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
64
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 2023 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Cohort 9: MEDI0618 Dose Level 9 Participants will receive a single SC injection of MEDI0618 Dose level 9 on Day 1. | Drug: MEDI0618 Participants will receive multiple dose levels of MEDI0618 on Day 1 as stated in arm description. |
| Placebo Comparator: Cohort 9: Placebo Participants will receive a single SC injection of placebo matched to MEDI0618 Dose level 9 on Day 1. | Drug: Placebo Participants will receive placebo matched to MEDI0618 on Day 1 as stated in arm description. |
| Experimental: Cohort 8: MEDI0618 Dose Level 8 Participants will receive a single IV infusion of MEDI0618 Dose level 8 on Day 1. | Drug: MEDI0618 Participants will receive multiple dose levels of MEDI0618 on Day 1 as stated in arm description. |
| Experimental: Cohort 7: MEDI0618 Dose Level 7 Participants will receive a single IV infusion of MEDI0618 Dose level 7 on Day 1. | Drug: MEDI0618 Participants will receive multiple dose levels of MEDI0618 on Day 1 as stated in arm description. |
| Experimental: Cohort 6: MEDI0618 Dose Level 6 Participants will receive a single IV infusion of MEDI0618 Dose level 6 on Day 1. | Drug: MEDI0618 Participants will receive multiple dose levels of MEDI0618 on Day 1 as stated in arm description. |
| Experimental: Cohort 5: MEDI0618 Dose Level 5 Participants will receive a single IV infusion of MEDI0618 Dose level 5 on Day 1. | Drug: MEDI0618 Participants will receive multiple dose levels of MEDI0618 on Day 1 as stated in arm description. |
| Experimental: Cohort 4: MEDI0618 Dose Level 4 Participants will receive a single IV infusion of MEDI0618 Dose level 4 on Day 1. | Drug: MEDI0618 Participants will receive multiple dose levels of MEDI0618 on Day 1 as stated in arm description. |
| Experimental: Cohort 3: MEDI0618 Dose Level 3 Participants will receive a single IV infusion of MEDI0618 Dose level 3 on Day 1. | Drug: MEDI0618 Participants will receive multiple dose levels of MEDI0618 on Day 1 as stated in arm description. |
| Experimental: Cohort 2: MEDI0618 Dose Level 2 Participants will receive a single IV infusion of MEDI0618 Dose level 2 on Day 1. | Drug: MEDI0618 Participants will receive multiple dose levels of MEDI0618 on Day 1 as stated in arm description. |
| Experimental: Cohort 1: MEDI0618 Dose Level 1 Participants will receive a single IV infusion of MEDI0618 Dose level 1 on Day 1. | Drug: MEDI0618 Participants will receive multiple dose levels of MEDI0618 on Day 1 as stated in arm description. |
| Placebo Comparator: Cohorts 1-8: Placebo Participants will receive a single dose of placebo matched to MEDI0618 Dose levels 1-8 by IV infusion on Day 1. | Drug: Placebo Participants will receive placebo matched to MEDI0618 on Day 1 as stated in arm description. |
Contacts
Investigators
Principal Investigator
Tharani Chessell
AstraZeneca
