the foveal avascular zone (FAZ) from baseline to visit 7 of the multiple dose part of the trial by optical coherence tomography angiography (OCTA). Results were calculated as \[Visit 7\] - \[Baseline\]. A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.
Outcome measures
| Measure |
Single Rising Dose Part: Low-dose BI 765128
n=8 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of low-dose BI 765128.
|
Single Rising Dose Part: Medium-dose BI 765128
n=11 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of medium-dose BI 765128.
|
Single Rising Dose Part: High-dose BI 765128
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of high-dose BI 765128.
|
|---|---|---|---|
|
Multiple Dose Part - Change From Baseline of the Size of the Foveal Avascular Zone (FAZ) in Optical Coherence Tomography Angiography (OCTA) at Visit 7
|
-0.0087 millimeter^2
Standard Error 0.0135
|
-0.0071 millimeter^2
Standard Error 0.0120
|
—
|
SECONDARY outcome
Timeframe: MMRM included measurements at baseline, day 29±3, day 57±3, day 85±7, day 113±7 and day 141±7. Change from baseline values at day 141±7 (visit 7) is reported.Population: Treated set (TS) - multiple dose part: all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham). Only subjects with baseline and at least one on-treatment post baseline value were included in the analysis.
This outcome measured the absolute change in best corrected visual acuity (BCVA) from baseline to visit 7 of the multiple dose part of the trial. The BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) visual acuity chart. The BCVA score was the number of letters read correctly by the patient. Results were calculated as \[Visit 7\] - \[Baseline\] and were rounded to one decimal place. A mixed model with repeated measurements (MMRM) was used for the analysis with fixed, categorical effects of treatment at each visit and the fixed continuous effects of baseline at each visit. Visit was treated as the repeated measure with an unstructured covariance structure used to model the within-patient measurements. The Kenward-Roger approximation was used to estimate denominator degrees of freedom and adjust standard errors.
Outcome measures
| Measure |
Single Rising Dose Part: Low-dose BI 765128
n=10 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of low-dose BI 765128.
|
Single Rising Dose Part: Medium-dose BI 765128
n=20 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of medium-dose BI 765128.
|
Single Rising Dose Part: High-dose BI 765128
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of high-dose BI 765128.
|
|---|---|---|---|
|
Multiple Dose Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 7
|
1.1 Number of letters
Standard Error 1.9
|
1.3 Number of letters
Standard Error 1.3
|
—
|
SECONDARY outcome
Timeframe: From first drug administration to end of the multiple dose part of the study, i.e., up to day 141±7.Population: Treated set (TS) - multiple dose part: all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham).
Number of subjects with any ocular adverse events at the end of the multiple dose part of the study.
Outcome measures
| Measure |
Single Rising Dose Part: Low-dose BI 765128
n=10 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of low-dose BI 765128.
|
Single Rising Dose Part: Medium-dose BI 765128
n=23 Participants
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of medium-dose BI 765128.
|
Single Rising Dose Part: High-dose BI 765128
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of high-dose BI 765128.
|
|---|---|---|---|
|
Multiple Dose Part - Number of Subjects With Any Ocular Adverse Events (AEs) (Eye Disorders) From Drug Administration Until End of Study (EOS)
|
3 Participants
|
9 Participants
|
—
|
Adverse Events
Single Rising Dose Part: Low-dose BI 765128
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Single Rising Dose Part: Medium-dose BI 765128
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Single Rising Dose Part: High-dose BI 765128
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Multiple Dose Part: Sham
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Multiple Dose Part: High-dose BI 765128
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Rising Dose Part: Low-dose BI 765128
n=3 participants at risk
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of low-dose BI 765128.
|
Single Rising Dose Part: Medium-dose BI 765128
n=3 participants at risk
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of medium-dose BI 765128.
|
Single Rising Dose Part: High-dose BI 765128
n=6 participants at risk
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of high-dose BI 765128.
|
Multiple Dose Part: Sham
n=10 participants at risk
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received 3 single intravitreal sham injection at week 1, 4 and 8.
|
Multiple Dose Part: High-dose BI 765128
n=23 participants at risk
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received 3 single intravitreal injection of high-dose BI 765128 at week 1, 4 and 8.
|
|---|---|---|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
10.0%
1/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
10.0%
1/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
4.3%
1/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
4.3%
1/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Nervous system disorders
Cerebrovascular accident
|
33.3%
1/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
4.3%
1/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
4.3%
1/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
4.3%
1/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
4.3%
1/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
Other adverse events
| Measure |
Single Rising Dose Part: Low-dose BI 765128
n=3 participants at risk
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of low-dose BI 765128.
|
Single Rising Dose Part: Medium-dose BI 765128
n=3 participants at risk
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of medium-dose BI 765128.
|
Single Rising Dose Part: High-dose BI 765128
n=6 participants at risk
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received one single intravitreal injection of high-dose BI 765128.
|
Multiple Dose Part: Sham
n=10 participants at risk
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received 3 single intravitreal sham injection at week 1, 4 and 8.
|
Multiple Dose Part: High-dose BI 765128
n=23 participants at risk
Diabetic retinopathy (DR) patients with Diabetic Macular Ischemia (DMI) previously treated with panretinal photocoagulation (PRP) received 3 single intravitreal injection of high-dose BI 765128 at week 1, 4 and 8.
|
|---|---|---|---|---|---|
|
Eye disorders
Blepharitis
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
10.0%
1/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
16.7%
1/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
10.0%
1/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
33.3%
1/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
10.0%
1/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
10.0%
1/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
13.0%
3/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
16.7%
1/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
10.0%
1/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Infections and infestations
Cellulitis
|
33.3%
1/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
16.7%
1/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Investigations
Blood pressure increased
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
10.0%
1/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Investigations
Blood urine present
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
10.0%
1/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Investigations
Glucose urine present
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
10.0%
1/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
10.0%
1/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Investigations
Heart rate increased
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
10.0%
1/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Investigations
Lipase increased
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
10.0%
1/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Investigations
Urine ketone body present
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
10.0%
1/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
10.0%
1/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
10.0%
1/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
16.7%
1/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/3 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
16.7%
1/6 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/10 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
0.00%
0/23 • Single rising dose part: From first drug administration to end of study, i.e., up to day 99±7. Multiple dose part: From first drug administration to end of study, i.e., up to day 141±7.
Treated set (TS) - all subjects who were treated with at least one dose of study drug in the single rising dose part and all subjects who were randomized and treated with at least one dose of study drug (either treatment with BI 765128 or Sham) in the multiple dose part.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER