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CompletedNCT00972179Updated Sep 21, 2022Results posted

Safety Study of Tezepelumab (AMG 157) in Healthy Adults

A Phase 1 interventional study of Placebo and Tezepelumab in Healthy Volunteers, sponsored by Amgen. Completed. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-21.

Sponsored by Amgen · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The primary objective is to evaluate the safety, tolerability, and immunogenicity of multiple-dose administration of tezepelumab in healthy adults.

Read the detailed description

This study will follow a randomized, multiple-dose, double-blind, placebo-controlled, sequential dose-escalation study design. The study will consist of five subcutaneous (SC) cohorts and one intravenous (IV) cohort. Each dose cohort is planned to enroll 8 participants, randomized such that 6 participants will receive tezepelumab and 2 will receive placebo (3:1 ratio).

02

Conditions studied

  • Healthy Volunteers

Keywords

  • healthy volunteers
03

In context

Lead sponsor

Amgen is the lead sponsor of 1,044 studies on the registry; 51 are open to participants now.

Of its 246 completed or terminated interventional studies of FDA-regulated products, 164 (67%) have results posted.

Browse Amgen studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects must sign an Institutional Review Board (IRB) approved informed consent form before any study-specific procedures;
  • Healthy subject, aged between 18 and 45 years, inclusive;
  • Female subject must be of non-reproductive potential (ie, postmenopausal by history - no menses for ≥ 1 year and by follicle-stimulating hormone (FSH) [using local reference ranges]; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy);
  • Male subjects with female partner of childbearing potential who agrees to inform their female partner of their participation in this clinical study and use highly effective methods of birth control during the study. (Highly effective methods of birth control may include abstinence, vasectomy, or a condom with spermicide in combination with either hormonal birth control, intra-uterine device, or barrier methods used by the woman);
  • Male subject who agrees to use birth control for five months after last dose of study medication, male subject who agrees not to donate sperm during the study and for five months after last dose of study medication;
  • Healthy subject with a body mass index (BMI) between 18 and 32 kg/m\^2, inclusive at screening;
  • Subject must have normal or clinically acceptable physical examination and electrocardiogram (ECG) results prior to Day 1 based on the opinion of the investigator;
  • Subject must have normal or clinically acceptable clinical laboratory tests at screening as determined by Amgen and the investigator;
  • Subject must have adequate renal function (defined as creatinine clearance > 80 mL/min using the Cockcroft Gault equation).

Exclusion criteria

Exclusion Criteria:

  • Subject who has history or evidence of a clinically significant disorder, condition or disease (including but not limited to cardiopulmonary, oncologic, immunologic, autoimmune, collagen vascular, renal, metabolic, hematologic or psychiatric), that, in the opinion of the Investigator in consultation with the Amgen physician, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
  • Subject who has evidence of any active or suspected bacterial, viral, fungal or parasitic infections within the past 30 days prior to randomization (eg, common cold, viral syndrome, flu-like symptoms). Subject who, in the opinion of the investigator, has a high risk of parasitic disease is also excluded;
  • Subject who has known positive tuberculin skin test (if not treated with appropriate chemoprophylaxis) or recent (within six months from randomization) exposure to an individual with active tuberculosis;
  • Subject who has history of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers within five years before randomization of the study;
  • Subject who has known type I/II diabetes;
  • Subject who uses nonprescription drugs within 14 days prior to randomization and for the entire duration of the study. All herbal supplements, vitamins, and nutritional supplements taken within the last 30 days prior to dosing on Day 1 (and continued use, if appropriate), must be reviewed and approved by the PI and Amgen Medical Monitor;
  • Subject who has used any systemic cytotoxic or systemic immunosuppressive medications (other than corticosteroids) within 6 months prior to randomization and for the entire duration of the study or has used any corticosteroid, topical cytotoxic or topical immunosuppressive medications within 30 days or five half-lives (whichever is longer) prior to randomization and for the entire duration of the study;
  • Subject who has previously received any other therapeutic monoclonal antibody;
  • Subject who has previously received any investigational drug (or is currently using an investigational device) within 30 days or five half-lives (whichever is longer) prior to randomization;
  • Subject who has tested positive for drugs and/or alcohol use at screening or before randomization, subject who has consumed alcohol within 48 hours prior to any study visit including screening, and subject with alcohol intake of > 2 drinks/day on average during the study (one drink being equivalent to 12 ounces of regular beer, 8 to 9 ounces of malt liquor, 5 ounces of wine or 1.5 ounces of 80 proof distilled spirits);
  • Female subject who is pregnant or lactating; female subject who is of child-bearing potential;
  • Subject who has donated blood (including blood products) or experienced loss of blood ≥ 500 mL within two months of study screening;
  • Subject who is positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen, or hepatitis C antibodies;
  • Subject who has regularly used nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) during six months before randomization and during the study;
  • Subject who has any other condition that might reduce the chance of obtaining data (eg, known poor compliance) required by the protocol or that might compromise the ability to give truly informed consent.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    Tezepelumab

    Tezepelumab will be administered subcutaneously (SC) at doses from 35 mg once every 28 days (Q28D) (cohort 1) up to 210 mg once every 7 days (Q7D) (cohort 5) and an intravenous (IV) dose cohort of 700 mg Q28D (cohort 6).

    Drug: Tezepelumab

  • Placebo comparator
    Placebo

    Two participants in each cohort (cohorts 1 to 6) will receive matching placebo administered subcutaneously (cohorts 1-5) or intravenously (cohort 6), matching the treatment regiment of tezepelumab.

    Drug: Placebo

Interventions

  • DrugPlacebo

    Administered by subcutaneous or intravenous injection.

  • DrugTezepelumab

    Administered by subcutaneous or intravenous injection

    Also known as: AMG 157, Tezspire

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events

    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.

    Time frame: From first dose of study drug up to day 169

  2. Number of Participants Who Developed Anti-tezepelumab Antibodies After Initiation of Treatment

    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.

    Time frame: For Q28D groups: Days 28, 56, 85, 113, and 169; For Q14D and Q7D groups: Days 29, 57, 85, 113, 141, and 169

Secondary outcomes

  1. Time of Maximum Observed Concentration (Tmax) of Tezepelumab

    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.

    Time frame: 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 postdose

  2. Maximum Observed Concentration (Cmax) of Tezepelumab

    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.

    Time frame: 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 postdose

  3. Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) for Tezepelumab

    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.

    Time frame: 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 postdose

  4. Accumulation Ratio Based on AUCtau

    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.

    Time frame: 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 postdose

  5. Accumulation Ratio Based on Cmax

    Accumulation ratio based on Cmax calculated as Cmax after last dose / Cmax after first dose

    Time frame: 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 postdose

07

Results

Posted May 23, 2022

Participant flow

This study was conducted at a single center in the United States.

Participant flow — Overall Study
MilestoneTezepelumab 35 mg Q28DTezepelumab 105 mg Q28DTezepelumab 210 mg Q28DTezepelumab 210 mg Q14DTezepelumab 210 mg Q7DTezepelumab 700 mg Q28D IVPlacebo
Started66667612
Completed5355538
Not completed1311234
Withdrew: Noncompliance1000101
Withdrew: Withdrawal by subject0301002
Withdrew: Administrative decision0000100
Withdrew: Lost to follow-up0010031

Outcome measures

PrimaryNumber of Participants With Treatment-emergent Adverse Events

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.

Time frame:
From first dose of study drug up to day 169
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events
ParticipantsTezepelumab 35 mg Q28DTezepelumab 105 mg Q28DTezepelumab 210 mg Q28DTezepelumab 210 mg Q14DTezepelumab 210 mg Q7DTezepelumab 700 mg Q28D IVPlacebo
Any adverse event44265310
Serious adverse events1000000
AE Leading to discontinuation of study drug0000000
AE Leading to discontinuation from study0000000
Grade 3 adverse events1001112
Grade 4 adverse events0000100
Fatal (grade 5) adverse events0000000
Any treatment-related adverse event2011302
SecondaryTime of Maximum Observed Concentration (Tmax) of Tezepelumab

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.

Time frame:
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 postdose
Reported as:
Median · hours
Time of Maximum Observed Concentration (Tmax) of Tezepelumab
hoursTezepelumab 35 mg Q28DTezepelumab 105 mg Q28DTezepelumab 210 mg Q28DTezepelumab 210 mg Q14DTezepelumab 210 mg Q7DTezepelumab 700 mg Q28D IV
First dose160 (69.7 to 167)71.5 (70.4 to 167)118 (68.7 to 166)70.7 (69.9 to 168)164 (66.9 to 165)4.00 (1.13 to 4.17)
Last dose166 (68.6 to 176)71.8 (70.7 to 167)167 (69.3 to 168)66.5 (65.1 to 162)74.4 (65.9 to 164)3.97 (1.17 to 4.03)
PrimaryNumber of Participants Who Developed Anti-tezepelumab Antibodies After Initiation of Treatment

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.

Time frame:
For Q28D groups: Days 28, 56, 85, 113, and 169; For Q14D and Q7D groups: Days 29, 57, 85, 113, 141, and 169
Reported as:
Count of participants · Participants
Number of Participants Who Developed Anti-tezepelumab Antibodies After Initiation of Treatment
ParticipantsTezepelumab 35 mg Q28DTezepelumab 105 mg Q28DTezepelumab 210 mg Q28DTezepelumab 210 mg Q14DTezepelumab 210 mg Q7DTezepelumab 700 mg Q28D IVPlacebo
Anti-tezepelumab binding antibodies0000000
Anti-tezepelumab neutralizing antibodies0000000
SecondaryMaximum Observed Concentration (Cmax) of Tezepelumab

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.

Time frame:
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 postdose
Reported as:
Mean · µg/mL
Maximum Observed Concentration (Cmax) of Tezepelumab
µg/mLTezepelumab 35 mg Q28DTezepelumab 105 mg Q28DTezepelumab 210 mg Q28DTezepelumab 210 mg Q14DTezepelumab 210 mg Q7DTezepelumab 700 mg Q28D IV
First dose3.70 ± 1.1610.7 ± 3.1323.6 ± 9.5023.8 ± 5.4018.0 ± 4.58294 ± 48.2
Last dose6.29 ± 2.0216.6 ± 2.0237.4 ± 17.563.8 ± 13.5117 ± 45.6370 ± 74.9
SecondaryArea Under the Concentration-time Curve Over the Dosing Interval (AUCtau) for Tezepelumab

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.

Time frame:
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 postdose
Reported as:
Mean · days*µg/mL
Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) for Tezepelumab
days*µg/mLTezepelumab 35 mg Q28DTezepelumab 105 mg Q28DTezepelumab 210 mg Q28DTezepelumab 210 mg Q14DTezepelumab 210 mg Q7DTezepelumab 700 mg Q28D IV
First dose78.9 ± 23.4237 ± 50.5481 ± 171263 ± 49.284.3 ± 34.92980 ± 395
Last dose136 ± 35.9333 ± 28.8799 ± 338787 ± 180732 ± 2244050 ± 1270
SecondaryAccumulation Ratio Based on AUCtau

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.

Time frame:
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 postdose
Reported as:
Mean · ratio
Accumulation Ratio Based on AUCtau
ratioTezepelumab 35 mg Q28DTezepelumab 105 mg Q28DTezepelumab 210 mg Q28DTezepelumab 210 mg Q14DTezepelumab 210 mg Q7DTezepelumab 700 mg Q28D IV
Accumulation Ratio Based on AUCtau1.82 ± 0.2621.64 ± 0.08831.59 ± 0.2422.89 ± 0.8928.23 ± 1.931.34 ± 0.314
SecondaryAccumulation Ratio Based on Cmax

Accumulation ratio based on Cmax calculated as Cmax after last dose / Cmax after first dose

Time frame:
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 postdose
Reported as:
Mean · ratio
Accumulation Ratio Based on Cmax
ratioTezepelumab 35 mg Q28DTezepelumab 105 mg Q28DTezepelumab 210 mg Q28DTezepelumab 210 mg Q14DTezepelumab 210 mg Q7DTezepelumab 700 mg Q28D IV
Accumulation Ratio Based on Cmax1.79 ± 0.3921.66 ± 0.09011.59 ± 0.2882.84 ± 0.9656.74 ± 1.691.30 ± 0.176

Adverse events

Collected over From first dose of study drug up to day 169. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Tezepelumab 35 mg Q28D—1/6 (16.7%)4/6 (66.7%)
Tezepelumab 105 mg Q28D—0/6 (0%)4/6 (66.7%)
Tezepelumab 210 mg Q28D—0/6 (0%)2/6 (33.3%)
Tezepelumab 210 mg Q14D—0/6 (0%)6/6 (100%)
Tezepelumab 210 mg Q7D—0/7 (0%)5/7 (71.4%)
Tezepelumab 700 mg Q28D IV—0/6 (0%)3/6 (50%)
Tezepelumab Total—1/37 (2.7%)24/37 (64.9%)
Placebo—0/12 (0%)10/12 (83.3%)
Most frequent serious events
Most frequent serious events
EventTezepelumab 35 mg Q28DTezepelumab 105 mg Q28DTezepelumab 210 mg Q28DTezepelumab 210 mg Q14DTezepelumab 210 mg Q7DTezepelumab 700 mg Q28D IVTezepelumab TotalPlacebo
Hepatitis CInfections and infestations1/60/60/60/60/70/61/370/12
Most frequent other events
Showing 10 of 51
Most frequent other events
EventTezepelumab 35 mg Q28DTezepelumab 105 mg Q28DTezepelumab 210 mg Q28DTezepelumab 210 mg Q14DTezepelumab 210 mg Q7DTezepelumab 700 mg Q28D IVTezepelumab TotalPlacebo
HeadacheNervous system disorders0/62/61/62/63/70/68/372/12
PruritusSkin and subcutaneous tissue disorders2/60/60/60/61/70/63/370/12
Injection site haematomaGeneral disorders0/60/60/60/62/70/62/371/12
Injection site painGeneral disorders0/60/61/60/62/70/63/370/12
Blood creatine phosphokinase increasedInvestigations0/60/60/60/62/71/63/372/12
Eye irritationEye disorders0/60/60/61/60/70/61/370/12
Abdominal painGastrointestinal disorders0/60/61/60/60/70/61/370/12
NauseaGastrointestinal disorders0/60/60/61/61/70/62/370/12
Application site dermatitisGeneral disorders0/61/60/61/60/70/62/370/12
FatigueGeneral disorders0/60/60/61/61/70/62/371/12

Baseline characteristics

Participants who received at least 1 dose of study drug (Safety population).

Age, Continuous
Age, Continuous(year)Tezepelumab 35 mg Q28DTezepelumab 105 mg Q28DTezepelumab 210 mg Q28DTezepelumab 210 mg Q14DTezepelumab 210 mg Q7DTezepelumab 700 mg Q28D IVPlaceboTotal
Mean29.8 ± 9.334.8 ± 5.832.3 ± 5.331.5 ± 5.636.1 ± 7.727.7 ± 4.134.1 ± 5.232.6 ± 6.4
Sex: Female, Male
Sex: Female, Male(Participants)Tezepelumab 35 mg Q28DTezepelumab 105 mg Q28DTezepelumab 210 mg Q28DTezepelumab 210 mg Q14DTezepelumab 210 mg Q7DTezepelumab 700 mg Q28D IVPlaceboTotal
Female00041027
Male6662661042
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Tezepelumab 35 mg Q28DTezepelumab 105 mg Q28DTezepelumab 210 mg Q28DTezepelumab 210 mg Q14DTezepelumab 210 mg Q7DTezepelumab 700 mg Q28D IVPlaceboTotal
White302143417
Black or African American00000213
Hispanic or Latino364531729
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Parnes JR, Sullivan JT, Chen L, Dias C. Pharmacokinetics, Safety, and Tolerability of Tezepelumab (AMG 157) in Healthy and Atopic Dermatitis Adult Subjects. Clin Pharmacol Ther. 2019 Aug;106(2):441-449. doi: 10.1002/cpt.1401. Epub 2019 Mar 23. PubMed 30779339 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00972179
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Sep 4, 2009
Start date
Sep 15, 2009
Primary completion
Jan 9, 2011
Completion
Jan 9, 2011
Results posted
May 23, 2022
Last update
Sep 21, 2022

Study contacts

MD
study director · Amgen
View the source record on ClinicalTrials.gov ↗

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