Clinical trial NCT06519981: Phase 1 Study of HRS-9231 Safety and Pharmacokinetics in Healthy Caucasians
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: MRI
Lead sponsor: Atridia Pty Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Healthy participants are planned to be enrolled in a single ascending dose study. For each cohort, participants will randomly receive HRS-9231/Placebo injection by an intravenous (IV) administration
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

1. Healthy Caucasian participants;
2. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
3. Male or female aged between 18 to 45 years of age (inclusive) at the date of signed consent form.
4. 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:

1. History or evidence of clinically significant disorders
2. Individuals with a history of drug allergies, specific allergies
3. 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.
4. Any other circumstances (e.g., not suitable for venous access) or laboratory
5. 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

Primary outcomes:
measure: Adverse events
timeFrame: Day 8
measure: Vital signs
timeFrame: Day 8
measure: Physical examination
timeFrame: Day 8
measure: Laboratory
timeFrame: Day 8
measure: ECG
timeFrame: Day 8
measure: Injection site reaction
timeFrame: Day 8
Secondary outcomes:
measure: Pharmacokinetics PK Cmax
timeFrame: Day 1
measure: Pharmacokinetics PK AUC0-t
timeFrame: Day 1
measure: Pharmacokinetics PK AUC0-inf
timeFrame: Day 1
measure: Pharmacokinetics PK Tmax
timeFrame: Day 1
measure: Pharmacokinetics PK t1/2
timeFrame: Day 1
measure: Pharmacokinetics PK CL
timeFrame: Day 1
measure: Pharmacokinetics PK Vz
timeFrame: Day 1
measure: Pharmacokinetics PK MRTlast
timeFrame: Day 1
measure: Pharmacokinetics PK MRTinf
timeFrame: Day 1
measure: Pharmacokinetics PK Ae
timeFrame: Day 3
measure: Pharmacokinetics PK ur
timeFrame: Day 3
measure: Pharmacokinetics PK %Ae
timeFrame: Day 3
measure: Pharmacokinetics PK CLr
timeFrame: Day 3
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Linear Clinical research
state: Western Australia
Study officials:
References: