Trial Outcomes & Findings for Safety Study of Tezepelumab (AMG 157) in Healthy Adults (NCT NCT00972179)
NCT ID: NCT00972179
Last Updated: 2022-09-21
Results Overview
Adverse events (AEs) include any untoward medical occurrence in a trial participant administered a study drug and does not necessarily have a causal relationship with this treatment. AEs include worsening of a pre-existing medical condition and laboratory value changes requiring therapy or adjustment in prior therapy. AEs were assessed for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening AE and Grade 5 = death due to AE. Relationship to study treatment was determined by the investigator. A serious adverse event (SAE) is defined as an AE that met 1 or more of below criteria: * was fatal; * was life threatening; * required in-patient hospitalization or prolongation of existing hospitalization; * resulted in persistent or significant disability/incapacity; * was a congenital anomaly/birth defect; * other significant medical hazard.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
49 participants
Primary outcome timeframe
From first dose of study drug up to day 169
Results posted on
2022-09-21
Participant Flow
This study was conducted at a single center in the United States.
Participants were enrolled into 1 of 6 cohorts. In the first 5 cohorts escalating subcutaneous doses of tezepelumab were compared with placebo and in cohort 6 a regimen of intravenous tezepelumab was compared with placebo. Within each cohort, healthy participants were randomized at a 6:2 ratio to receive either tezepelumab or placebo.
Participant milestones
| Measure |
Tezepelumab 35 mg Q28D
Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for 3 doses.
|
Tezepelumab 105 mg Q28D
Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q28D
Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q14D
Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
|
Tezepelumab 210 mg Q7D
Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
|
Tezepelumab 700 mg Q28D IV
Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
|
Placebo
Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
7
|
6
|
12
|
|
Overall Study
COMPLETED
|
5
|
3
|
5
|
5
|
5
|
3
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
1
|
1
|
2
|
3
|
4
|
Reasons for withdrawal
| Measure |
Tezepelumab 35 mg Q28D
Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for 3 doses.
|
Tezepelumab 105 mg Q28D
Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q28D
Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q14D
Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
|
Tezepelumab 210 mg Q7D
Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
|
Tezepelumab 700 mg Q28D IV
Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
|
Placebo
Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Noncompliance
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
0
|
1
|
0
|
0
|
2
|
|
Overall Study
Administrative Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
3
|
1
|
Baseline Characteristics
Safety Study of Tezepelumab (AMG 157) in Healthy Adults
Baseline characteristics by cohort
| Measure |
Tezepelumab 35 mg Q28D
n=6 Participants
Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for 3 doses.
|
Tezepelumab 105 mg Q28D
n=6 Participants
Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q28D
n=6 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q14D
n=6 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
|
Tezepelumab 210 mg Q7D
n=7 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
|
Tezepelumab 700 mg Q28D IV
n=6 Participants
Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
|
Placebo
n=12 Participants
Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.8 year
STANDARD_DEVIATION 9.3 • n=99 Participants
|
34.8 year
STANDARD_DEVIATION 5.8 • n=107 Participants
|
32.3 year
STANDARD_DEVIATION 5.3 • n=206 Participants
|
31.5 year
STANDARD_DEVIATION 5.6 • n=7 Participants
|
36.1 year
STANDARD_DEVIATION 7.7 • n=31 Participants
|
27.7 year
STANDARD_DEVIATION 4.1 • n=30 Participants
|
34.1 year
STANDARD_DEVIATION 5.2 • n=3 Participants
|
32.6 year
STANDARD_DEVIATION 6.4 • n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
7 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
42 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
17 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
7 Participants
n=3 Participants
|
29 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug up to day 169Population: All participants who received at least 1 dose of study drug
Adverse events (AEs) include any untoward medical occurrence in a trial participant administered a study drug and does not necessarily have a causal relationship with this treatment. AEs include worsening of a pre-existing medical condition and laboratory value changes requiring therapy or adjustment in prior therapy. AEs were assessed for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening AE and Grade 5 = death due to AE. Relationship to study treatment was determined by the investigator. A serious adverse event (SAE) is defined as an AE that met 1 or more of below criteria: * was fatal; * was life threatening; * required in-patient hospitalization or prolongation of existing hospitalization; * resulted in persistent or significant disability/incapacity; * was a congenital anomaly/birth defect; * other significant medical hazard.
Outcome measures
| Measure |
Tezepelumab 35 mg Q28D
n=6 Participants
Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for three doses.
|
Tezepelumab 105 mg Q28D
n=6 Participants
Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q28D
n=6 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q14D
n=6 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
|
Tezepelumab 210 mg Q7D
n=7 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
|
Tezepelumab 700 mg Q28D IV
n=6 Participants
Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
|
Placebo
n=12 Participants
Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events
Any adverse event
|
4 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
10 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Serious adverse events
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
AE Leading to discontinuation of study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
AE Leading to discontinuation from study
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Grade 3 adverse events
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Grade 4 adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Fatal (grade 5) adverse events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events
Any treatment-related adverse event
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: For Q28D groups: Days 28, 56, 85, 113, and 169; For Q14D and Q7D groups: Days 29, 57, 85, 113, 141, and 169Population: All participants who received at least 1 dose of study drug
All study samples (tezepelumab and placebo) were tested using an electrochemiluminescence (ECL) based immunoassay to detect and confirm the presence of antibodies capable of binding to tezepelumab. Samples identified as positive in the immunoassay were tested in a receptor-binding ECL-based assay to detect neutralizing or inhibitory effects toward tezepelumab. The number of participants with positive anti-tezepelumab binding antibodies / neutralizing antibodies at any time post-baseline with a negative or no result at baseline is reported.
Outcome measures
| Measure |
Tezepelumab 35 mg Q28D
n=6 Participants
Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for three doses.
|
Tezepelumab 105 mg Q28D
n=6 Participants
Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q28D
n=6 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q14D
n=6 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
|
Tezepelumab 210 mg Q7D
n=7 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
|
Tezepelumab 700 mg Q28D IV
n=6 Participants
Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
|
Placebo
n=12 Participants
Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Who Developed Anti-tezepelumab Antibodies After Initiation of Treatment
Anti-tezepelumab binding antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Developed Anti-tezepelumab Antibodies After Initiation of Treatment
Anti-tezepelumab neutralizing antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: First dose: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D & Q28D only) and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) predose, EOI (IV cohort), 4 hours, 3, 7, 14, 28 days postdosePopulation: Participants who received tezepelumab and had a sufficient number of serum concentration measurements for computing the PK parameter after first dose and after last dose.
The pharmacokinetic (PK) parameter Tmax was estimated based on the serum concentrations of tezepelumab using noncompartmental methods. The concentration of tezepelumab in human serum was measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification of the assay was 10 ng/ml.
Outcome measures
| Measure |
Tezepelumab 35 mg Q28D
n=6 Participants
Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for three doses.
|
Tezepelumab 105 mg Q28D
n=6 Participants
Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q28D
n=6 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q14D
n=6 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
|
Tezepelumab 210 mg Q7D
n=7 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
|
Tezepelumab 700 mg Q28D IV
n=6 Participants
Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
|
Placebo
Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.
|
|---|---|---|---|---|---|---|---|
|
Time of Maximum Observed Concentration (Tmax) of Tezepelumab
First dose
|
160 hours
Interval 69.7 to 167.0
|
71.5 hours
Interval 70.4 to 167.0
|
118 hours
Interval 68.7 to 166.0
|
70.7 hours
Interval 69.9 to 168.0
|
164 hours
Interval 66.9 to 165.0
|
4.00 hours
Interval 1.13 to 4.17
|
—
|
|
Time of Maximum Observed Concentration (Tmax) of Tezepelumab
Last dose
|
166 hours
Interval 68.6 to 176.0
|
71.8 hours
Interval 70.7 to 167.0
|
167 hours
Interval 69.3 to 168.0
|
66.5 hours
Interval 65.1 to 162.0
|
74.4 hours
Interval 65.9 to 164.0
|
3.97 hours
Interval 1.17 to 4.03
|
—
|
SECONDARY outcome
Timeframe: First dose: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D & Q28D only) and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) predose, EOI (IV cohort), 4 hours, 3, 7, 14, 28 days postdosePopulation: Participants who received tezepelumab and had a sufficient number of serum concentration measurements for computing the PK parameter after first dose and after last dose.
The PK parameter Cmax was estimated based on the serum concentrations of tezepelumab using noncompartmental methods. The concentration of tezepelumab in human serum was measured using a validated ELISA. The lower limit of quantification of the assay was 10 ng/ml.
Outcome measures
| Measure |
Tezepelumab 35 mg Q28D
n=6 Participants
Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for three doses.
|
Tezepelumab 105 mg Q28D
n=6 Participants
Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q28D
n=6 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q14D
n=6 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
|
Tezepelumab 210 mg Q7D
n=7 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
|
Tezepelumab 700 mg Q28D IV
n=6 Participants
Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
|
Placebo
Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.
|
|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Tezepelumab
First dose
|
3.70 µg/mL
Standard Deviation 1.16
|
10.7 µg/mL
Standard Deviation 3.13
|
23.6 µg/mL
Standard Deviation 9.50
|
23.8 µg/mL
Standard Deviation 5.40
|
18.0 µg/mL
Standard Deviation 4.58
|
294 µg/mL
Standard Deviation 48.2
|
—
|
|
Maximum Observed Concentration (Cmax) of Tezepelumab
Last dose
|
6.29 µg/mL
Standard Deviation 2.02
|
16.6 µg/mL
Standard Deviation 2.02
|
37.4 µg/mL
Standard Deviation 17.5
|
63.8 µg/mL
Standard Deviation 13.5
|
117 µg/mL
Standard Deviation 45.6
|
370 µg/mL
Standard Deviation 74.9
|
—
|
SECONDARY outcome
Timeframe: First dose: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D & Q28D only) and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) predose, EOI (IV cohort), 4 hours, 3, 7, 14, 28 days postdosePopulation: Participants who received tezepelumab and had a sufficient number of serum concentration measurements for computing the PK parameter after first dose and after last dose.
The PK parameter AUCtau was estimated based on the serum concentrations of tezepelumab using noncompartmental methods. The dosing interval (tau) was 28 days, 14 days or 7 days depending on the treatment arm. The concentration of tezepelumab in human serum was measured using a validated ELISA. The lower limit of quantification of the assay was 10 ng/ml.
Outcome measures
| Measure |
Tezepelumab 35 mg Q28D
n=6 Participants
Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for three doses.
|
Tezepelumab 105 mg Q28D
n=5 Participants
Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q28D
n=6 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q14D
n=6 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
|
Tezepelumab 210 mg Q7D
n=7 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
|
Tezepelumab 700 mg Q28D IV
n=6 Participants
Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
|
Placebo
Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) for Tezepelumab
Last dose
|
136 days*µg/mL
Standard Deviation 35.9
|
333 days*µg/mL
Standard Deviation 28.8
|
799 days*µg/mL
Standard Deviation 338
|
787 days*µg/mL
Standard Deviation 180
|
732 days*µg/mL
Standard Deviation 224
|
4050 days*µg/mL
Standard Deviation 1270
|
—
|
|
Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) for Tezepelumab
First dose
|
78.9 days*µg/mL
Standard Deviation 23.4
|
237 days*µg/mL
Standard Deviation 50.5
|
481 days*µg/mL
Standard Deviation 171
|
263 days*µg/mL
Standard Deviation 49.2
|
84.3 days*µg/mL
Standard Deviation 34.9
|
2980 days*µg/mL
Standard Deviation 395
|
—
|
SECONDARY outcome
Timeframe: First dose: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D & Q28D only) and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) predose, EOI (IV cohort), 4 hours, 3, 7, 14, 28 days postdosePopulation: Participants who received tezepelumab and had a sufficient number of serum concentration measurements for computing the PK parameter after first dose and after last dose.
Accumulation ratio (AR) based on AUCtau was calculated as AUCtau after last dose / AUCtau after first dose, except for the Q7D cohort where AR was calculated as AUCtau after last dose / area under the concentration-time curve from time 0 to time of last measurable concentration (AUC0-t) after first dose.
Outcome measures
| Measure |
Tezepelumab 35 mg Q28D
n=5 Participants
Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for three doses.
|
Tezepelumab 105 mg Q28D
n=3 Participants
Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q28D
n=5 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q14D
n=6 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
|
Tezepelumab 210 mg Q7D
n=5 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
|
Tezepelumab 700 mg Q28D IV
n=5 Participants
Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
|
Placebo
Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.
|
|---|---|---|---|---|---|---|---|
|
Accumulation Ratio Based on AUCtau
|
1.82 ratio
Standard Deviation 0.262
|
1.64 ratio
Standard Deviation 0.0883
|
1.59 ratio
Standard Deviation 0.242
|
2.89 ratio
Standard Deviation 0.892
|
8.23 ratio
Standard Deviation 1.93
|
1.34 ratio
Standard Deviation 0.314
|
—
|
SECONDARY outcome
Timeframe: First dose: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D & Q28D only) and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) predose, EOI (IV cohort), 4 hours, 3, 7, 14, 28 days postdosePopulation: Participants who received tezepelumab and had a sufficient number of serum concentration measurements for computing the PK parameter after first dose and after last dose.
Accumulation ratio based on Cmax calculated as Cmax after last dose / Cmax after first dose
Outcome measures
| Measure |
Tezepelumab 35 mg Q28D
n=5 Participants
Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for three doses.
|
Tezepelumab 105 mg Q28D
n=3 Participants
Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q28D
n=5 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q14D
n=6 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
|
Tezepelumab 210 mg Q7D
n=5 Participants
Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
|
Tezepelumab 700 mg Q28D IV
n=5 Participants
Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
|
Placebo
Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.
|
|---|---|---|---|---|---|---|---|
|
Accumulation Ratio Based on Cmax
|
1.79 ratio
Standard Deviation 0.392
|
1.66 ratio
Standard Deviation 0.0901
|
1.59 ratio
Standard Deviation 0.288
|
2.84 ratio
Standard Deviation 0.965
|
6.74 ratio
Standard Deviation 1.69
|
1.30 ratio
Standard Deviation 0.176
|
—
|
Adverse Events
Tezepelumab 35 mg Q28D
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Tezepelumab 105 mg Q28D
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Tezepelumab 210 mg Q28D
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Tezepelumab 210 mg Q14D
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Tezepelumab 210 mg Q7D
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Tezepelumab 700 mg Q28D IV
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Tezepelumab Total
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tezepelumab 35 mg Q28D
n=6 participants at risk
Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for 3 doses.
|
Tezepelumab 105 mg Q28D
n=6 participants at risk
Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q28D
n=6 participants at risk
Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q14D
n=6 participants at risk
Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
|
Tezepelumab 210 mg Q7D
n=7 participants at risk
Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
|
Tezepelumab 700 mg Q28D IV
n=6 participants at risk
Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
|
Tezepelumab Total
n=37 participants at risk
All participants who received tezepelumab.
|
Placebo
n=12 participants at risk
Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Hepatitis C
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
Other adverse events
| Measure |
Tezepelumab 35 mg Q28D
n=6 participants at risk
Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for 3 doses.
|
Tezepelumab 105 mg Q28D
n=6 participants at risk
Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q28D
n=6 participants at risk
Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
|
Tezepelumab 210 mg Q14D
n=6 participants at risk
Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
|
Tezepelumab 210 mg Q7D
n=7 participants at risk
Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
|
Tezepelumab 700 mg Q28D IV
n=6 participants at risk
Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
|
Tezepelumab Total
n=37 participants at risk
All participants who received tezepelumab.
|
Placebo
n=12 participants at risk
Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.
|
|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Eye irritation
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/37 • From first dose of study drug up to day 169
|
8.3%
1/12 • From first dose of study drug up to day 169
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
14.3%
1/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
5.4%
2/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
General disorders
Application site dermatitis
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
5.4%
2/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
General disorders
Fatigue
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
14.3%
1/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
5.4%
2/37 • From first dose of study drug up to day 169
|
8.3%
1/12 • From first dose of study drug up to day 169
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/37 • From first dose of study drug up to day 169
|
8.3%
1/12 • From first dose of study drug up to day 169
|
|
General disorders
Injection site haematoma
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
28.6%
2/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
5.4%
2/37 • From first dose of study drug up to day 169
|
8.3%
1/12 • From first dose of study drug up to day 169
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
14.3%
1/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
General disorders
Injection site irritation
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
General disorders
Injection site pain
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
28.6%
2/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
8.1%
3/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
General disorders
Injection site pruritus
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/37 • From first dose of study drug up to day 169
|
8.3%
1/12 • From first dose of study drug up to day 169
|
|
General disorders
Injection site swelling
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
14.3%
1/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
5.4%
2/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
General disorders
Injection site urticaria
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/37 • From first dose of study drug up to day 169
|
8.3%
1/12 • From first dose of study drug up to day 169
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/37 • From first dose of study drug up to day 169
|
8.3%
1/12 • From first dose of study drug up to day 169
|
|
Infections and infestations
Hepatitis C
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Infections and infestations
Influenza
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
5.4%
2/37 • From first dose of study drug up to day 169
|
16.7%
2/12 • From first dose of study drug up to day 169
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
14.3%
1/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
8.1%
3/37 • From first dose of study drug up to day 169
|
16.7%
2/12 • From first dose of study drug up to day 169
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/37 • From first dose of study drug up to day 169
|
8.3%
1/12 • From first dose of study drug up to day 169
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Injury, poisoning and procedural complications
Skin laceration
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
14.3%
1/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/37 • From first dose of study drug up to day 169
|
8.3%
1/12 • From first dose of study drug up to day 169
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
28.6%
2/7 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
8.1%
3/37 • From first dose of study drug up to day 169
|
16.7%
2/12 • From first dose of study drug up to day 169
|
|
Investigations
Body temperature increased
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
8.3%
1/12 • From first dose of study drug up to day 169
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
14.3%
1/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
5.4%
2/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/37 • From first dose of study drug up to day 169
|
8.3%
1/12 • From first dose of study drug up to day 169
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/37 • From first dose of study drug up to day 169
|
8.3%
1/12 • From first dose of study drug up to day 169
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
14.3%
1/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
5.4%
2/37 • From first dose of study drug up to day 169
|
8.3%
1/12 • From first dose of study drug up to day 169
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
16.7%
2/12 • From first dose of study drug up to day 169
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From first dose of study drug up to day 169
|
33.3%
2/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
33.3%
2/6 • From first dose of study drug up to day 169
|
42.9%
3/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
21.6%
8/37 • From first dose of study drug up to day 169
|
16.7%
2/12 • From first dose of study drug up to day 169
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/37 • From first dose of study drug up to day 169
|
8.3%
1/12 • From first dose of study drug up to day 169
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
2.7%
1/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
5.4%
2/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/37 • From first dose of study drug up to day 169
|
8.3%
1/12 • From first dose of study drug up to day 169
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
16.7%
1/6 • From first dose of study drug up to day 169
|
5.4%
2/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/37 • From first dose of study drug up to day 169
|
8.3%
1/12 • From first dose of study drug up to day 169
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
2/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
14.3%
1/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
8.1%
3/37 • From first dose of study drug up to day 169
|
0.00%
0/12 • From first dose of study drug up to day 169
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/7 • From first dose of study drug up to day 169
|
0.00%
0/6 • From first dose of study drug up to day 169
|
0.00%
0/37 • From first dose of study drug up to day 169
|
8.3%
1/12 • From first dose of study drug up to day 169
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER