Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM (Nangibotide) in Patients With Septic Shock (NCT NCT03158948)
NCT ID: NCT03158948
Last Updated: 2024-10-08
Results Overview
Analyses were performed in the Safety Set composed of all randomized patients who received at least any dose of the study drug (nangibotide or placebo). Adverse events: Summary statistics of treatment emergent adverse events (TEAEs). Clinical events, including death, related to severe sepsis and sepsis complications were exempt from SAE reporting, unless the investigator deemed the event to be related to the administration of the study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Adverse events experienced until D28 (End of study visit)
Results posted on
2024-10-08
Participant Flow
Patients were enrolled from 03 July 2017 (first patient first visit) to 11 June 2018 (last patient last visit) in 11 centers in 4 countries (Belgium, France, Spain, The Netherlands). 50 patients were included and randomized. 49 (98.0%) patients received the IMP and one patient died before IMP administration.
The duration of this study for each patient was a maximum of 13 weeks (including screening, up to 5 days of treatment and follow-up assessments 28 and 90 days after randomization). The purpose of the screening phase was to confirm patient eligibility for enrolment in the study based on the inclusion and exclusion criteria and to obtain written ICF.
Participant milestones
| Measure |
Nangibotide 0.3 mg/kg/h
Nangibotide was administered as 5 mg/kg loading dose over 15 minutes followed by a continuous intravenous (i.v.) infusion at the dosage of 0.3 mg/kg/h for up to 5 days.
MOTREM: 0.3 mg/kg/h Formulated LR12 peptide
|
Nangibotide 1.0 mg/kg/h
Nangibotide was administered as 5 mg/kg loading dose over 15 minutes followed by a continuous intravenous (i.v.) infusion at the dosage of 1.0 mg/kg/h for up to 5 days.
MOTREM: 1 mg/kg/hr Formulated LR12 peptide
|
Nangibotide 3.0 mg/kg/h
Nangibotide was administered as 5 mg/kg loading dose over 15 minutes followed by a continuous intravenous (i.v.) infusion at the dosage of 3.0 mg/kg/h for up to 5 days.
MOTREM: 3 mg/kg/h Formulated LR12 peptide
|
Placebo
Placebo: placebo The matching placebo (solution of NaCl 0.9%) was administered as 5 mg/kg loading dose over 15 minutes followed by a continuous intravenous (i.v.) infusion at the dosage of 0.3 mg/kg/h for up to 5 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
11
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
3
|
Reasons for withdrawal
| Measure |
Nangibotide 0.3 mg/kg/h
Nangibotide was administered as 5 mg/kg loading dose over 15 minutes followed by a continuous intravenous (i.v.) infusion at the dosage of 0.3 mg/kg/h for up to 5 days.
MOTREM: 0.3 mg/kg/h Formulated LR12 peptide
|
Nangibotide 1.0 mg/kg/h
Nangibotide was administered as 5 mg/kg loading dose over 15 minutes followed by a continuous intravenous (i.v.) infusion at the dosage of 1.0 mg/kg/h for up to 5 days.
MOTREM: 1 mg/kg/hr Formulated LR12 peptide
|
Nangibotide 3.0 mg/kg/h
Nangibotide was administered as 5 mg/kg loading dose over 15 minutes followed by a continuous intravenous (i.v.) infusion at the dosage of 3.0 mg/kg/h for up to 5 days.
MOTREM: 3 mg/kg/h Formulated LR12 peptide
|
Placebo
Placebo: placebo The matching placebo (solution of NaCl 0.9%) was administered as 5 mg/kg loading dose over 15 minutes followed by a continuous intravenous (i.v.) infusion at the dosage of 0.3 mg/kg/h for up to 5 days.
|
|---|---|---|---|---|
|
Overall Study
Death
|
1
|
1
|
3
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 3 Doses of MOTREM (Nangibotide) in Patients With Septic Shock
Baseline characteristics by cohort
| Measure |
Nangibotide 0.3 mg/kg/h
n=13 Participants
Nangibotide: 0.3 mg/kg Formulated LR12 peptide
|
Nangibotide 1.0 mg/kg/h
n=12 Participants
Nangibotide: 1 mg/kg Formulated LR12 peptide
|
Nangibotide 3.0 mg/kg/h
n=12 Participants
Nangibotide: 3 mg/kg Formulated LR12 peptide
|
Placebo
n=12 Participants
Placebo: placebo
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age≤65
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Age, Customized
Age>65
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Weight
|
75.0 kg
n=5 Participants
|
76.5 kg
n=7 Participants
|
68.0 kg
n=5 Participants
|
77.0 kg
n=4 Participants
|
74.0 kg
n=21 Participants
|
|
Height
|
168.0 cm
n=5 Participants
|
168.5 cm
n=7 Participants
|
165.0 cm
n=5 Participants
|
167.5 cm
n=4 Participants
|
167.0 cm
n=21 Participants
|
|
BMI
|
24.8 kg/m^2
n=5 Participants
|
26.0 kg/m^2
n=7 Participants
|
25.1 kg/m^2
n=5 Participants
|
27.5 kg/m^2
n=4 Participants
|
26.1 kg/m^2
n=21 Participants
|
PRIMARY outcome
Timeframe: Adverse events experienced until D28 (End of study visit)Population: Out of 49 patients included in all 4 groups, TEAEs were observed for 45 patients (12 patients experienced TEAEs in MOTREM 1 group, 12 patients experienced TEAEs in MOTREM 2 group, 11 patients experienced TEAEs in MOTREM 3 group and 10 patients experienced TEAEs in placebo group)
Analyses were performed in the Safety Set composed of all randomized patients who received at least any dose of the study drug (nangibotide or placebo). Adverse events: Summary statistics of treatment emergent adverse events (TEAEs). Clinical events, including death, related to severe sepsis and sepsis complications were exempt from SAE reporting, unless the investigator deemed the event to be related to the administration of the study drug.
Outcome measures
| Measure |
Nangibotide 0.3 mg/kg/h
n=13 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 1.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 3.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Placebo
n=12 Participants
Placebo: placebo
|
|---|---|---|---|---|
|
Number of Patients Experiencing Treatment Emergent Adverse Events From Screening Until Study Completion
|
12 Participants
|
12 Participants
|
11 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28).Population: The data is not available for all subjects and the data in the tables below refers to only those participants who were measured and analyzed. Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Mean Arterial Pressure (mmHg), heart rate (bpm) and temperature in Celsius degrees were described at each time when it was available: D1, D2, D3, D4, D5 and EOS visit.
Systolic blood pressure measured by sphygmomanometer at study site. Median SBP at each visit is summarized by treatment group.
Outcome measures
| Measure |
Nangibotide 0.3 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 1.0 mg/kg/h
n=13 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 3.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Placebo
n=12 Participants
Placebo: placebo
|
|---|---|---|---|---|
|
Systolic Blood Pressure (SBP)
D1
|
114.5 mmHg
Interval 82.0 to 131.0
|
117.0 mmHg
Interval 96.0 to 159.0
|
112.5 mmHg
Interval 93.0 to 124.0
|
113.0 mmHg
Interval 97.0 to 150.0
|
|
Systolic Blood Pressure (SBP)
D0
|
121.5 mmHg
Interval 87.0 to 149.0
|
110.0 mmHg
Interval 90.0 to 133.0
|
121.0 mmHg
Interval 96.0 to 131.0
|
111.0 mmHg
Interval 87.0 to 160.0
|
|
Systolic Blood Pressure (SBP)
D2
|
107.0 mmHg
Interval 104.0 to 110.0
|
116.0 mmHg
Interval 96.0 to 147.0
|
121.0 mmHg
Interval 105.0 to 130.0
|
112.0 mmHg
Interval 100.0 to 150.0
|
|
Systolic Blood Pressure (SBP)
D3
|
94.0 mmHg
Interval 87.0 to 101.0
|
126.5 mmHg
Interval 124.0 to 129.0
|
108.5 mmHg
Interval 96.0 to 127.0
|
112.5 mmHg
Interval 102.0 to 123.0
|
|
Systolic Blood Pressure (SBP)
D4
|
108.0 mmHg
Interval 104.0 to 112.0
|
133.0 mmHg
Interval 133.0 to 133.0
|
105.0 mmHg
Interval 101.0 to 125.0
|
107.0 mmHg
Interval 95.0 to 119.0
|
|
Systolic Blood Pressure (SBP)
D5/EOI
|
117.0 mmHg
Interval 80.0 to 137.0
|
118.0 mmHg
Interval 94.0 to 180.0
|
114.5 mmHg
Interval 99.0 to 170.0
|
109.0 mmHg
Interval 79.0 to 131.0
|
|
Systolic Blood Pressure (SBP)
D28/EOS
|
135.0 mmHg
Interval 107.0 to 181.0
|
120.0 mmHg
Interval 90.0 to 140.0
|
111.0 mmHg
Interval 95.0 to 166.0
|
113.0 mmHg
Interval 93.0 to 120.0
|
PRIMARY outcome
Timeframe: Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28).Population: The data is not available for all subjects and the data in the tables below refers to only those participants who were measured and analyzed. Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Mean Arterial Pressure (mmHg), heart rate (bpm) and temperature in Celsius degrees were described at each time when it was available: D1, D2, D3, D4, D5 and EOS visit.
Median DBP at each visit is summarized by treatment group.
Outcome measures
| Measure |
Nangibotide 0.3 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 1.0 mg/kg/h
n=13 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 3.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Placebo
n=12 Participants
Placebo: placebo
|
|---|---|---|---|---|
|
Diastolic Blood Pressure (DBP)
D0
|
53.5 mmHg
Interval 44.0 to 77.0
|
55.0 mmHg
Interval 40.0 to 78.0
|
59.0 mmHg
Interval 49.0 to 78.0
|
55.5 mmHg
Interval 44.0 to 72.0
|
|
Diastolic Blood Pressure (DBP)
D1
|
59.0 mmHg
Interval 45.0 to 72.0
|
55.0 mmHg
Interval 32.0 to 75.0
|
59.5 mmHg
Interval 48.0 to 128.0
|
58.0 mmHg
Interval 44.0 to 75.0
|
|
Diastolic Blood Pressure (DBP)
D2
|
61.0 mmHg
Interval 56.0 to 66.0
|
63.5 mmHg
Interval 61.0 to 75.0
|
66.0 mmHg
Interval 58.0 to 72.0
|
67.0 mmHg
Interval 47.0 to 86.0
|
|
Diastolic Blood Pressure (DBP)
D3
|
58.5 mmHg
Interval 50.0 to 67.0
|
60.5 mmHg
Interval 60.0 to 61.0
|
55.5 mmHg
Interval 40.0 to 62.0
|
62.0 mmHg
Interval 46.0 to 70.0
|
|
Diastolic Blood Pressure (DBP)
D4
|
61.5 mmHg
Interval 55.0 to 68.0
|
64.0 mmHg
Interval 64.0 to 64.0
|
55.0 mmHg
Interval 52.0 to 56.0
|
58.0 mmHg
Interval 46.0 to 63.0
|
|
Diastolic Blood Pressure (DBP)
D5/EOI
|
55.5 mmHg
Interval 46.0 to 63.0
|
58.0 mmHg
Interval 38.0 to 95.0
|
57.0 mmHg
Interval 44.0 to 81.0
|
57.0 mmHg
Interval 30.0 to 71.0
|
|
Diastolic Blood Pressure (DBP)
D28/EOS
|
70.0 mmHg
Interval 40.0 to 82.0
|
70.0 mmHg
Interval 35.0 to 90.0
|
60.0 mmHg
Interval 45.0 to 80.0
|
65.0 mmHg
Interval 60.0 to 80.0
|
PRIMARY outcome
Timeframe: Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5) and on final study day at day 28 (D28).Population: The data is not available for all subjects and the data in the tables below refers to only those participants who were measured and analyzed. Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Mean Arterial Pressure (mmHg), heart rate (bpm) and temperature in Celsius degrees were described at each time when it was available: D1, D2, D3, D4, D5 and EOS visit.
MAP at each visit is summarized by treatment group.
Outcome measures
| Measure |
Nangibotide 0.3 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 1.0 mg/kg/h
n=13 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 3.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Placebo
n=12 Participants
Placebo: placebo
|
|---|---|---|---|---|
|
Median Arterial Pressure (MAP)
D0
|
72.0 mmHg
Interval 61.0 to 101.0
|
71.0 mmHg
Interval 60.0 to 98.0
|
78.0 mmHg
Interval 67.0 to 96.0
|
73.0 mmHg
Interval 61.0 to 116.0
|
|
Median Arterial Pressure (MAP)
D1
|
77.5 mmHg
Interval 57.0 to 92.0
|
76.0 mmHg
Interval 60.0 to 97.0
|
74.0 mmHg
Interval 55.0 to 87.0
|
77.0 mmHg
Interval 65.0 to 100.0
|
|
Median Arterial Pressure (MAP)
D2
|
76.0 mmHg
Interval 69.0 to 83.0
|
82.5 mmHg
Interval 77.0 to 105.0
|
80.0 mmHg
Interval 55.0 to 90.0
|
80.0 mmHg
Interval 67.0 to 98.0
|
|
Median Arterial Pressure (MAP)
D3
|
71.0 mmHg
Interval 62.0 to 80.0
|
84.5 mmHg
Interval 84.0 to 85.0
|
72.5 mmHg
Interval 54.0 to 83.0
|
79.0 mmHg
Interval 70.0 to 88.0
|
|
Median Arterial Pressure (MAP)
D4
|
76.5 mmHg
Interval 69.0 to 84.0
|
92.0 mmHg
Interval 92.0 to 92.0
|
71.0 mmHg
Interval 69.0 to 74.0
|
77.0 mmHg
Interval 70.0 to 79.0
|
|
Median Arterial Pressure (MAP)
D5/EOI
|
75.0 mmHg
Interval 58.0 to 82.0
|
78.0 mmHg
Interval 61.0 to 130.0
|
76.0 mmHg
Interval 59.0 to 112.0
|
72.5 mmHg
Interval 41.0 to 90.0
|
|
Median Arterial Pressure (MAP)
D28/EOS
|
87.0 mmHg
Interval 62.0 to 99.0
|
86.5 mmHg
Interval 52.0 to 106.0
|
74.0 mmHg
Interval 59.0 to 107.0
|
79.0 mmHg
Interval 66.0 to 93.0
|
PRIMARY outcome
Timeframe: Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5).Population: The data is not available for all subjects and the data in the tables below refers to only those participants who were measured and analyzed. systolic blood pressure (mmHg). Diastolic blood pressure (mmHg), mean arterial pressure (mmHg), heart rate (bpm) and temperature i celcius degrees were described at each time when it was available: D0, D1, D2, D3, D4 and D5/EOI visit.
Median heart rate at each visit is summarized by treatment group.
Outcome measures
| Measure |
Nangibotide 0.3 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 1.0 mg/kg/h
n=13 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 3.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Placebo
n=12 Participants
Placebo: placebo
|
|---|---|---|---|---|
|
Heart Rate
D0
|
83.5 bpm
Interval 54.0 to 136.0
|
94.0 bpm
Interval 75.0 to 138.0
|
104.5 bpm
Interval 66.0 to 136.0
|
97.5 bpm
Interval 85.0 to 147.0
|
|
Heart Rate
D1
|
89.0 bpm
Interval 58.0 to 145.0
|
86.0 bpm
Interval 70.0 to 135.0
|
91.0 bpm
Interval 65.0 to 131.0
|
98.0 bpm
Interval 77.0 to 135.0
|
|
Heart Rate
D2
|
74.0 bpm
Interval 60.0 to 88.0
|
85.0 bpm
Interval 80.0 to 105.0
|
110.0 bpm
Interval 92.0 to 132.0
|
83.0 bpm
Interval 58.0 to 153.0
|
|
Heart Rate
D3
|
95.0 bpm
Interval 70.0 to 120.0
|
60.5 bpm
Interval 58.0 to 63.0
|
102.5 bpm
Interval 61.0 to 121.0
|
88.5 bpm
Interval 64.0 to 100.0
|
|
Heart Rate
D4
|
75.0 bpm
Interval 70.0 to 80.0
|
61.0 bpm
Interval 61.0 to 61.0
|
121.0 bpm
Interval 100.0 to 156.0
|
84.5 bpm
Interval 66.0 to 96.0
|
|
Heart Rate
D5/EOI
|
86.0 bpm
Interval 67.0 to 129.0
|
91.0 bpm
Interval 55.0 to 133.0
|
93.5 bpm
Interval 58.0 to 112.0
|
91.0 bpm
Interval 70.0 to 122.0
|
PRIMARY outcome
Timeframe: Vital signs were assessed each day from day zero (D0 [before investigational medicinal product initiation]) to end of infusion at day 5 (D5).Population: The data is not available for all subjects and the data in the tables below refers to only those participants who were measured and analyzed. Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Mean Arterial Pressure (mmHg), heart rate (bpm) and temperature in Celsius degrees were described at each time when it was available: D0, D1, D2, D3, D4, D5/EOI visit.
Median temperature at each visit is summarized by treatment group.
Outcome measures
| Measure |
Nangibotide 0.3 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 1.0 mg/kg/h
n=13 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 3.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Placebo
n=12 Participants
Placebo: placebo
|
|---|---|---|---|---|
|
Temperature
D0
|
37.3 °C
Interval 35.0 to 38.9
|
36.8 °C
Interval 35.7 to 38.9
|
37.0 °C
Interval 35.8 to 38.5
|
37.0 °C
Interval 34.0 to 39.6
|
|
Temperature
D1
|
36.3 °C
Interval 35.5 to 40.8
|
36.2 °C
Interval 33.5 to 39.3
|
36.8 °C
Interval 36.0 to 38.0
|
37.1 °C
Interval 35.7 to 38.8
|
|
Temperature
D2
|
36.1 °C
Interval 35.5 to 36.6
|
36.3 °C
Interval 35.7 to 37.0
|
36.5 °C
Interval 36.0 to 37.4
|
37.4 °C
Interval 35.1 to 38.9
|
|
Temperature
D3
|
36.6 °C
Interval 36.0 to 37.1
|
36.3 °C
Interval 35.6 to 36.9
|
36.7 °C
Interval 36.1 to 37.8
|
37.4 °C
Interval 36.1 to 38.2
|
|
Temperature
D4
|
36.1 °C
Interval 36.0 to 36.2
|
36.1 °C
Interval 36.1 to 36.1
|
36.9 °C
Interval 36.6 to 37.4
|
36.6 °C
Interval 36.3 to 37.3
|
|
Temperature
D5/EOI
|
36.9 °C
Interval 35.8 to 37.3
|
36.2 °C
Interval 35.6 to 37.9
|
36.5 °C
Interval 35.4 to 38.6
|
36.4 °C
Interval 34.3 to 38.3
|
PRIMARY outcome
Timeframe: Electrocardiogram was performed each day from D0 (before IMP initiation) to D5 (EOI) and on D28 (EOS).Population: Some patients did not perform ECG at some visits
Abnormal and emergent clinically significant electrocardiogram were summarized for each group.
Outcome measures
| Measure |
Nangibotide 0.3 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 1.0 mg/kg/h
n=13 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 3.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Placebo
n=12 Participants
Placebo: placebo
|
|---|---|---|---|---|
|
Electrocardiogram
ECG - D2 · ECGs - Abnormal CS
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Electrocardiogram
ECG - D2 · ECGs - Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Electrocardiogram
ECG - D5/EOI · ECGs - Abnormal NCS
|
4 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
|
Electrocardiogram
ECG - D28/EOS · ECGs - Abnormal NCS
|
5 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
|
Electrocardiogram
ECG - D28/EOS · ECGs - Abnormal CS
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Electrocardiogram
ECG - D28/EOS · ECGs - Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Electrocardiogram
ECG - D1 · ECGs - Normal
|
4 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Electrocardiogram
ECG - D1 · ECGs - Abnormal NCS
|
3 Participants
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Electrocardiogram
ECG - D1 · ECGs - Abnormal CS
|
5 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Electrocardiogram
ECG - D1 · ECGs - Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Electrocardiogram
ECG - D2 · ECGs - Normal
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Electrocardiogram
ECG - D2 · ECGs - Abnormal NCS
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Electrocardiogram
ECG - D3 · ECGs - Normal
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Electrocardiogram
ECG - D3 · ECGs - Abnormal NCS
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Electrocardiogram
ECG - D3 · ECGs - Abnormal CS
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Electrocardiogram
ECG - D3 · ECGs - Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Electrocardiogram
ECG - D4 · ECGs - Normal
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Electrocardiogram
ECG - D4 · ECGs - Abnormal NCS
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Electrocardiogram
ECG - D4 · ECGs - Abnormal CS
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Electrocardiogram
ECG - D4 · ECGs - Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Electrocardiogram
ECG - D5/EOI · ECGs - Normal
|
3 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Electrocardiogram
ECG - D5/EOI · ECGs - Abnormal CS
|
2 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Electrocardiogram
ECG - D5/EOI · ECGs - Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Electrocardiogram
ECG - D28/EOS · ECGs - Normal
|
3 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Anti-Drug Antibodies test were done at D0, D10 and D28 in all patients.Anti-Drug Antibodies test was performed for all patients.
Outcome measures
| Measure |
Nangibotide 0.3 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 1.0 mg/kg/h
n=13 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 3.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Placebo
n=12 Participants
Placebo: placebo
|
|---|---|---|---|---|
|
Anti-Drug Antibodies (ADA Dimer)
D0 · MISSING
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anti-Drug Antibodies (ADA Dimer)
D0 · NEGATIVE
|
12 Participants
|
13 Participants
|
12 Participants
|
12 Participants
|
|
Anti-Drug Antibodies (ADA Dimer)
D0 · POSITIVE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anti-Drug Antibodies (ADA Dimer)
D10 · MISSING
|
11 Participants
|
13 Participants
|
9 Participants
|
7 Participants
|
|
Anti-Drug Antibodies (ADA Dimer)
D10 · NEGATIVE
|
1 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
|
Anti-Drug Antibodies (ADA Dimer)
D10 · POSITIVE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anti-Drug Antibodies (ADA Dimer)
D28 · MISSING
|
3 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Anti-Drug Antibodies (ADA Dimer)
D28 · NEGATIVE
|
9 Participants
|
9 Participants
|
10 Participants
|
9 Participants
|
|
Anti-Drug Antibodies (ADA Dimer)
D28 · POSITIVE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Anti-Drug Antibodies test were measured at D0, D10 and D28.Population: The results are presented for the Day 28.
Anti-Drug Antibodies test was performed for all patients.
Outcome measures
| Measure |
Nangibotide 0.3 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 1.0 mg/kg/h
n=13 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 3.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Placebo
n=12 Participants
Placebo: placebo
|
|---|---|---|---|---|
|
Anti-Drug Antibodies (ADA Monomer)
D0 · MISSING
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anti-Drug Antibodies (ADA Monomer)
D0 · NEGATIVE
|
12 Participants
|
13 Participants
|
12 Participants
|
12 Participants
|
|
Anti-Drug Antibodies (ADA Monomer)
D0 · POSITIVE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anti-Drug Antibodies (ADA Monomer)
D10 · MISSING
|
11 Participants
|
13 Participants
|
9 Participants
|
7 Participants
|
|
Anti-Drug Antibodies (ADA Monomer)
D10 · NEGATIVE
|
1 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
|
Anti-Drug Antibodies (ADA Monomer)
D10 · POSITIVE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Anti-Drug Antibodies (ADA Monomer)
D28 · MISSING
|
3 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Anti-Drug Antibodies (ADA Monomer)
D28 · NEGATIVE
|
9 Participants
|
8 Participants
|
10 Participants
|
9 Participants
|
|
Anti-Drug Antibodies (ADA Monomer)
D28 · POSITIVE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOIAs no pharmacokinetic sample was planned just after the loading dose, maximum observed nangibotide plasma concentration (Cmax) was in the same magnitude as steady-state concentration during the maintenance infusion, calculated as the median of the observed pre-dose concentration from day2 onwards up to the last pre-dose concentration available in the study (Cavg).
Outcome measures
| Measure |
Nangibotide 0.3 mg/kg/h
n=13 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 1.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 3.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Placebo
Placebo: placebo
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters From the Non-compartmental Analysis: Cmax
|
71.2 ng/mL
Interval 20.0 to 219.0
|
234 ng/mL
Interval 71.3 to 514.0
|
914 ng/mL
Interval 502.0 to 6095.0
|
—
|
SECONDARY outcome
Timeframe: Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOITime to reach the maximum observed nangibotide plasma concentration (h) was measured for all groups.
Outcome measures
| Measure |
Nangibotide 0.3 mg/kg/h
n=13 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 1.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 3.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Placebo
Placebo: placebo
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters From the Non-compartmental Analysis: Tmax
|
22.7 h
Interval 14.3 to 76.0
|
25.4 h
Interval 9.25 to 118.0
|
36.0 h
Interval 9.0 to 75.8
|
—
|
SECONDARY outcome
Timeframe: Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOIArea under the plasma concentration-time curve from time 0 to the last quantifiable concentration Clast was calculated using the log-linear trapezoidal method.
Outcome measures
| Measure |
Nangibotide 0.3 mg/kg/h
n=13 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 1.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 3.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Placebo
Placebo: placebo
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters From the Non-compartmental Analysis: AUC0-last
|
1722 ng*h/mL
Interval 360.0 to 5243.0
|
7579 ng*h/mL
Interval 668.0 to 45189.0
|
47320 ng*h/mL
Interval 3830.0 to 393506.0
|
—
|
SECONDARY outcome
Timeframe: Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOISteady-state concentration during the maintenance infusion was calculated as the median of the observed pre-dose concentration from day2 onwards up to the last pre-dose concentration available in the study.
Outcome measures
| Measure |
Nangibotide 0.3 mg/kg/h
n=13 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 1.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 3.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Placebo
Placebo: placebo
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters From the Non-compartmental Analysis: Cavg
|
67.6 ng/mL
Interval 20.0 to 219.0
|
223 ng/mL
Interval 71.3 to 418.0
|
729 ng/mL
Interval 93.9 to 3778.0
|
—
|
SECONDARY outcome
Timeframe: Baseline: pre-dose sample at Day 0 (D0) Daily up to Day 5 (D5) (or the last day in the study/EOI) If possible, at D5/EOI: - 15 min before end of infusion (EOI) - 10 min after EOI - 30 min after EOI - 2h after EOISystemic clearance was calculated as the ratio between the infusion rate during the maintenance infusion and Cavg.
Outcome measures
| Measure |
Nangibotide 0.3 mg/kg/h
n=13 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 1.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Nangibotide 3.0 mg/kg/h
n=12 Participants
Nangibotide: Formulated LR12 peptide
|
Placebo
Placebo: placebo
|
|---|---|---|---|---|
|
Pharmacokinetic Parameters From the Non-compartmental Analysis: CL
|
4.52 L/h/kg
Interval 1.36 to 15.3
|
4.50 L/h/kg
Interval 2.39 to 14.0
|
4.12 L/h/kg
Interval 0.794 to 25.0
|
—
|
Adverse Events
Placebo
Serious events: 7 serious events
Other events: 10 other events
Deaths: 3 deaths
Nangibotide 0.3 mg/kg/h
Serious events: 4 serious events
Other events: 12 other events
Deaths: 4 deaths
Nangibotide 1.0 mg/kg/h
Serious events: 2 serious events
Other events: 12 other events
Deaths: 2 deaths
Nangibotide 3.0 mg/kg/h
Serious events: 4 serious events
Other events: 11 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Placebo
n=12 participants at risk
Placebo: placebo
|
Nangibotide 0.3 mg/kg/h
n=13 participants at risk
MOTREM: Formulated LR12 peptide
|
Nangibotide 1.0 mg/kg/h
n=12 participants at risk
MOTREM: Formulated LR12 peptide
|
Nangibotide 3.0 mg/kg/h
n=12 participants at risk
MOTREM: Formulated LR12 peptide
|
|---|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Infections and infestations
Pneumonia
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
7.7%
1/13 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Infections and infestations
Septic shock
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
7.7%
1/13 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
7.7%
1/13 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
7.7%
1/13 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
7.7%
1/13 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
General disorders
Multiple organ failure syndrome
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Vascular disorders
Haemodynamic instability
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Infections and infestations
Cardiac infection
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Injury, poisoning and procedural complications
Mechanical ventilation complication
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Vascular disorders
Shock
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Cardiac disorders
Acute coronary syndrome
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Nervous system disorders
Epilepsy
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Cardiac disorders
Sinus tachycardia
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory fatigue
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
Other adverse events
| Measure |
Placebo
n=12 participants at risk
Placebo: placebo
|
Nangibotide 0.3 mg/kg/h
n=13 participants at risk
MOTREM: Formulated LR12 peptide
|
Nangibotide 1.0 mg/kg/h
n=12 participants at risk
MOTREM: Formulated LR12 peptide
|
Nangibotide 3.0 mg/kg/h
n=12 participants at risk
MOTREM: Formulated LR12 peptide
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
3/12 • Number of events 3 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
23.1%
3/13 • Number of events 3 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
16.7%
2/12 • Number of events 2 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
25.0%
3/12 • Number of events 3 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Cardiac disorders
Atrial fibrillation
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
38.5%
5/13 • Number of events 5 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
16.7%
2/12 • Number of events 2 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
25.0%
3/12 • Number of events 3 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
16.7%
2/12 • Number of events 2 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
7.7%
1/13 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
16.7%
2/12 • Number of events 2 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
16.7%
2/12 • Number of events 2 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
33.3%
4/12 • Number of events 4 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
16.7%
2/12 • Number of events 2 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
16.7%
2/12 • Number of events 2 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
7.7%
1/13 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
25.0%
3/12 • Number of events 3 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Nervous system disorders
Confusional State
|
16.7%
2/12 • Number of events 2 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
16.7%
2/12 • Number of events 2 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
16.7%
2/12 • Number of events 2 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
16.7%
2/12 • Number of events 2 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
16.7%
2/12 • Number of events 2 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Gastrointestinal disorders
Intra-Abdominal Fluid Collection
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
7.7%
1/13 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
16.7%
2/12 • Number of events 2 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Infections and infestations
Oral Fungal Infection
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
7.7%
1/13 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
16.7%
2/12 • Number of events 2 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Psychiatric disorders
Agitation
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
16.7%
2/12 • Number of events 2 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Vascular disorders
Hypotension
|
16.7%
2/12 • Number of events 3 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/13 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Infections and infestations
Infectious Pleural Effusion
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
7.7%
1/13 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
16.7%
2/12 • Number of events 2 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
15.4%
2/13 • Number of events 2 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Renal and urinary disorders
Renal Failure
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
7.7%
1/13 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
|
Infections and infestations
Septic Shock
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
7.7%
1/13 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
0.00%
0/12 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
8.3%
1/12 • Number of events 1 • From baseline until D28
All deaths, Serious Adverse Events, and Other Adverse Events are reported in the Adverse Event module.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place