A Study of the Safety, Tolerability and Pharmacokinetics of MEDI0618 in Healthy Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Pain
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Investigator)Masking Description: Double-blindPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Both males and females
Description
This is 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. This study will include 9 planned cohorts; 8 cohorts will receive single ascending doses of MEDI0618 or placebo b...
This is 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. This study will include 9 planned cohorts; 8 cohorts will receive single ascending doses of MEDI0618 or placebo by intravenous administration, 1 cohort will receive MEDI0618 or placebo by subcutaneous administration.All subjects will undergo scheduled safety, tolerability, pharmacokinetic and immunogenicity assessments while in the clinical unit and as outpatients to the end of the follow-up period.
Tracking Information
- NCT #
- NCT04198558
- Collaborators
- Not Provided
- Investigators
- Study Director: Tharani Chessell, PhD AstraZeneca Principal Investigator: Stanislav Ignatenko, Medical Doctor Charite Research Organisation
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