Pharmacokinetics, Immunogenicity, Safety and Tolerability of MEDI3506 in Health Chinese Participants

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: Placebo; Biological: MEDI3506

• Registration Number: NCT05070312
• Lead Sponsor: AstraZeneca

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

Study Timeline

• Study First Submitted: 2021-07-27
• Study Start: 2021-08-23
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-10-07
• Primary Completion: 2022-02-07
• Study Completion: 2022-02-07
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo 2 mL and 4 mL
MEDI3506 dose 1	MEDI3506	MEDI3506 dose1
MEDI3506 dose 2	MEDI3506	MEDI3506 dose 2

Primary Outcome Measures

Name	Time	Method
Maximum observed concentration (Cmax)	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)	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)	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)	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)	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)	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)	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 Outcome Measures

Name	Time	Method
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 incidence measured as number of participants with positive treatment emergent ADA
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	Immunogenicity prevalence measured as number of participants with ADA positive at baseline and/or post-baseline

Trial Locations

Locations (1)

Research Site; 🇨🇳 Suzhou, China