Research Site
Sumida-ku, 130-0004, Japan
NCT Number: NCT05107336
This Phase I, randomised, single-blind, placebo-controlled study has been designed to assess the safety, tolerability, and pharmacokinetics (PK) of AZD2693 following subcutaneous (SC) administration of AZD2693 in healthy participants
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Notify Me20 year–60 year
All sexes
Interventional
Phase 1
Sumida-ku, 130-0004, Japan
The study will be performed at a single study center in Japan.
The study will comprise of following periods:
Participants will be enrolled in 4 consecutive cohorts of 11 participants where 8 participants will be randomized to receive AZD2693 and 3 participants will be randomized to receive placebo.
A participant is considered to have completed the study if the participant has completed all phases of the study including the last visit.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive subcutaneous injection of AZD2693, once per month.
Participants will receive subcutaneous injection of placebo (volume matching to AZD2693 injection [0.9% saline solution]), once per month.
Time frame: Until Day 162 (Final/Early termination visit)
Safety and tolerability of AZD2693 compared to placebo following multiple dose SC administration in healthy participants will be evaluated.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Cmax of AZD2693 following single dose SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
tmax of AZD2693 following single dose SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
λz of AZD2693 following single and multiple doses SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
t½λz of AZD2693 following single and multiple doses SC administration of AZD2693 in healthy participants will be characterized. The t½λz , estimated as (ln2)/λz
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
AUC(0-48) of AZD2693 following single and multiple doses SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
AUClast of AZD2693 following single and multiple doses SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
AUCinf of AZD2693 following single dose SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
CL/F of AZD2693 following single and multiple dose SC administration of AZD2693 in healthy participants will be characterized. CL/F is calculated as Dose/AUCinf for single dose and for multiple dose it is calculated as Dose/AUCτAUCss.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
MRTinf of AZD2693 following single dose SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
tlag of AZD2693 following single and multiple doses SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Vz/F of AZD2693 following single dose SC administration of AZD2693 in healthy participants will be characterized. Vz/F is estimated by dividing the apparent clearance (CL/F) by λz.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
AUClast/D of AZD2693 following single and multiple doses SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
AUCinf/D of AZD2693 following single dose SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Cmax/D of AZD2693 following single and multiple doses SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
tlast of AZD2693 following single and multiple doses SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Cmax of AZD2693 following multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Cmin of AZD2693 following multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
tmax of AZD2693 following multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
AUCτ of AZD2693 following multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
AUCτ/D of AZD2693 following multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Rac Cmax of AZD2693 following multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Rac AUC of AZD2693 following multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
TCP of AZD2693 following multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose)
(Ae(t1-t2)) of AZD2693 following single and multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose)
Ae(0-last) of AZD2693 following single and multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose)
fe(t1-t2) of AZD2693 following single and multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose)
fe(0-last) of AZD2693 following single and multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Time frame: Day 1 and Day 57 (pre-dose and post-dose)
CLR of AZD2693 following single and multiple dose SC administration of AZD2693 in healthy participants will be characterized.
AstraZeneca
Industry
A Randomised, Single-Blind, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD2693 Following Multiple Subcutaneous Dose Administration in Healthy 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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