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
Overview
- Phase
- Early Phase 1
- Intervention
- HRS-9231or matching placebo
- Conditions
- MRI
- Sponsor
- Atridia Pty Ltd.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Physical examination
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
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
- •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
Arms & Interventions
HRS-9231 or matching placebo Dose level 1
Dose level 1
Intervention: HRS-9231or matching placebo
HRS-9231 or matching placebo Dose level 2
Intervention: HRS-9231or matching placebo
Outcomes
Primary Outcomes
Physical examination
Time Frame: Day 8
Number of patients with clinically significant change in physical examination
ECG
Time Frame: Day 8
Number of patients with clinically significant change from baseline in 12-ECG values
Injection site reaction
Time Frame: Day 8
Number of patients with injection site reaction
Adverse events
Time Frame: Day 8
Number of patients with adverse events (AEs) and serious adverse event (SAE)
Vital signs
Time Frame: Day 8
Number of patients with clinically significant change from baseline in vital signs values
Laboratory
Time Frame: Day 8
Number of patients with clinically significant change from baseline in laboratory examination
Secondary Outcomes
- Pharmacokinetics PK MRTlast(Day 1)
- Pharmacokinetics PK t1/2(Day 1)
- Pharmacokinetics PK %Ae(Day 3)
- Pharmacokinetics PK ur(Day 3)
- Pharmacokinetics PK Cmax(Day 1)
- Pharmacokinetics PK AUC0-t(Day 1)
- Pharmacokinetics PK AUC0-inf(Day 1)
- Pharmacokinetics PK Tmax(Day 1)
- Pharmacokinetics PK CL(Day 1)
- Pharmacokinetics PK Vz(Day 1)
- Pharmacokinetics PK MRTinf(Day 1)
- Pharmacokinetics PK Ae(Day 3)
- Pharmacokinetics PK CLr(Day 3)