Try the modernized beta website. Learn more about the modernization effort.
Working… Menu
Trial record 1 of 2 for:    MEDI1341
Previous Study | Return to List | Next Study

Single Ascending Dose Study of MEDI1341 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03272165
Recruitment Status : Completed
First Posted : September 5, 2017
Last Update Posted : March 17, 2022
MMS Holdings, Inc
Information provided by (Responsible Party):

Brief 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 subjects.

Each subject 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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Drug: MEDI1341 Drug: Placebo Phase 1

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 subjects. Within each cohort, 6 subjects 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 subject 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects are randomised to one of two groups within a cohort of 8 subjects (N=6 MEDI1341; N=2 placebo)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : October 17, 2017
Actual Primary Completion Date : March 31, 2021
Actual Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: MEDI1341 Drug: MEDI1341
Intravenous infusion over 60 minutes
Other Name: TAK-341

Placebo Comparator: Placebo Drug: Placebo
Intravenous infusion over 60 minutes

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 13 weeks ]
    - Incidence, nature, severity and seriousness

  2. Vital Signs [ Time Frame: 13 weeks ]
    - Blood pressure and pulse rate

  3. Oral Body Temperature [ Time Frame: 13 weeks ]
    - in Celsius

  4. Body weight [ Time Frame: 13 weeks ]
    - in kilograms

  5. Height [ Time Frame: 13 weeks ]
    - in meters

  6. Body Mass Index (BMI) [ Time Frame: 13 weeks ]
    - Weight and height will be combined to report BMI in kg/m2

  7. Safety Laboratory tests [ Time Frame: 13 weeks ]
    - Clinical chemistry, hematology, coagulation, urinalysis

  8. Electrocardiograms [ Time Frame: 13 weeks ]
    - rhythm, heart rate, conduction, P-R interval, QRS complex, R-R interval, Q-T interval, and QTcF (Q-T interval corrected by Fridericia's formula)

  9. Ophthalmic assessments [ Time Frame: 13 weeks ]
    • a standardized ophthalmic patient-reported outcome questionnaire
    • visual acuity
    • intraocular pressure
    • corneal thickness
    • slit-lamp examination
    • fundoscopy
    • optical coherence tomography
    • visual field assessment

Secondary Outcome Measures :
  1. Maximum concentration of Medi1341 [ Time Frame: 13 weeks ]
    - Cmax

  2. Time to maximum concentration of Medi1341 [ Time Frame: 13 weeks ]
    - tmax

  3. Area under the concentration - time curve of Medi1341 [ Time Frame: 13 weeks ]
    - AUC from zero to the last measurable concentration

  4. AUC of Medi1341 from zero to infinity [ Time Frame: 13 weeks ]
    - AUC0-∞

  5. Terminal half-life of Medi1341 [ Time Frame: 13 weeks ]
    - t1/2λz

  6. Clearance of Medi1341 [ Time Frame: 13 weeks ]
    - CL

  7. Volume of distribution of Medi1341 at steady state [ Time Frame: 13 weeks ]
    - Vss

  8. Mean residence time of Medi1341 [ Time Frame: 13 weeks ]
    - MRT

  9. Total alpha-synuclein concentrations [ Time Frame: 13 weeks ]
    - in plasma

  10. Free alpha-synuclein concentrations [ Time Frame: 29 days ]
    - in Cerebrospinal Fluid

  11. Anti-Drug Antibodies to MEDI1341 [ Time Frame: 13 weeks ]
    - in serum

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects must be healthy, with no clinically significant abnormality identified on the medical or laboratory evaluation at screening
  • Subjects must weigh ≥50 kg and must have a body mass index between 18 and 32 kg/m2, inclusive
  • Subjects must have a 12-lead ECG recorded at screening that is normal for the appropriate age group and shows no abnormalities that will compromise safety in this study
  • Subjects must have no clinically significant findings on the clinical neurological examinations at screening and at baseline or on the ophthalmic examination at screening.

Exclusion Criteria:

  • 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
  • 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 subjects, a positive serum or urine pregnancy test result at screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03272165

Layout table for location information
United States, Texas
Research Site
Dallas, Texas, United States, 75247
United States, Wisconsin
Research Site
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
MMS Holdings, Inc
Layout table for investigator information
Principal Investigator: Jeanelle Kam, MD, CPI Covance Dallas CRU, USA
Principal Investigator: John E Blanchard, MD Covance Madison CRU, USA
Layout table for additonal information
Responsible Party: AstraZeneca Identifier: NCT03272165    
Other Study ID Numbers: D6340C00001
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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:
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at
Access Criteria: When a request has been approved, AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsor tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Healthy Volunteers
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases