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, MEDI0618, MEDI0618, MEDI0618, MEDI0618, MEDI0618, MEDI0618, MEDI0618, MEDI0618, Placebo, Placebo, Placebo, Placebo, Placebo, Placebo, Placebo, Placebo, 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
Loading...
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
