CompletedNCT06519981Updated Dec 6, 2024

Phase 1 Study of HRS-9231 Safety and Pharmacokinetics in Healthy Caucasians

An Early Phase 1 interventional study of HRS-9231or matching placebo in MRI, sponsored by Atridia Pty Ltd.. Completed at 1 site in Australia. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-06.

Sponsored by Atridia Pty Ltd. · Early Phase 1, Interventional, and Diagnostic

Phase: Early Phase 1
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 18 Years to 45 Years
Sex: All

Study summary

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.

Conditions studied

In context

Lead sponsor

Atridia Pty Ltd. is the lead sponsor of 34 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy Caucasian participants;
Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
Male or female aged between 18 to 45 years of age (inclusive) at the date of signed consent form.
Women with body weight of ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass Index (BMI) between 18.0 and 32.0 kg/m2

Exclusion criteria

Exclusion Criteria:

History or evidence of clinically significant disorders
Individuals with a history of drug allergies, specific allergies
Severe infections, injuries, or major surgeries as determined by the investigator within 3 months prior to dosing, or plan to do surgeries during the study.
Any other circumstances (e.g., not suitable for venous access) or laboratory
abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the Study or could preclude the evaluation of the participant's response.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study design

Phase: Early Phase 1
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 20 participants (actual)

Study arms

Experimental
HRS-9231 or matching placebo Dose level 1
Dose level 1
Drug: HRS-9231or matching placebo
Experimental
HRS-9231 or matching placebo Dose level 2
Drug: HRS-9231or matching placebo

Interventions

DrugHRS-9231or matching placebo
HRS-9231 injection or matching placebo will be administered through IV injection.

What researchers measure

Primary outcomes

Adverse events
Number of patients with adverse events (AEs) and serious adverse event (SAE)
Time frame: Day 8
Vital signs
Number of patients with clinically significant change from baseline in vital signs values
Time frame: Day 8
Physical examination
Number of patients with clinically significant change in physical examination
Time frame: Day 8
Laboratory
Number of patients with clinically significant change from baseline in laboratory examination
Time frame: Day 8
ECG
Number of patients with clinically significant change from baseline in 12-ECG values
Time frame: Day 8
Injection site reaction
Number of patients with injection site reaction
Time frame: Day 8

Secondary outcomes

Pharmacokinetics PK Cmax
Plasma Pharmacokinetics: Cmax
Time frame: Day 1
Pharmacokinetics PK AUC0-t
Plasma Pharmacokinetics: AUC0-t
Time frame: Day 1
Pharmacokinetics PK AUC0-inf
Plasma Pharmacokinetics: AUC0-inf
Time frame: Day 1
Pharmacokinetics PK Tmax
Plasma Pharmacokinetics: Tmax
Time frame: Day 1
Pharmacokinetics PK t1/2
Plasma Pharmacokinetics: t1/2
Time frame: Day 1
Pharmacokinetics PK CL
Plasma Pharmacokinetics: CL
Time frame: Day 1
Pharmacokinetics PK Vz
Plasma Pharmacokinetics: Vz
Time frame: Day 1
Pharmacokinetics PK MRTlast
Plasma Pharmacokinetics: MRTlast
Time frame: Day 1
Pharmacokinetics PK MRTinf
Plasma Pharmacokinetics: MRTinf
Time frame: Day 1
Pharmacokinetics PK Ae
Urine Pharmacokinetics: Ae
Time frame: Day 3
Pharmacokinetics PK ur
Urine Pharmacokinetics: ur
Time frame: Day 3
Pharmacokinetics PK %Ae
Urine Pharmacokinetics: %Ae
Time frame: Day 3
Pharmacokinetics PK CLr
Urine Pharmacokinetics: CLr
Time frame: Day 3

Study locations

1 site

Linear Clinical research
Perth, Western Australia, Australia

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06519981
Lead sponsor: Atridia Pty Ltd.
Responsible party: Sponsor
First posted: Jul 25, 2024
Start date: Aug 21, 2024
Primary completion: Sep 29, 2024
Completion: Nov 27, 2024
Last update: Dec 6, 2024

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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