Linear Clinical research
Perth, Western Australia, Australia
NCT Number: NCT06519981
This is a phase 1, randomized, double-blind, placebo-controlled study. The objective of this study is to evaluate the safety, tolerability, and PK profile of HRS-9231 injection following a single dose in healthy Caucasian participants.
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Notify Me18 year–45 year
All sexes
Interventional
Early Phase 1
Perth, Western Australia, Australia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
HRS-9231 injection or matching placebo will be administered through IV injection.
Time frame: Day 8
Number of patients with adverse events (AEs) and serious adverse event (SAE)
Time frame: Day 8
Number of patients with clinically significant change from baseline in vital signs values
Time frame: Day 8
Number of patients with clinically significant change in physical examination
Time frame: Day 8
Number of patients with clinically significant change from baseline in laboratory examination
Time frame: Day 8
Number of patients with clinically significant change from baseline in 12-ECG values
Time frame: Day 8
Number of patients with injection site reaction
Time frame: Day 1
Plasma Pharmacokinetics: Cmax
Time frame: Day 1
Plasma Pharmacokinetics: AUC0-t
Time frame: Day 1
Plasma Pharmacokinetics: AUC0-inf
Time frame: Day 1
Plasma Pharmacokinetics: Tmax
Time frame: Day 1
Plasma Pharmacokinetics: t1/2
Time frame: Day 1
Plasma Pharmacokinetics: CL
Time frame: Day 1
Plasma Pharmacokinetics: Vz
Time frame: Day 1
Plasma Pharmacokinetics: MRTlast
Time frame: Day 1
Plasma Pharmacokinetics: MRTinf
Time frame: Day 3
Urine Pharmacokinetics: Ae
Time frame: Day 3
Urine Pharmacokinetics: ur
Time frame: Day 3
Urine Pharmacokinetics: %Ae
Time frame: Day 3
Urine Pharmacokinetics: CLr
Atridia Pty Ltd.
Industry
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-9231 in Healthy Caucasian 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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