Single Ascending Dose Study of MEDI1341 in Healthy Volunteers

A Phase 1 study testing MEDI1341 in people with Parkinson's Disease, run by AstraZeneca at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a study of single ascending intravenous doses of MEDI1341 or placebo in up to 48 healthy volunteers, aged 18 to 65 years. The study will include up to 6 planned cohorts; each cohort will comprise 8 participants. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Parkinson's Disease
What is being tested?: MEDI1341
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 2 sitesUnited States
Study dates: 17 Oct 2017to 31 Mar 2021
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

Participants must be healthy, with no clinically significant abnormality identified on the medical or laboratory evaluation at screening
Participants must weigh ≥50 kg and must have a body mass index between 18 and 32 kg/m^2, inclusive
Participants must have a 12-lead electrocardiogram recorded at screening that is normal for the appropriate age group and shows no abnormalities that will compromise safety in this study
Participants must have no clinically significant findings on the clinical neurological examinations at screening and at baseline or on the ophthalmic examination at screening.

Who cannot join

Nicotine use within 6 months before screening
Considered to be at a high risk of developing a stroke
Significant medical history of dizziness, blackouts, fainting, or vaso-vagal attacks
History of any significant ophthalmic disorder, including congenital, genetic or acquired conditions affecting the retina or choroid
History of severe allergy or history of hypersensitivity to immunizations or immunoglobulins
History of any significant psychiatric disorder

Show all 14Show fewer

History of alcohol abuse
History of cancer within 5 years of screening
History of drug abuse
Any contraindication to Lumbar Puncture
Any clinically significant abnormality in ECG rhythm, conduction or morphology
Positive serologic findings at screening for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen, or hepatitis C virus antibodies
Use of prescription or non-prescription drugs
For female participants, a positive serum or urine pregnancy test result at screening

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Research Site
Dallas, Texas, 75247
Research Site
Madison, Wisconsin, 53704

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI1341 in Healthy Male and Female Volunteers

Each participant will receive a single 60 minute intravenous infusion of MEDI1341 or placebo and will undergo scheduled assessments over a period of 13 weeks.

The main aim of the study is to assess the safety and tolerability of single doses of MEDI1341 in healthy volunteers.

Read the detailed description

This is a randomized, double-blind, placebo-controlled study of single ascending intravenous doses of MEDI1341 in male and nonfertile female healthy volunteers, aged 18 to 65 years.

The study will include up to 6 planned cohorts; each cohort will comprise 8 participants. Within each cohort, 6 participants will be randomized to receive MEDI1341 and 2 will be randomized to receive placebo. A Safety Review Committee will review data from each cohort before progression to the next higher dose cohort occurs. On Day 1, each randomized participant will receive a single 60 minute intravenous infusion of MEDI1341 or placebo and will undergo scheduled safety, pharmacokinetic, pharmacodynamic, and immunogenicity assessments. Additional study assessments will occur on Days 2, 4, 8, 15, 22, 29, 43, 57, and 92.

Conditions: Parkinson's Disease
Being tested: MEDI1341, Placebo
Keywords: Healthy Volunteers, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MEDI1341Drug
Also called TAK-341
Participants will receive IV infusion of MEDI1341 doses as stated in the arms' description.
PlaceboDrug
Participants will receive IV infusion of placebo matched to MEDI1341.

Study groups in NCT03272165
Study group	Role	What they receive
Placebo	Placebo comparator	Participants will receive a single intravenous (IV) infusion of placebo matched to MEDI1341 and will be followed up for 13 weeks. Receives: Drug: Placebo
Cohort 1: MEDI1341 Dose 1	Experimental	Participants will receive a single IV infusion of MEDI1341 Dose 1 and will be followed up for 13 weeks. Receives: Drug: MEDI1341
Cohort 2: MEDI1341 Dose 2	Experimental	Participants will receive a single IV infusion of MEDI1341 Dose 2 and will be followed up for 13 weeks. Receives: Drug: MEDI1341
Cohort 3: MEDI1341 Dose 3	Experimental	Participants will receive a single IV infusion of MEDI1341 Dose 3 and will be followed up for 13 weeks. Receives: Drug: MEDI1341
Cohort 4: MEDI1341 Dose 4	Experimental	Participants will receive a single IV infusion of MEDI1341 Dose 4 and will be followed up for 13 weeks. Receives: Drug: MEDI1341
Cohort 5: MEDI1341 Dose 5	Experimental	Participants will receive a single IV infusion of MEDI1341 Dose 5 and will be followed up for 13 weeks. Receives: Drug: MEDI1341
Cohort 6: MEDI1341 Dose 6	Experimental	Participants will receive a single IV infusion of MEDI1341 Dose 6 and will be followed up for 13 weeks. Receives: Drug: MEDI1341

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) and Treatment Emergent Serious Adverse Events (TESAEs)
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.
Measured: Day 1 through 92 days after a single dose of study drug
Number of Participants With Abnormal Vital Signs, Physical and Neurological Examinations, and Body Weight Measurements Reported as TEAEs
Vital signs assessment included body temperature, respiration rate, pulse rate, and blood pressure. Participants with abnormal vital signs, physical and neurological examinations, and body weight measurements reported as TEAEs are reported.
Measured: Day 1 through 92 days after a single dose of study drug
Change from Baseline in 12-Lead Electrocardiogram (ECG) Data in Paper and Digital Recordings (PR Interval, QRS Duration, QT Interval, QTcF Interval, and RR Interval)
Changes from baseline in 12-Lead ECG data in paper recordings (PR interval, QRS duration, QT interval, and QTcF interval) and digital recordings (PR interval, QRS duration, QT interval, QTcF interval, and RR interval) are reported.
Measured: 12-lead paper ECG: Baseline (Day -49) to Day 92; Digital ECG: Baseline (Day 1) to Day 92
Change from Baseline in Heart Rate by 12-Lead ECG in Paper and Digital Recordings
Change from baseline in heart rate by 12-Lead ECG in paper and digital recordings are reported.
Measured: 12-lead paper ECG: Baseline (Day -49) to Day 92; Digital ECG: Baseline (Day 1) to Day 92
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs
Laboratory assessment included hematology, clinical chemistry, and urinalysis. Participants with abnormal laboratory parameters reported as TEAEs are reported.
Measured: Day 1 through 92 days after a single dose of study drug
Number of Abnormal Findings for Ophthalmic Assessment (Ophthalmic Examination and Slit-lamp Examination) for Placebo and Cohorts 4 to 6 at Follow-up Visit
Number of abnormal findings for ophthalmic assessment (ophthalmic examination and slit-lamp examination) at follow-up visit (Day 57) are reported.
Measured: Follow-up Visit (Day 57)
Intraocular Pressure at Screening for Placebo and Cohorts 4 to 6
Intraocular pressure at Screening (Day -49) is reported.
Measured: Screening (Day -49)
Intraocular Pressure at Day 29 for Placebo and Cohorts 4 to 6
Intraocular pressure at Day 29 is reported.
Measured: Day 29
Intraocular Pressure at Day 92 for Placebo and Cohorts 4 to 6
Intraocular pressure at Day 92 is reported.
Measured: Day 92
Number of Participants With Injection Site Reactions
Participants who had injection site reactions (bleeding, bruising, erythema, swelling, or induration) on Day 1 are reported.
Measured: Day 1
Visual Analogue Scale (VAS) Pain Score for Site Reaction Pain
The VAS (0 to 10 cm) was used to describe reaction site pain. The score 0 means 'no pain at all' and 10 score means 'worst pain imaginable'. The higher the VAS score, the greater the reaction site pain experienced.
Measured: Day 1 (within 24 hours after end of infusion)
Number of Participants With Suicidal Ideation and Suicidal Behavior Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviours, and has a binary response (yes/no).
- Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent.
- Suicidal Behaviour: a "yes" answer to any of 5 suicidal behaviour questions: preparatory acts or behaviour, aborted attempt, interrupted attempt, actual attempt (non-fatal), completed suicide.
Measured: Screening (Day -49) through 92 days after a single dose of study drug
Number of Participants With Montreal Cognitive Assessment (MoCA) Total Score at Screening (Day -1)
The MoCA is s standardized cognitive screening tool for mild cognitive impairment and dementia. The total score was used as outcome measure and this score ranges from 0-31, with higher scores representing better cognitive ability and scores below 26 were considered as cognitive dysfunction.
Measured: Screening (Day -1)
Number of Participants With MoCA Total Score at Day 92
The MoCA is s standardized cognitive screening tool for mild cognitive impairment and dementia. The total score was used as outcome measure and this score ranges from 0-31, with higher scores representing better cognitive ability and scores below 26 were considered as cognitive dysfunction.
Measured: Day 92

Secondary outcomes (11)

Maximum Observed Serum Concentration (Cmax) of MEDI1341
The Cmax of MEDI1341 is reported.
Measured: Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Time to Maximum Serum Concentration (tmax) of MEDI1341
The tmax of MEDI1341 is reported.
Measured: Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) of MEDI1341
The AUC0-t of MEDI1341 is reported.
Measured: Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) of MEDI1341
The AUC0-∞ of MEDI1341 is reported.
Measured: Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Terminal Half-life (t1/2λz) of MEDI1341
The t1/2λz of MEDI1341 is reported.
Measured: Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Serum Clearance (CL) of MEDI1341
The CL of MEDI1341 is reported.
Measured: Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Volume of Distribution at Steady State (Vss) of MEDI1341
The Vss of MEDI1341 is reported.
Measured: Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Mean Residence Time (MRT) of MEDI1341
The MRT of MEDI1341 is reported.
Measured: Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Percentage Change From Baseline in Plasma Concentrations of Total α-synuclein
Maximum change from baseline through Day 92 and change from baseline at Day 92 in plasma concentrations of total α-synuclein are reported.
Measured: Baseline (Day 1 predose) through Day 92
Percentage Change From Baseline in Cerebrospinal Fluid Concentrations of Free α-synuclein
Change from baseline in cerebrospinal fluid concentrations of free α-synuclein is reported.
Measured: Baseline (Day 1 predose) and Day 29
Percentage of Participants With Positive Antidrug Antibodies (ADAs) to MEDI1341 by Titer Levels at Day 92
Percentage of participants with positive ADAs to MEDI1341 by titer levels are reported.
Measured: Day 92

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Oct 201731 Mar 2021

First posted5 Sep 2017
Study start17 Oct 2017
Primary completion31 Mar 2021
Study completion31 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants are randomized to one of two groups within a cohort of 8 participants (N=6 MEDI1341; N=2 placebo)
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03272165
Sponsor's protocol ID: D6340C00001
Status last verified: Jun 2022
First submitted: 29 Jun 2017
Last updated: 9 Jun 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymised individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI1341 in Healthy Male and Female Volunteers
ClinicalTrials.gov ID: NCT03272165
Acronym / sponsor ID: D6340C00001
Conditions: Parkinson's Disease
Keywords: Healthy Volunteers, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Covance, MMS Holdings, Inc, Catalent, Takeda
Study start: 17 Oct 2017 (actual)
Primary completion: 31 Mar 2021 (actual)
Study completion: 31 Mar 2021 (actual)
First posted: 5 Sep 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.

Each participant will receive a single 60 minute intravenous infusion of MEDI1341 or placebo and will undergo scheduled assessments over a period of 13 weeks.

The main aim of the study is to assess the safety and tolerability of single doses of MEDI1341 in healthy volunteers.

Detailed description

This is a randomized, double-blind, placebo-controlled study of single ascending intravenous doses of MEDI1341 in male and nonfertile female healthy volunteers, aged 18 to 65 years.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 7
Model description: Participants are randomized to one of two groups within a cohort of 8 participants (N=6 MEDI1341; N=2 placebo)

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive a single intravenous (IV) infusion of placebo matched to MEDI1341 and will be followed up for 13 weeks.
Cohort 1: MEDI1341 Dose 1	Experimental	Drug: MEDI1341Participants will receive a single IV infusion of MEDI1341 Dose 1 and will be followed up for 13 weeks.
Cohort 2: MEDI1341 Dose 2	Experimental	Drug: MEDI1341Participants will receive a single IV infusion of MEDI1341 Dose 2 and will be followed up for 13 weeks.
Cohort 3: MEDI1341 Dose 3	Experimental	Drug: MEDI1341Participants will receive a single IV infusion of MEDI1341 Dose 3 and will be followed up for 13 weeks.
Cohort 4: MEDI1341 Dose 4	Experimental	Drug: MEDI1341Participants will receive a single IV infusion of MEDI1341 Dose 4 and will be followed up for 13 weeks.
Cohort 5: MEDI1341 Dose 5	Experimental	Drug: MEDI1341Participants will receive a single IV infusion of MEDI1341 Dose 5 and will be followed up for 13 weeks.
Cohort 6: MEDI1341 Dose 6	Experimental	Drug: MEDI1341Participants will receive a single IV infusion of MEDI1341 Dose 6 and will be followed up for 13 weeks.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Participants must be healthy, with no clinically significant abnormality identified on the medical or laboratory evaluation at screening
Participants must weigh ≥50 kg and must have a body mass index between 18 and 32 kg/m^2, inclusive
Participants must have a 12-lead electrocardiogram recorded at screening that is normal for the appropriate age group and shows no abnormalities that will compromise safety in this study
Participants must have no clinically significant findings on the clinical neurological examinations at screening and at baseline or on the ophthalmic examination at screening.

Key exclusion criteria (14 listed)

Nicotine use within 6 months before screening
Considered to be at a high risk of developing a stroke
Significant medical history of dizziness, blackouts, fainting, or vaso-vagal attacks
History of any significant ophthalmic disorder, including congenital, genetic or acquired conditions affecting the retina or choroid
History of severe allergy or history of hypersensitivity to immunizations or immunoglobulins

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
MEDI1341Also: TAK-341Participants will receive IV infusion of MEDI1341 doses as stated in the arms' description.	Drug	Cohort 1: MEDI1341 Dose 1, Cohort 2: MEDI1341 Dose 2, Cohort 3: MEDI1341 Dose 3, Cohort 4: MEDI1341 Dose 4, Cohort 5: MEDI1341 Dose 5, Cohort 6: MEDI1341 Dose 6
PlaceboParticipants will receive IV infusion of placebo matched to MEDI1341.	Drug	Placebo

Primary outcome

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: Day 1 through 92 days after a single dose of study drug
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.
Number of Participants With Abnormal Vital Signs, Physical and Neurological Examinations, and Body Weight Measurements Reported as TEAEs
Time frame: Day 1 through 92 days after a single dose of study drug
Vital signs assessment included body temperature, respiration rate, pulse rate, and blood pressure. Participants with abnormal vital signs, physical and neurological examinations, and body weight measurements reported as TEAEs are reported.
Change from Baseline in 12-Lead Electrocardiogram (ECG) Data in Paper and Digital Recordings (PR Interval, QRS Duration, QT Interval, QTcF Interval, and RR Interval)
Time frame: 12-lead paper ECG: Baseline (Day -49) to Day 92; Digital ECG: Baseline (Day 1) to Day 92
Changes from baseline in 12-Lead ECG data in paper recordings (PR interval, QRS duration, QT interval, and QTcF interval) and digital recordings (PR interval, QRS duration, QT interval, QTcF interval, and RR interval) are reported.
Change from Baseline in Heart Rate by 12-Lead ECG in Paper and Digital Recordings
Time frame: 12-lead paper ECG: Baseline (Day -49) to Day 92; Digital ECG: Baseline (Day 1) to Day 92
Change from baseline in heart rate by 12-Lead ECG in paper and digital recordings are reported.
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs
Time frame: Day 1 through 92 days after a single dose of study drug
Laboratory assessment included hematology, clinical chemistry, and urinalysis. Participants with abnormal laboratory parameters reported as TEAEs are reported.
Number of Abnormal Findings for Ophthalmic Assessment (Ophthalmic Examination and Slit-lamp Examination) for Placebo and Cohorts 4 to 6 at Follow-up Visit
Time frame: Follow-up Visit (Day 57)
Number of abnormal findings for ophthalmic assessment (ophthalmic examination and slit-lamp examination) at follow-up visit (Day 57) are reported.
Intraocular Pressure at Screening for Placebo and Cohorts 4 to 6
Time frame: Screening (Day -49)
Intraocular pressure at Screening (Day -49) is reported.
Intraocular Pressure at Day 29 for Placebo and Cohorts 4 to 6
Time frame: Day 29
Intraocular pressure at Day 29 is reported.
Intraocular Pressure at Day 92 for Placebo and Cohorts 4 to 6
Time frame: Day 92
Intraocular pressure at Day 92 is reported.
Number of Participants With Injection Site Reactions
Time frame: Day 1
Participants who had injection site reactions (bleeding, bruising, erythema, swelling, or induration) on Day 1 are reported.
Visual Analogue Scale (VAS) Pain Score for Site Reaction Pain
Time frame: Day 1 (within 24 hours after end of infusion)
The VAS (0 to 10 cm) was used to describe reaction site pain. The score 0 means 'no pain at all' and 10 score means 'worst pain imaginable'. The higher the VAS score, the greater the reaction site pain experienced.
Number of Participants With Suicidal Ideation and Suicidal Behavior Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Screening (Day -49) through 92 days after a single dose of study drug
The C-SSRS is a scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviours, and has a binary response (yes/no). * Suicidal Ideation: a "yes" answer to any one of 5 suicidal ideation questions: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intent to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. * Suicidal Behaviour: a "yes" answer to any of 5 suicidal behaviour questions: preparatory acts or behaviour, aborted attempt, interrupted attempt, actual attempt (non-fatal), completed suicide.
Number of Participants With Montreal Cognitive Assessment (MoCA) Total Score at Screening (Day -1)
Time frame: Screening (Day -1)
The MoCA is s standardized cognitive screening tool for mild cognitive impairment and dementia. The total score was used as outcome measure and this score ranges from 0-31, with higher scores representing better cognitive ability and scores below 26 were considered as cognitive dysfunction.
Number of Participants With MoCA Total Score at Day 92
Time frame: Day 92
The MoCA is s standardized cognitive screening tool for mild cognitive impairment and dementia. The total score was used as outcome measure and this score ranges from 0-31, with higher scores representing better cognitive ability and scores below 26 were considered as cognitive dysfunction.

11 secondary outcomes

Maximum Observed Serum Concentration (Cmax) of MEDI1341
Time frame: Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Time to Maximum Serum Concentration (tmax) of MEDI1341
Time frame: Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Area Under the Serum Concentration-time Curve From Time 0 to the Last Measurable Concentration (AUC0-t) of MEDI1341
Time frame: Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-∞) of MEDI1341
Time frame: Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Terminal Half-life (t1/2λz) of MEDI1341
Time frame: Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Serum Clearance (CL) of MEDI1341
Time frame: Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Volume of Distribution at Steady State (Vss) of MEDI1341
Time frame: Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Mean Residence Time (MRT) of MEDI1341
Time frame: Day 1 (predose; 0 minute and 8 and 24 hours at the end of infusion), and Days 4, 8, 15, 22, 29, 43, 57, and 92
Percentage Change From Baseline in Plasma Concentrations of Total α-synuclein
Time frame: Baseline (Day 1 predose) through Day 92
Percentage Change From Baseline in Cerebrospinal Fluid Concentrations of Free α-synuclein
Time frame: Baseline (Day 1 predose) and Day 29
Percentage of Participants With Positive Antidrug Antibodies (ADAs) to MEDI1341 by Titer Levels at Day 92
Time frame: Day 92

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 9 Jun 2022.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymised individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

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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.

Jeanelle Kam, MD, CPI principal investigator

Covance Dallas CRU, USA

John E Blanchard, MD principal investigator

Covance Madison CRU, USA

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 MEDI1341 in people with Parkinson's Disease, run by AstraZeneca at 2 sites in United States.

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 4 inclusion and 14 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 9 Jun 2022. 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 States. 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) and Treatment Emergent Serious Adverse Events (TESAEs) (time frame: Day 1 through 92 days after a single dose of study drug). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03272165.

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 9 Jun 2022.