Trial Outcomes & Findings for A Phase 1b/2a Study of the Safety and Pharmacokinetics of Rhu-plasma Gelsolin in Hospitalized Subjects With CAP (NCT NCT03466073)
NCT ID: NCT03466073
Last Updated: 2020-01-27
Results Overview
Treatment emergent adverse events were all adverse events (AEs) that occurred subsequent to enrollment. The seriousness of adverse events was judged by the site investigator.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
33 participants
Primary outcome timeframe
0-28 days
Results posted on
2020-01-27
Participant Flow
Participant milestones
| Measure |
6 mg/kg Rhu-pGSN Single Dose
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care
|
Placebo Single Dose
Intravenous administration of placebo (NSS) in addition to standard of care
|
6 mg/kg Rhu-pGSN Multiple Ascending Dose
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care once a day for 3 consecutive days
|
12 mg/kg Rhu-pGSN Multiple Ascending Dose
Intravenous administration of recombinant human plasma gelsolin at 12 mg/kg in addition to standard of care once a day for 3 consecutive days
|
24 mg/kg Rhu-pGSN Multiple Ascending Dose
Intravenous administration of recombinant human plasma gelsolin at 24 mg/kg in addition to standard of care once a day for 3 consecutive days
|
Placebo Multiple Ascending Dose
Intravenous administration of placebo (NSS) in addition to standard of care once a day for 3 consecutive days
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
6
|
6
|
6
|
7
|
|
Overall Study
COMPLETED
|
5
|
2
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
6 mg/kg Rhu-pGSN Single Dose
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care
|
Placebo Single Dose
Intravenous administration of placebo (NSS) in addition to standard of care
|
6 mg/kg Rhu-pGSN Multiple Ascending Dose
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care once a day for 3 consecutive days
|
12 mg/kg Rhu-pGSN Multiple Ascending Dose
Intravenous administration of recombinant human plasma gelsolin at 12 mg/kg in addition to standard of care once a day for 3 consecutive days
|
24 mg/kg Rhu-pGSN Multiple Ascending Dose
Intravenous administration of recombinant human plasma gelsolin at 24 mg/kg in addition to standard of care once a day for 3 consecutive days
|
Placebo Multiple Ascending Dose
Intravenous administration of placebo (NSS) in addition to standard of care once a day for 3 consecutive days
|
|---|---|---|---|---|---|---|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Phase 1b/2a Study of the Safety and Pharmacokinetics of Rhu-plasma Gelsolin in Hospitalized Subjects With CAP
Baseline characteristics by cohort
| Measure |
6 mg/kg Rhu-pGSN Single Dose
n=6 Participants
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care
|
Placebo Single Dose
n=2 Participants
Intravenous administration of placebo (NSS) in addition to standard of care
|
6 mg/kg Rhu-pGSN Multiple Ascending Dose
n=6 Participants
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care once a day for 3 consecutive days
|
12 mg/kg Rhu-pGSN Multiple Ascending Dose
n=6 Participants
Intravenous administration of recombinant human plasma gelsolin at 12 mg/kg in addition to standard of care once a day for 3 consecutive days
|
24 mg/kg Rhu-pGSN Multiple Ascending Dose
n=6 Participants
Intravenous administration of recombinant human plasma gelsolin at 24 mg/kg in addition to standard of care once a day for 3 consecutive days
|
Placebo Multiple Ascending Dose
n=7 Participants
Intravenous administration of placebo (NSS) in addition to standard of care once a day for 3 consecutive days
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.2 years
n=99 Participants
|
64 years
n=107 Participants
|
69.3 years
n=206 Participants
|
55.3 years
n=7 Participants
|
40 years
n=31 Participants
|
64 years
n=30 Participants
|
58.7 years
n=3 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
17 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
16 Participants
n=3 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
33 Participants
n=3 Participants
|
|
Region of Enrollment
Georgia
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
27 Participants
n=3 Participants
|
|
Region of Enrollment
Australia
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 0-28 daysTreatment emergent adverse events were all adverse events (AEs) that occurred subsequent to enrollment. The seriousness of adverse events was judged by the site investigator.
Outcome measures
| Measure |
6 mg/kg Rhu-pGSN Single Dose
n=6 Participants
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care
|
Placebo Single Dose
n=2 Participants
Intravenous administration of placebo (NSS) in addition to standard of care
|
6 mg/kg Rhu-pGSN Multiple Ascending Dose
n=6 Participants
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care once a day for 3 consecutive days
|
12 mg/kg Rhu-pGSN Multiple Ascending Dose
n=6 Participants
Intravenous administration of recombinant human plasma gelsolin at 12 mg/kg in addition to standard of care once a day for 3 consecutive days
|
24 mg/kg Rhu-pGSN Multiple Ascending Dose
n=6 Participants
Intravenous administration of recombinant human plasma gelsolin at 24 mg/kg in addition to standard of care once a day for 3 consecutive days
|
Placebo Multiple Ascending Dose
n=7 Participants
Intravenous administration of placebo (NSS) in addition to standard of care once a day for 3 consecutive days
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Subjects with at least 1 TEAE
|
4 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Subjects with at least 1 Serious TEAE
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: On Days 0-3, specimens were obtained just prior and immediately post dose and 2, 8,12 and/or 16 , and 24 hours post completion of IV administration. In the single-dose arm, only 1 dose was given and thus no data from later days were obtained.Population: Results from participants given the 6 mg/kg rhu-pGSN dose included 4 subjects in the single-dose arm (samples from 1 subject were lost and 1 subject was withdrawn from the study) and from all 6 patients in the multiple-dose arm given this dose, yielding 10 patients for Dose 1. Only 6 patients were studied on Doses 2 and 3.
Determine AUC 0-t area under the plasma concentration-time curve of rhu-pGSN from 0-24 hours on dosing days (estimated by subtracting pre-injection concentrations from the measured concentrations at each time point). In the single-dose arm, the subject was given only 1 dose so that data from later days were not obtained. In the multiple-dose arms, samples were obtained for each of the 3 doses.
Outcome measures
| Measure |
6 mg/kg Rhu-pGSN Single Dose
n=10 Participants
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care
|
Placebo Single Dose
n=6 Participants
Intravenous administration of placebo (NSS) in addition to standard of care
|
6 mg/kg Rhu-pGSN Multiple Ascending Dose
n=6 Participants
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care once a day for 3 consecutive days
|
12 mg/kg Rhu-pGSN Multiple Ascending Dose
Intravenous administration of recombinant human plasma gelsolin at 12 mg/kg in addition to standard of care once a day for 3 consecutive days
|
24 mg/kg Rhu-pGSN Multiple Ascending Dose
Intravenous administration of recombinant human plasma gelsolin at 24 mg/kg in addition to standard of care once a day for 3 consecutive days
|
Placebo Multiple Ascending Dose
Intravenous administration of placebo (NSS) in addition to standard of care once a day for 3 consecutive days
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK) (Area Under the Rhu-pGSN Concentration - Time Curve)
AUC 0-t, Day 1
|
984.4 µg*h/mL
Standard Deviation 3798.3
|
3450.1 µg*h/mL
Standard Deviation 586.5
|
6911.3 µg*h/mL
Standard Deviation 1914.1
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) (Area Under the Rhu-pGSN Concentration - Time Curve)
AUC 0-t, Day 2
|
674.3 µg*h/mL
Standard Deviation 1062.4
|
2602.8 µg*h/mL
Standard Deviation 755.3
|
1818.4 µg*h/mL
Standard Deviation 4088.5
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) (Area Under the Rhu-pGSN Concentration - Time Curve)
AUC 0-t, Day 3
|
447.4 µg*h/mL
Standard Deviation 626.6
|
3081.8 µg*h/mL
Standard Deviation 1283.5
|
4315.8 µg*h/mL
Standard Deviation 3004.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: On Days 0-3, specimens were obtained just prior and immediately post dose and 2, 8, 12 and/or 16, and 24 hours post completion of IV administration. In the single-dose arm, only 1 dose was given and thus no data from later days were obtained.Population: Results from participants given the 6 mg/kg rhu-pGSN dose included 4 subjects in the single-dose arm (samples from 1 subject were lost and 1 subject was withdrawn from the study) and from all 6 patients in the multiple-dose arm given this dose, yielding results from 10 patients for Dose 1.
Maximum observed plasma concentration (Cmax) of rhu-pGSN in a 24 hours period after intravenous administration (estimated by subtracting pre-injection concentrations from the measured concentrations at each time point). For the 6 mg/kg dose, there were 4 evaluable subjects in the single-dose arm and 6 subjects in the multiple-dose arm at this dose, for a total of 10 evaluable subjects for Dose 1.
Outcome measures
| Measure |
6 mg/kg Rhu-pGSN Single Dose
n=10 Participants
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care
|
Placebo Single Dose
n=6 Participants
Intravenous administration of placebo (NSS) in addition to standard of care
|
6 mg/kg Rhu-pGSN Multiple Ascending Dose
n=6 Participants
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care once a day for 3 consecutive days
|
12 mg/kg Rhu-pGSN Multiple Ascending Dose
Intravenous administration of recombinant human plasma gelsolin at 12 mg/kg in addition to standard of care once a day for 3 consecutive days
|
24 mg/kg Rhu-pGSN Multiple Ascending Dose
Intravenous administration of recombinant human plasma gelsolin at 24 mg/kg in addition to standard of care once a day for 3 consecutive days
|
Placebo Multiple Ascending Dose
Intravenous administration of placebo (NSS) in addition to standard of care once a day for 3 consecutive days
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK) (Maximum Observed Rhu-pGSN Plasma Concentration (Cmax))
Cmax, Day 1
|
226.6 µg/mL
Standard Deviation 393.3
|
291.9 µg/mL
Standard Deviation 38.0
|
533.9 µg/mL
Standard Deviation 139.9
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) (Maximum Observed Rhu-pGSN Plasma Concentration (Cmax))
Cmax, Day 2
|
177.9 µg/mL
Standard Deviation 128.4
|
292.0 µg/mL
Standard Deviation 79.4
|
347.3 µg/mL
Standard Deviation 274.7
|
—
|
—
|
—
|
|
Pharmacokinetics (PK) (Maximum Observed Rhu-pGSN Plasma Concentration (Cmax))
Cmax, Day 3
|
133.9 µg/mL
Standard Deviation 86.0
|
320.6 µg/mL
Standard Deviation 75.4
|
498.8 µg/mL
Standard Deviation 275.3
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 28Population: In this analysis, participants receiving single or multiple doses are reported separately.
Number of participants who developed antibodies against pGSN at study day 28. Patients were first tested against less stringent screening criteria: if screen-positive, a stricter confirmatory test was performed; if screen-negative, no further immunogenicity testing was done.
Outcome measures
| Measure |
6 mg/kg Rhu-pGSN Single Dose
n=2 Participants
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care
|
Placebo Single Dose
n=2 Participants
Intravenous administration of placebo (NSS) in addition to standard of care
|
6 mg/kg Rhu-pGSN Multiple Ascending Dose
n=6 Participants
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care once a day for 3 consecutive days
|
12 mg/kg Rhu-pGSN Multiple Ascending Dose
n=6 Participants
Intravenous administration of recombinant human plasma gelsolin at 12 mg/kg in addition to standard of care once a day for 3 consecutive days
|
24 mg/kg Rhu-pGSN Multiple Ascending Dose
n=6 Participants
Intravenous administration of recombinant human plasma gelsolin at 24 mg/kg in addition to standard of care once a day for 3 consecutive days
|
Placebo Multiple Ascending Dose
n=6 Participants
Intravenous administration of placebo (NSS) in addition to standard of care once a day for 3 consecutive days
|
|---|---|---|---|---|---|---|
|
Number of Participants With Anti-pGSN Antibodies (Immunogenicity) at the End of Study (Day 28)
Screened, positive
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Anti-pGSN Antibodies (Immunogenicity) at the End of Study (Day 28)
Confirmed, positive
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 0-28Population: Results are reported for the combined multiple rhu-pGSN vs. the placebo recipients with available data. One of the placebo recipients in the MAD phase died before dose completion. Since the changes were small across dosing groups, we combined the multi-dose arm in the analysis
CURB-65 (a 5 point score in which 1 point is allocated to the presence of each of the following: Confusion, Urea \>7 mmol/L, Respiratory rate ≥30 breaths min, Blood pressure systolic \<90 mmHg or diastolic ≤60 mmHg, and age ≥65 years); PSI (Pneumonia Severity Index, used to predict risk of morbidity and mortality and is classified in risk classes ranging from I to V from the lowest to highest risk as follows: Class I: PSI 0, class II: PSI 1-70, class III: PSI 71-90, class IV: PSI 91-130, class V: PSI \>130); SOFA (Sequential Organ Failure Assessment, measured based on 6 variables each representing an organ system scored from 0 to 4 each (normal to severe organ dysfunction/failure), and reported as the sum (range 0-24))
Outcome measures
| Measure |
6 mg/kg Rhu-pGSN Single Dose
n=18 Participants
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care
|
Placebo Single Dose
n=7 Participants
Intravenous administration of placebo (NSS) in addition to standard of care
|
6 mg/kg Rhu-pGSN Multiple Ascending Dose
n=6 Participants
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care once a day for 3 consecutive days
|
12 mg/kg Rhu-pGSN Multiple Ascending Dose
n=2 Participants
Intravenous administration of recombinant human plasma gelsolin at 12 mg/kg in addition to standard of care once a day for 3 consecutive days
|
24 mg/kg Rhu-pGSN Multiple Ascending Dose
Intravenous administration of recombinant human plasma gelsolin at 24 mg/kg in addition to standard of care once a day for 3 consecutive days
|
Placebo Multiple Ascending Dose
Intravenous administration of placebo (NSS) in addition to standard of care once a day for 3 consecutive days
|
|---|---|---|---|---|---|---|
|
Baseline and Sequential Severity Scores
CURB-65-Baseline
|
0 unitless
Interval 0.0 to 2.0
|
1 unitless
Interval 0.0 to 2.0
|
1 unitless
Interval 0.0 to 2.0
|
1 unitless
Interval 1.0 to 1.0
|
—
|
—
|
|
Baseline and Sequential Severity Scores
Change in CURB-65 from Baseline to Day 28
|
0 unitless
Interval -1.0 to 1.0
|
0 unitless
Interval -1.0 to 0.0
|
0 unitless
Interval -1.0 to 2.0
|
-0.5 unitless
Interval -1.0 to 0.0
|
—
|
—
|
|
Baseline and Sequential Severity Scores
PSI score-Baseline
|
52 unitless
Interval 38.0 to 91.0
|
78 unitless
Interval 56.0 to 98.0
|
67.5 unitless
Interval 46.0 to 119.0
|
69 unitless
Interval 62.0 to 76.0
|
—
|
—
|
|
Baseline and Sequential Severity Scores
Change in PSI score from Baseline to Day 28
|
0 unitless
Interval -10.0 to 1.0
|
-5 unitless
Interval -10.0 to 0.0
|
0 unitless
Interval 0.0 to 0.0
|
0 unitless
Interval 0.0 to 0.0
|
—
|
—
|
|
Baseline and Sequential Severity Scores
SOFA score-Baseline
|
1 unitless
Interval 0.0 to 3.0
|
1 unitless
Interval 0.0 to 4.0
|
1.5 unitless
Interval 0.0 to 4.0
|
2 unitless
Interval 2.0 to 2.0
|
—
|
—
|
|
Baseline and Sequential Severity Scores
Change in SOFA score from Baseline to Day 28
|
-1 unitless
Interval -3.0 to 0.0
|
-1 unitless
Interval -4.0 to 0.0
|
-1 unitless
Interval -1.0 to 0.0
|
-2 unitless
Interval -2.0 to -2.0
|
—
|
—
|
Adverse Events
6 mg/kg Rhu-pGSN Single Dose
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Placebo Single Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
6 mg/kg Rhu-pGSN Multiple Ascending Dose
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
12 mg/kg Rhu-pGSN Multiple Ascending Dose
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
24 mg/kg Rhu-pGSN Multiple Ascending Dose
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Multiple Ascending Dose
Serious events: 1 serious events
Other events: 4 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
6 mg/kg Rhu-pGSN Single Dose
n=6 participants at risk
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care
|
Placebo Single Dose
n=2 participants at risk
Intravenous administration of placebo (NSS) in addition to standard of care
|
6 mg/kg Rhu-pGSN Multiple Ascending Dose
n=6 participants at risk
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care once a day for 3 consecutive days
|
12 mg/kg Rhu-pGSN Multiple Ascending Dose
n=6 participants at risk
Intravenous administration of recombinant human plasma gelsolin at 12 mg/kg in addition to standard of care once a day for 3 consecutive days
|
24 mg/kg Rhu-pGSN Multiple Ascending Dose
n=6 participants at risk
Intravenous administration of recombinant human plasma gelsolin at 24 mg/kg in addition to standard of care once a day for 3 consecutive days
|
Placebo Multiple Ascending Dose
n=7 participants at risk
Intravenous administration of placebo (NSS) in addition to standard of care once a day for 3 consecutive days
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • Number of events 1 • 0-28 days
|
0.00%
0/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
14.3%
1/7 • Number of events 1 • 0-28 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/6 • 0-28 days
|
0.00%
0/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
14.3%
1/7 • Number of events 1 • 0-28 days
|
Other adverse events
| Measure |
6 mg/kg Rhu-pGSN Single Dose
n=6 participants at risk
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care
|
Placebo Single Dose
n=2 participants at risk
Intravenous administration of placebo (NSS) in addition to standard of care
|
6 mg/kg Rhu-pGSN Multiple Ascending Dose
n=6 participants at risk
Intravenous administration of recombinant human plasma gelsolin at 6 mg/kg in addition to standard of care once a day for 3 consecutive days
|
12 mg/kg Rhu-pGSN Multiple Ascending Dose
n=6 participants at risk
Intravenous administration of recombinant human plasma gelsolin at 12 mg/kg in addition to standard of care once a day for 3 consecutive days
|
24 mg/kg Rhu-pGSN Multiple Ascending Dose
n=6 participants at risk
Intravenous administration of recombinant human plasma gelsolin at 24 mg/kg in addition to standard of care once a day for 3 consecutive days
|
Placebo Multiple Ascending Dose
n=7 participants at risk
Intravenous administration of placebo (NSS) in addition to standard of care once a day for 3 consecutive days
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • 0-28 days
|
0.00%
0/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • 0-28 days
|
0.00%
0/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • 0-28 days
|
0.00%
0/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
16.7%
1/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • 0-28 days
|
0.00%
0/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/6 • 0-28 days
|
50.0%
1/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 0-28 days
|
0.00%
0/2 • 0-28 days
|
16.7%
1/6 • 0-28 days
|
16.7%
1/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • 0-28 days
|
50.0%
1/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
Investigations
Blood creatine phosphokinase increased
|
16.7%
1/6 • 0-28 days
|
0.00%
0/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
Investigations
Liver function test abnormal
|
0.00%
0/6 • 0-28 days
|
50.0%
1/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
Investigations
Blood pressure increased
|
0.00%
0/6 • 0-28 days
|
0.00%
0/2 • 0-28 days
|
33.3%
2/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/6 • 0-28 days
|
50.0%
1/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • 0-28 days
|
0.00%
0/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
16.7%
1/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
Nervous system disorders
Headaches
|
16.7%
1/6 • 0-28 days
|
0.00%
0/2 • 0-28 days
|
16.7%
1/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
14.3%
1/7 • 0-28 days
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/6 • 0-28 days
|
50.0%
1/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • 0-28 days
|
0.00%
0/2 • 0-28 days
|
16.7%
1/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
0.00%
0/6 • 0-28 days
|
50.0%
1/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • 0-28 days
|
50.0%
1/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • 0-28 days
|
50.0%
1/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • 0-28 days
|
0.00%
0/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
16.7%
1/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • 0-28 days
|
0.00%
0/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
16.7%
1/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
General disorders
Fatigue
|
0.00%
0/6 • 0-28 days
|
0.00%
0/2 • 0-28 days
|
16.7%
1/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
14.3%
1/7 • 0-28 days
|
|
General disorders
Pyrexia
|
0.00%
0/6 • 0-28 days
|
0.00%
0/2 • 0-28 days
|
16.7%
1/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
14.3%
1/7 • 0-28 days
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • 0-28 days
|
0.00%
0/2 • 0-28 days
|
16.7%
1/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/7 • 0-28 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • 0-28 days
|
0.00%
0/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
16.7%
1/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
14.3%
1/7 • 0-28 days
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • 0-28 days
|
50.0%
1/2 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
0.00%
0/6 • 0-28 days
|
14.3%
1/7 • 0-28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place