A Study of the Safety, Tolerability and Pharmacokinetics of MEDI0618 in Healthy Volunteers
Study identifier:D7060C00001
ClinicalTrials.gov identifier:NCT04198558
EudraCT identifier:2019-002128-33
CTIS identifier:N/A
Study Complete
Official Title
A Randomised, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of MEDI0618 in Healthy Male and Female Volunteers
Medical condition
Chronic Pain
Phase
Phase 1
Healthy volunteers
Yes
Study drug
MEDI0618, Placebo
Sex
All
Actual Enrollment
56
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 29 Nov 2019
Primary Completion Date: 23 Feb 2022
Study Completion Date: 23 Feb 2022
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Mar 2022 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Dose Level 1 MEDI0618 or placebo | Drug: MEDI0618 MEDI0618 A novel human immunoglobulin antibody Drug: Placebo Placebo |
| Experimental: Dose Level 2 MEDI0618 or placebo | Drug: MEDI0618 MEDI0618 A novel human immunoglobulin antibody Drug: Placebo Placebo |
| Experimental: Dose Level 3 MEDI0618 or placebo | Drug: MEDI0618 MEDI0618 A novel human immunoglobulin antibody Drug: Placebo Placebo |
| Experimental: Dose Level 4 MEDI0618 or placebo | Drug: MEDI0618 MEDI0618 A novel human immunoglobulin antibody Drug: Placebo Placebo |
| Experimental: Dose Level 5 MEDI0618 or placebo | Drug: MEDI0618 MEDI0618 A novel human immunoglobulin antibody Drug: Placebo Placebo |
| Experimental: Dose Level 6 MEDI0618 or placebo | Drug: MEDI0618 MEDI0618 A novel human immunoglobulin antibody Drug: Placebo Placebo |
| Experimental: Dose Level 7 MEDI0618 or placebo | Drug: MEDI0618 MEDI0618 A novel human immunoglobulin antibody Drug: Placebo Placebo |
| Experimental: Dose Level 8 MEDI0618 or placebo | Drug: MEDI0618 MEDI0618 A novel human immunoglobulin antibody Drug: Placebo Placebo |
| Experimental: Dose Level 9 MEDI0618 or placebo | Drug: MEDI0618 MEDI0618 A novel human immunoglobulin antibody Drug: Placebo Placebo |
Contacts
Investigators
Principal Investigator
Tharani Chessell
AstraZeneca
