Part I (SAD) - Healthy ParticipantsPhase 1NCT03096795
Safety and Tolerability of MEDI3506 in Healthy Participants, in Participants With COPD and Healthy Japanese Participants
A Phase 1 study testing MEDI3506 in people with Part I (SAD) - Healthy Participants and Part II (MAD) - Chronic Obstructive Pulmonary Disease, run by MedImmune LLC at 2 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Part I (SAD) - Healthy Participants, Part II (MAD) - Chronic Obstructive Pulmonary Disease, Part III (J-SD) - Healthy Japanese Participants
- What is being tested?
- MEDI3506
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 15 May 2017to 30 Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers aged 18 through 55 years at the time of consent.
- Non-smokers, healthy current smokers, and ex-smokers are permitted.
- Pre-bronchodilator forced expiratory volume in 1 second (FEV1) >= 80% predicted (using the Global Lung Initiative [GLI] predicted values) at screening.
- Body mass index (BMI) of 19.0 through 32.0 kg/m^2 at screening.
- Current history of mild atopy.
- Aged 40 through 80 years at the time of screening.
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- BMI of 19.0 through 35.0 kg/m^2 at screening.
- Participants must be current on pneumococcus and annual influenza vaccines.
- Documented history of COPD with a post-bronchodilator FEV1/force vital capacity (FVC) <0.70 and a post-bronchodilator FEV1 ≥50% predicted at screening.
- Clinically stable and free from an acute exacerbation of COPD for 8 weeks prior to Day 1.
- Current or ex-smoker with a tobacco history of ≥10 pack-years.
- Japanese participants must have been born in Japan, have both parents and grandparents of Japanese origin, and not have lived outside of Japan for more than 5 years.
- Healthy participants aged 20 through 55 years at the time of consent.
- Non-smokers, healthy current smokers, and ex-smokers are permitted.
- BMI of 18.0 through 32.0 kg/m^2 at screening.
Who cannot join
- Concurrent enrollment in another clinical study involving a study treatment.
- Received administration of study drug or participated in a device trial within 3 months, prior to screening (Visit 1).
- Participant is a participating investigator, sub-investigator, study coordinator or employee of the participating site, or is a first-degree relative of the aforementioned.
- Any active medical or psychiatric condition or other reason which, in the opinion of the investigator or medical monitor, may compromise the safety of the participant in the study or interfere with evaluation of the investigational product or reduce the participant's ability to participate in the study.
- Any clinically relevant abnormal findings on physical examination of the cardiovascular system including electrocardiogram (ECG) and vital signs at screening or randomization.
- Abnormal vital signs, after 10 minutes supine rest.
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- Concurrent enrolment in another clinical study involving investigational treatment.
- Received administration of study drug or participated in a device trial within 3 months, prior to screening (Visit 1).
- Participant is a participating investigator, sub-investigator, study coordinator, or employee of the participating site, or is a first-degree relative of the aforementioned.
- 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:
- Uncontrolled diabetes
- Hypertension during the screening period
- Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart failure
- Clinically significant Aortic stenosis
- Pulmonary Arterial Hypertension
- Concurrent enrolment in another clinical study involving study treatment.
- Received administration of study drug or participated in a device trial within 3 months, prior to screening (Visit 1).
- Any active medical or psychiatric condition or other reason which, in the opinion of the investigator or medical monitor, may compromise the safety of the participant in the study or interfere with evaluation of the study product or reduce the participant's ability to participate in the study.
- Any clinically relevant abnormal findings on physical examination of the cardiovascular system including ECG and vital signs at screening, and Day 1(pre-dose).
- Any other clinically relevant abnormal findings on physical examination or laboratory testing including hematology, coagulation, clinical chemistry or urinalysis at screening or randomisation.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Research Site
London, HA1 3UJ
Research Site
Manchester, M23 9QZ
About this study
Official title: Safety, Tolerability, Pharmacokinetics and Immunogenicity of MEDI3506 Administered as Single Ascending Doses in Healthy Adult Subjects, as Multiple Ascending Doses in COPD Subjects and Single Dose in Healthy Japanese Subjects
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.
Read the detailed description
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
- Conditions
- Part I (SAD) - Healthy Participants, Part II (MAD) - Chronic Obstructive Pulmonary Disease, Part III (J-SD) - Healthy Japanese Participants
- Being tested
- MEDI3506, Placebo
- Keywords
- MEDI3506, Safety, Tolerability, Pharmacokinetics, Immunogenicity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI3506Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Placebo | Placebo comparator | 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. Receives: Drug: MEDI3506; Drug: Placebo |
| Part 1: MEDI3506 SC Dose 1 | Experimental | Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 1 subcutaneously. Receives: Drug: MEDI3506 |
| Part 1: MEDI3506 SC Dose 2 | Experimental | Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 2 subcutaneously. Receives: Drug: MEDI3506 |
| Part 1: MEDI3506 SC Dose 3 | Experimental | Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 3 subcutaneously. Receives: Drug: MEDI3506 |
| Part 1: MEDI3506 SC Dose 4 | Experimental | Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 4 subcutaneously. Receives: Drug: MEDI3506 |
| Part 1: MEDI3506 SC Dose 5 | Experimental | Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 5 subcutaneously. Receives: Drug: MEDI3506 |
| Part 1: MEDI3506 SC Dose 6 | Experimental | Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 6 subcutaneously. Receives: Drug: MEDI3506 |
| Part 1: MEDI3506 IV Dose 6 | Experimental | Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 6 intravenously. Receives: Drug: MEDI3506 |
| Part 2: Placebo | Placebo comparator | 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). Receives: Drug: MEDI3506; Drug: Placebo |
| Part 2: MEDI3506 SC Dose 4 | Experimental | 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). Receives: Drug: MEDI3506 |
| Part 2: MEDI3506 SC Dose 5 | Experimental | 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). Receives: Drug: MEDI3506 |
| Part 2: MEDI3506 SC Dose 6 | Experimental | 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). Receives: Drug: MEDI3506 |
| Part 3: Placebo | Placebo comparator | Healthy Japanese participants will receive a single dose of placebo matched to MEDI3506 intravenously. Receives: Drug: MEDI3506; Drug: Placebo |
| Part 3: MEDI3506 IV Dose 6 | Experimental | Healthy Japanese participants will receive a single MEDI3506 Dose 6 intravenously. Receives: Drug: MEDI3506 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1) and Day 169
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start15 May 2017
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Part I (SAD) - Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Muna Albayaty, MBChB, FFPM. MSc, Principal investigator, ParexelDavid Singh, MD, Principal investigator, Medicines Evaluation Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096795
- Sponsor's protocol ID
- D9180C00001
- Status last verified
- Sep 2020
- First submitted
- 1 Mar 2017
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, Pharmacokinetics and Immunogenicity of MEDI3506 Administered as Single Ascending Doses in Healthy Adult Subjects, as Multiple Ascending Doses in COPD Subjects and Single Dose in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT03096795
- Acronym / sponsor ID
- D9180C00001
- Conditions
- Part I (SAD) - Healthy Participants, Part II (MAD) - Chronic Obstructive Pulmonary Disease, Part III (J-SD) - Healthy Japanese Participants
- Keywords
- MEDI3506, Safety, Tolerability, Pharmacokinetics, Immunogenicity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- 15 May 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Part 1: Placebo | Placebo comparator | Drug: MEDI3506, Drug: PlaceboHealthy 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. |
| Part 1: MEDI3506 SC Dose 1 | Experimental | Drug: MEDI3506Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 1 subcutaneously. |
| Part 1: MEDI3506 SC Dose 2 | Experimental | Drug: MEDI3506Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 2 subcutaneously. |
| Part 1: MEDI3506 SC Dose 3 | Experimental | Drug: MEDI3506Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 3 subcutaneously. |
| Part 1: MEDI3506 SC Dose 4 | Experimental | Drug: MEDI3506Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 4 subcutaneously. |
| Part 1: MEDI3506 SC Dose 5 | Experimental | Drug: MEDI3506Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 5 subcutaneously. |
| Part 1: MEDI3506 SC Dose 6 | Experimental | Drug: MEDI3506Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 6 subcutaneously. |
| Part 1: MEDI3506 IV Dose 6 | Experimental | Drug: MEDI3506Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 6 intravenously. |
| Part 2: Placebo | Placebo comparator | Drug: MEDI3506, Drug: PlaceboParticipants 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). |
| Part 2: MEDI3506 SC Dose 4 | Experimental | Drug: MEDI3506Participants 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). |
| Part 2: MEDI3506 SC Dose 5 | Experimental | Drug: MEDI3506Participants 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). |
| Part 2: MEDI3506 SC Dose 6 | Experimental | Drug: MEDI3506Participants 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). |
| Part 3: Placebo | Placebo comparator | Drug: MEDI3506, Drug: PlaceboHealthy Japanese participants will receive a single dose of placebo matched to MEDI3506 intravenously. |
| Part 3: MEDI3506 IV Dose 6 | Experimental | Drug: MEDI3506Healthy Japanese participants will receive a single MEDI3506 Dose 6 intravenously. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Healthy volunteers aged 18 through 55 years at the time of consent.
- Non-smokers, healthy current smokers, and ex-smokers are permitted.
- Pre-bronchodilator forced expiratory volume in 1 second (FEV1) >= 80% predicted (using the Global Lung Initiative [GLI] predicted values) at screening.
- Body mass index (BMI) of 19.0 through 32.0 kg/m^2 at screening.
- Current history of mild atopy.
Key exclusion criteria (20 listed)
- Concurrent enrollment in another clinical study involving a study treatment.
- Received administration of study drug or participated in a device trial within 3 months, prior to screening (Visit 1).
- Participant is a participating investigator, sub-investigator, study coordinator or employee of the participating site, or is a first-degree relative of the aforementioned.
- Any active medical or psychiatric condition or other reason which, in the opinion of the investigator or medical monitor, may compromise the safety of the participant in the study or interfere with evaluation of the investigational product or reduce the participant's ability to participate in the study.
- Any clinically relevant abnormal findings on physical examination of the cardiovascular system including electrocardiogram (ECG) and vital signs at screening or randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI3506Healthy 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. | Drug | Part 1: MEDI3506 IV Dose 6, Part 1: MEDI3506 SC Dose 1, Part 1: MEDI3506 SC Dose 2, Part 1: MEDI3506 SC Dose 3, Part 1: MEDI3506 SC Dose 4, Part 1: MEDI3506 SC Dose 5, Part 1: MEDI3506 SC Dose 6, Part 1: Placebo, Part 2: MEDI3506 SC Dose 4, Part 2: MEDI3506 SC Dose 5, Part 2: MEDI3506 SC Dose 6, Part 2: Placebo, Part 3: MEDI3506 IV Dose 6, Part 3: Placebo |
| PlaceboHealthy 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. | Drug | Part 1: Placebo, Part 2: Placebo, Part 3: Placebo |
Primary outcome
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
Time frame: From Day 1 through Day 169
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.
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
Time frame: Day 169
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.
Changes From Baseline in Blood Pressure at Day 169 in Part 1, Part 2, and Part 3
Time frame: Day 169
Change from baseline in blood pressure at Day 169 in Part 1, Part 2, and Part 3 are reported.
Changes From Baseline in Pulse Rate at Day 169 in Part 1, Part 2, and Part 3
Time frame: Baseline (Day 1) and Day 169
Change from baseline in pulse rate at Day 169 in Part 1, Part 2, and Part 3 is reported.
Changes From Baseline in Respiratory Rate at Day 169 in Part 1, Part 2, and Part 3
Time frame: Baseline (Day 1) and Day 169
Change from baseline in respiratory rate at Day 169 in Part 1, Part 2, and Part 3 are reported.
Changes From Baseline in Body Temperature Rate at Day 169 in Part 1, Part 2, and Part 3
Time frame: Baseline (Day 1) and Day 169
Change from baseline in body temperature at Day 169 in Part 1, Part 2, and Part 3 are reported.
Number of Participants With Change From Baseline in QTcF in Part 1, Part 2, and Part 3
Time frame: Baseline (Day 1) and Day 169
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.
9 secondary outcomes
Maximum Observed Concentration (Cmax) of MEDI3506 After Single Dose for Part 1 and Part 3
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
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
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
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
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
Time frame: Day 1 (predose), Day 3, Day 8, Day 15 (predose)
Trough Serum Concentration (Ctrough) of MEDI3506 After 3rd Dose in Part 2
Time frame: Day 29 (predose), Day 36, and Day 43
Terminal Elimination Half-life (t1/2) of MEDI3506 in Part 2
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- Results of this clinical trial are available on www.astrazenecaclinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muna Albayaty, MBChB, FFPM. MSc principal investigator
Parexel
David Singh, MD principal investigator
Medicines Evaluation Unit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI3506 in people with Part I (SAD) - Healthy Participants and Part II (MAD) - Chronic Obstructive Pulmonary Disease, run by MedImmune LLC at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From Day 1 through Day 169). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2020.