Single Ascending Dose Study of MEDI1341 in Healthy Volunteers
Study identifier:D6340C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Parkinson's disease
Phase
Phase 1
Healthy volunteers
Yes
Study drug
MEDI1341, Placebo
Sex
All
Actual Enrollment
50
Study type
Interventional
Age
18 Years - 80 Years
Date
Study Start Date: 17 Oct 2017
Primary Completion Date: 31 Mar 2021
Study Completion Date: 31 Mar 2021
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Covance, Inc, MMS Holdings, Inc, Catalent Pharma Solutions, Takeda Pharmaceutical Company Ltd
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo Participants will receive a single intravenous (IV) infusion of placebo matched to MEDI1341 and will be followed up for 13 weeks. | Drug: Placebo Participants will receive IV infusion of placebo matched to MEDI1341. |
| Experimental: Cohort 1: MEDI1341 Dose 1 Participants will receive a single IV infusion of MEDI1341 Dose 1 and will be followed up for 13 weeks. | Drug: MEDI1341 Participants will receive IV infusion of MEDI1341 doses as stated in the arms' description. Other Name: TAK-341 |
| Experimental: Cohort 2: MEDI1341 Dose 2 Participants will receive a single IV infusion of MEDI1341 Dose 2 and will be followed up for 13 weeks. | Drug: MEDI1341 Participants will receive IV infusion of MEDI1341 doses as stated in the arms' description. Other Name: TAK-341 |
| Experimental: Cohort 3: MEDI1341 Dose 3 Participants will receive a single IV infusion of MEDI1341 Dose 3 and will be followed up for 13 weeks. | Drug: MEDI1341 Participants will receive IV infusion of MEDI1341 doses as stated in the arms' description. Other Name: TAK-341 |
| Experimental: Cohort 4: MEDI1341 Dose 4 Participants will receive a single IV infusion of MEDI1341 Dose 4 and will be followed up for 13 weeks. | Drug: MEDI1341 Participants will receive IV infusion of MEDI1341 doses as stated in the arms' description. Other Name: TAK-341 |
| Experimental: Cohort 5: MEDI1341 Dose 5 Participants will receive a single IV infusion of MEDI1341 Dose 5 and will be followed up for 13 weeks. | Drug: MEDI1341 Participants will receive IV infusion of MEDI1341 doses as stated in the arms' description. Other Name: TAK-341 |
| Experimental: Cohort 6: MEDI1341 Dose 6 Participants will receive a single IV infusion of MEDI1341 Dose 6 and will be followed up for 13 weeks. | Drug: MEDI1341 Participants will receive IV infusion of MEDI1341 doses as stated in the arms' description. Other Name: TAK-341 |
Contacts
Investigators
Principal Investigator
Jeanelle Kam
Covance Dallas CRU, USA
