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Single Ascending Dose Study of MEDI1341 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT03272165
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : February 15, 2019
Sponsor:
Collaborators:
Covance
MMS Holdings, Inc
Catalent
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:

This is a single-centre study of single ascending intravenous doses of MEDI1341 or placebo in up to 48 healthy volunteers, aged 18 to 80 years.

The study will include up to 5 planned cohorts; each cohort will comprise 8 subjects. An optional sixth cohort of 8 subjects may be studied.

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 single-center, randomized, double-blind, placebo-controlled study of single ascending intravenous doses of MEDI1341 in male and nonfertile female healthy volunteers, aged 18 to 80 years.

The study will include up to 5 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. An optional sixth cohort of 8 subjects may be studied, based on an interim review of safety, tolerability, and pharmacokinetic/ pharmacodynamic data, with a dose level that may be lower than, the same as, or higher than for any preceding cohort.

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Primary Completion Date : November 6, 2019
Estimated Study Completion Date : November 6, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MEDI1341 Drug: MEDI1341
Intravenous infusion over 60 minutes

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)


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

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

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 clinical neurological examinations with normal findings at screening and at baseline

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 neurological illness
  • 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 ClinicalTrials.gov identifier (NCT number): NCT03272165


Contacts
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
United States, Texas
Research Site Recruiting
Dallas, Texas, United States, 75247
Sponsors and Collaborators
AstraZeneca
Covance
MMS Holdings, Inc
Catalent
Investigators
Principal Investigator: Jennifer Zon Covance Dallas Clinical Research Unit

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03272165     History of Changes
Other Study ID Numbers: D6340C00001
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AstraZeneca:
Healthy Volunteers
Safety
Tolerability
Pharmacokinetics
Pharmacodynamics
Immunogenicity

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases