A Phase 1 interventional study of MEDI3506 and Placebo in Part I (SAD) - Healthy Participants, Part II (MAD) - Chronic Obstructive Pulmonary Disease and Part III (J-SD) - Healthy Japanese Participants, sponsored by MedImmune LLC. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-05.
Sponsored by MedImmune LLC · Phase 1, Interventional, and Basic science
This is a Phase 1, randomised, blinded, placebo controlled, study designed to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity response to single and multiple doses of MEDI3506.
This is a Phase 1, randomised, blinded, placebo controlled, study designed to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity response to single and multiple doses of MEDI3506 administered by either subcutaneous (SC) or intravenous (IV) routes.
Part I: Single Ascending Doses in Healthy Participants with a History of Mild Atopy
Part II: Multiple Ascending Doses in Participants with Global Initiative for Chronic Obstructive Lung Disease (GOLD) I-II Chronic Obstructive Pulmonary Disease (COPD)
Part III: Single Dose in Healthy Japanese Participants
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 88 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →MedImmune LLC is the lead sponsor of 265 studies on the registry; none are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 28 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria Part 1
Inclusion Criteria Part 2
Inclusion Criteria Part 3
Exclusion Criteria Part 1
Exclusion Criteria Part 2
Any active medical or psychiatric condition or other reason that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of participant's safety or study results. This includes, but is not limited to:
Exclusion Criteria Part 3
Healthy participants with a history of mild atopy and proven sensitivity to house dust mite (HDM) will receive a single dose of placebo matched to MEDI3506 subcutaneously or intravenously.
Drug: MEDI3506 · Drug: Placebo
Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 1 subcutaneously.
Drug: MEDI3506
Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 2 subcutaneously.
Drug: MEDI3506
Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 3 subcutaneously.
Drug: MEDI3506
Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 4 subcutaneously.
Drug: MEDI3506
Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 5 subcutaneously.
Drug: MEDI3506
Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 6 subcutaneously.
Drug: MEDI3506
Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 6 intravenously.
Drug: MEDI3506
Participants with COPD will receive 3 administration of placebo matched to MEDI3506 subcutaneously two weeks apart over a 4-week dosing period (doses on Days 1, 15, and 29).
Drug: MEDI3506 · Drug: Placebo
Participants with COPD will receive 3 administration of MEDI3506 Dose 4 subcutaneously two weeks apart over a 4-week dosing period (doses on Days 1, 15, and 29).
Drug: MEDI3506
Participants with COPD will receive 3 administration of MEDI3506 Dose 5 subcutaneously two weeks apart over a 4-week dosing period (doses on Days 1, 15, and 29).
Drug: MEDI3506
Participants with COPD will receive 3 administration of MEDI3506 Dose 6 subcutaneously two weeks apart over a 4-week dosing period (doses on Days 1, 15, and 29).
Drug: MEDI3506
Healthy Japanese participants will receive a single dose of placebo matched to MEDI3506 intravenously.
Drug: MEDI3506 · Drug: Placebo
Healthy Japanese participants will receive a single MEDI3506 Dose 6 intravenously.
Drug: MEDI3506
Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 1 or Dose 2 or Dose 3 or Dose 4 or Dose 5 or Dose 6 subcutaneously and Dose 6 intravenously in Part 1. Participants with COPD will receive 3 administration of MEDI3506 Dose 4 or Dose 5 or Dose 6 subcutaneously two weeks apart over a 4-week dosing period in Part 2. Healthy Japanese participants will receive a single dose of MEDI3506 Dose 6 intravenously in Part 3.
Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single dose of placebo matched to MEDI3506 subcutaneously or intravenously in Part 1. Participants with COPD will receive 3 administration of placebo matched to MEDI3506 subcutaneously two weeks apart over a 4-week dosing period in Part 2. Healthy Japanese participants will receive a single dose of placebo matched to MEDI3506 intravenously in Part 3.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (TEAESI) in Part 1, Part 2, and Part 3
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. An adverse event of special interest (AESI) was defined as any serious or nonserious event of scientific and medical interest specific to understand the study drug.
Time frame: From Day 1 through Day 169
Number of Participants With Grade 2 or More Toxicity Grades Reported in Laboratory Parameters at Day 169 for Part 1, Part 2, and Part 3
Number of participants with Grade 2 or more toxicity grades reported in laboratory parameters are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of hematology and serum chemistry.
Time frame: Day 169
Changes From Baseline in Blood Pressure at Day 169 in Part 1, Part 2, and Part 3
Change from baseline in blood pressure at Day 169 in Part 1, Part 2, and Part 3 are reported.
Time frame: Day 169
Changes From Baseline in Pulse Rate at Day 169 in Part 1, Part 2, and Part 3
Change from baseline in pulse rate at Day 169 in Part 1, Part 2, and Part 3 is reported.
Time frame: Baseline (Day 1) and Day 169
Changes From Baseline in Respiratory Rate at Day 169 in Part 1, Part 2, and Part 3
Change from baseline in respiratory rate at Day 169 in Part 1, Part 2, and Part 3 are reported.
Time frame: Baseline (Day 1) and Day 169
Changes From Baseline in Body Temperature Rate at Day 169 in Part 1, Part 2, and Part 3
Change from baseline in body temperature at Day 169 in Part 1, Part 2, and Part 3 are reported.
Time frame: Baseline (Day 1) and Day 169
Number of Participants With Change From Baseline in QTcF in Part 1, Part 2, and Part 3
Number of participants with change from basleine in QTcF in Part 1, Part 2, and Part 3 are reported. The change from baseline in QTcF at Day 169 data are reported in 3 categories as: \<= 30 msec, \> 30 to \<= 60 msec, and \> 60 msec.
Time frame: Baseline (Day 1) and Day 169
Maximum Observed Concentration (Cmax) of MEDI3506 After Single Dose for Part 1 and Part 3
The Cmax of MEDI3506 after single dose for Part 1 and Part 3 are reported.
Time frame: Day 1 (predose for all arms; except predose and end of infusion for MEDI3506 IV Dose 6 arms), Day 2, Day 3, Day 4, Day 5, Day 8, Day 15, Day 29, Day 43, Day 57, Day 85, Day 113, Day 141, and Day 169
Time to Maximum Concentration (Tmax) of MEDI3506 After Single Dose for Part 1 and Part 3
The Tmax of MEDI3506 after single dose for Part 1 and Part 3 is reported.
Time frame: Day 1 (predose for all arms; except predose and end of infusion for MEDI3506 IV Dose 6 arms), Day 2, Day 3, Day 4, Day 5, Day 8, Day 15, Day 29, Day 43, Day 57, Day 85, Day 113, Day 141, and Day 169
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI3506 After Single Dose for Part 1 and Part 3
The AUC0-inf of MEDI3506 after single dose for Part 1 and Part 3 are reported.
Time frame: Day 1 (predose for all arms; except predose and end of infusion for MEDI3506 IV Dose 6 arms), Day 2, Day 3, Day 4, Day 5, Day 8, Day 15, Day 29, Day 43, Day 57, Day 85, Day 113, Day 141, and Day 169
Terminal Elimination Half-life (t1/2) of MEDI3506 After Single Dose for Part 1 and Part 3
The t1/2 of MEDI3506 after single dose for Part 1 and Part 3 are reported.
Time frame: Day 1 (predose for all arms; except predose and end of infusion for MEDI3506 IV Dose 6 arms), Day 2, Day 3, Day 4, Day 5, Day 8, Day 15, Day 29, Day 43, Day 57, Day 85, Day 113, Day 141, and Day 169
Apparent Clearance (CL/F) of MEDI3506 From Body After Single Dose for Part 1 and Part 3
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Total clearance from the body (CL) from Part 1 and Part 3 after intravenous administration or apparent systemic clearance (CL/F) after subcutaneous administration in Part 1 of the study are reported.
Time frame: Day 1 (predose for all arms; except predose and end of infusion for MEDI3506 IV Dose 6 arms), Day 2, Day 3, Day 4, Day 5, Day 8, Day 15, Day 29, Day 43, Day 57, Day 85, Day 113, Day 141, and Day 169
Trough Serum Concentration (Ctrough) of MEDI3506 After 1st Dose in Part 2
Lowest serum concentration of MEDI3506 observed within the dosing interval after 1st dose in Part 2 is reported.
Time frame: Day 1 (predose), Day 3, Day 8, Day 15 (predose)
Trough Serum Concentration (Ctrough) of MEDI3506 After 3rd Dose in Part 2
Lowest serum concentration of MEDI3506 observed within the dosing interval after 3rd dose in Part 2 is reported.
Time frame: Day 29 (predose), Day 36, and Day 43
Terminal Elimination Half-life (t1/2) of MEDI3506 in Part 2
The t1/2 of MEDI3506 after 3rd dose in Part 2 is reported.
Time frame: Day 36, Day 43, Day 57, Day 85, Day 113, Day 141, and Day 169
Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI3506 treatment in Part 1, Part 2, and Part 3
Number of participants with positive ADA to MEDI3506 treatment after single administration of MEDI3506 (Part 1 and Part 3) and after multiple dose administration of MEDI3506 (Part 2) at any time point during the study are reported.
Time frame: Part 1 and Part 3: Day 1 (predose), Day 29, Day 57, Day 85, Day 113, Day 141, and Day 169; Part 2: Day 1 (predose), Day 29, Day 85, and Day 169
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
MedImmune LLC