A Phase I, Randomized, Double-blind, Placebo-controlled, Dose-ascending Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of MEDI3506 in Healthy Chinese Participants
Overview
- Phase
- Phase 1
- Intervention
- MEDI3506
- Conditions
- Healthy Volunteer
- Sponsor
- AstraZeneca
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Maximum observed concentration (Cmax)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study is to evaluate the pharmacokinetics, immunogenicity, safety and tolerability of investigational drug MEDI3506 with single dose in Healthy Chinese participants.
Detailed Description
A phase I, randomised, double-blind, placebo-controlled parallel-group study to evaluate the pharmacokinetics, immunogenicity, safety, and tolerability of single dose of MEDI3506 in healthy Chinese Participants
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
MEDI3506 dose 1
MEDI3506 dose1
Intervention: MEDI3506
MEDI3506 dose 2
MEDI3506 dose 2
Intervention: MEDI3506
Placebo
Placebo 2 mL and 4 mL
Intervention: Placebo
Outcomes
Primary Outcomes
Maximum observed concentration (Cmax)
Time Frame: Day 1 to Day 113
To assess the maximum plasma concentration of MEDI3506 after single subcutaneous administrations in healthy Chinese participants.
Time to reach maximum observed concentration (tmax)
Time Frame: Day 1 to Day 113
To assess the MEDI3506 time to reach peak serum concentration after single subcutaneous administration of MEDI3506 in healthy Chinese participants.
Area under the serum concentration time curve to the last observation(AUC0-t)
Time Frame: Day 1 to Day 113
To assess the area under the serum concentration time curve from pre-dose until the last observation quantified after single Subcutaneous administration of MEDI3506 in healthy Chinese participants
Apparent volume of distribution based on terminal phase (Vz/F)
Time Frame: Day 1 to Day 113
To assess the apparent volume of distribution of MEDI3506 after single subcutaneous administration of MEDI3506 in healthy Chinese participants
Area under the serum concentration time curve to the infinite (AUC0-inf)
Time Frame: Day 1 to Day 113
To assess the area under the serum concentration time curve from pre-dose until infinite after single Subcutaneous administration of MEDI3506 in healthy Chinese participants
Terminal Elimination half-life (t1/2)
Time Frame: Day 1 to Day 113
To assess the terminal elimination half-life after single Subcutaneous administration of MEDI3506 in healthy Chinese participants
Apparent total body Clearance (CL/F)
Time Frame: Day 1 to Day 113
To evaluate the apparent MEDI3506 total body clearance from serum after single subcutaneous administration of MEDI3506 in healthy Chinese participants
Secondary Outcomes
- Immunogenicity determined by incidence of ADA(Day 1 (-30~0 min before IP administration), and on Day 8, Day 29, Day 57, Day 85 and Day 113)
- Immunogenicity determined by prevalence of antidrug antibodies (ADA)(Day 1 (-30~0 min before IP administration), and on Day 8, Day 29, Day 57, Day 85 and Day 113)