Research Site
Baltimore, Maryland, 21225, United States
NCT Number: NCT06311760
This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD0292 following intravenous (IV) administration of single ascending doses to healthy adult participants.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Baltimore, Maryland, 21225, United States
This is a First-time-in-human (FTiH) trial.
Eligible participants will be randomized to receive AZD0292 or Placebo. Participants will receive pre-medication with an antihistamine prior to dosing with the study intervention.
The study will comprise:
Participants will be involved in this study for a maximum duration of 13 weeks.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
AZD0292 will be administered as single dose via IV infusion.
Placebo will be administered as IV infusion.
Time frame: Up to 13 weeks
The safety and tolerability of AZD0292 following IV administration of single ascending doses to healthy adult participants will be assessed.
Time frame: Up to 13 weeks
The safety and tolerability of AZD0292 following IV administration of single ascending doses to healthy adult participants will be assessed.
Time frame: From Dosing (Day 1) to end of the study (up to 13 weeks)
The PK (Cmax) of AZD0292 following IV administration of single ascending doses of AZD0292 to healthy adult participants will be assessed.
Time frame: From Dosing (Day 1) to end of the study (up to 13 weeks)
The PK (AUClast) of AZD0292 following IV administration of single ascending doses of AZD0292 to healthy adult participants will be assessed.
Time frame: From Dosing (Day 1) to end of the study (up to 13 weeks)
The PK (AUCinfinity) of AZD0292 following IV administration of single ascending doses of AZD0292 to healthy adult participants will be assessed.
Time frame: From Dosing (Day 1) to end of the study (up to 13 weeks)
The ADA responses following IV administration of single ascending doses of AZD0292 to healthy adult participants will be evaluated.
AstraZeneca
Industry
A Phase I, Randomized, Single-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, And Pharmacokinetics of AZD0292 Following Single Ascending Dose Administration to 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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