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 : August 7, 2020
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|
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.
|Study Type :||Interventional|
|Estimated Enrollment :||48 participants|
|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)|
|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 :||January 19, 2021|
|Estimated Study Completion Date :||January 19, 2021|
Intravenous infusion over 60 minutes
|Placebo Comparator: Placebo||
Intravenous infusion over 60 minutes
- Adverse Events [ Time Frame: 13 weeks ]- Incidence, nature, severity and seriousness
- Vital Signs [ Time Frame: 13 weeks ]- Blood pressure and pulse rate
- Oral Body Temperature [ Time Frame: 13 weeks ]- in Celsius
- Body weight [ Time Frame: 13 weeks ]- in kilograms
- Height [ Time Frame: 13 weeks ]- in meters
- Body Mass Index (BMI) [ Time Frame: 13 weeks ]- Weight and height will be combined to report BMI in kg/m2
- Safety Laboratory tests [ Time Frame: 13 weeks ]- Clinical chemistry, hematology, coagulation, urinalysis
- 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)
- Ophthalmic assessments [ Time Frame: 13 weeks ]
- a standardized ophthalmic patient-reported outcome questionnaire
- visual acuity
- intraocular pressure
- corneal thickness
- slit-lamp examination
- optical coherence tomography
- visual field assessment
- Maximum concentration of Medi1341 [ Time Frame: 13 weeks ]- Cmax
- Time to maximum concentration of Medi1341 [ Time Frame: 13 weeks ]- tmax
- Area under the concentration - time curve of Medi1341 [ Time Frame: 13 weeks ]- AUC from zero to the last measurable concentration
- AUC of Medi1341 from zero to infinity [ Time Frame: 13 weeks ]- AUC0-∞
- Terminal half-life of Medi1341 [ Time Frame: 13 weeks ]- t1/2λz
- Clearance of Medi1341 [ Time Frame: 13 weeks ]- CL
- Volume of distribution of Medi1341 at steady state [ Time Frame: 13 weeks ]- Vss
- Mean residence time of Medi1341 [ Time Frame: 13 weeks ]- MRT
- Total alpha-synuclein concentrations [ Time Frame: 13 weeks ]- in plasma
- Free alpha-synuclein concentrations [ Time Frame: 29 days ]- in Cerebrospinal Fluid
- Anti-Drug Antibodies to MEDI1341 [ Time Frame: 13 weeks ]- in serum
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
|Contact: AstraZeneca Clinical Study Information Centeremail@example.com|
|United States, Texas|
|Dallas, Texas, United States, 75247|
|United States, Wisconsin|
|Madison, Wisconsin, United States, 53704|
|Leeds, United Kingdom, LS2 9LH|
|Principal Investigator:||Jeanelle Kam, MD, CPI||Covance Dallas CRU, USA|
|Principal Investigator:||John E Blanchard, MD||Covance Madison CRU, USA|