Research Site
Sumida-ku, 130-0004, Japan
NCT Number: NCT06093542
The study will evaluate the safety, tolerability, and the pharmacokinetics (PK) of AZD7503 following multiple subcutaneous doses in healthy Japanese participants.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Sumida-ku, 130-0004, Japan
This is a Phase I, randomised, single-blind, placebo-controlled study. The healthy Japanese participants will receive randomly (3:1) either AZD7503 or placebo subcutaneously.
The study will comprise of:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Randomised participants will receive AZD7503 subcutaneously.
Randomised participants will receive placebo subcutaneously.
Time frame: From Screening (Day -28) until Follow-up Day 127 (10 weeks post last dose)
The safety and tolerability after multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Time frame: Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
The Cmax after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Time frame: Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
The AUClast after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Time frame: Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
The AUCinf after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Time frame: Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
The AUCtau after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Time frame: Day 1, Day 2, Day 3, Day 58, and Day 59
The Ae after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Time frame: Day 1, Day 2, Day 3, Day 58, and Day 59
The Fe after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Time frame: Day 1, Day 2, Day 3, Day 58, and Day 59
The plasma concentration after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Time frame: Day 1, Day 2, Day 3, Day 58, and Day 59
The plasma concentration of unconjugated ASO at specified timepoints after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
AstraZeneca
Industry
A Randomised, Single-blind, Single Center, Placebo-controlled, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7503 Following Multiple Subcutaneous Dose Administration in Healthy Japanese Participants.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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