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Completed

NCT Number: NCT06519981

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

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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Key information

Conditions

MRI

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Linear Clinical research

Perth, Western Australia, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HRS-9231or matching placebo

Drug

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

Primary outcomes

  1. Adverse events

    Time frame: Day 8

    Number of patients with adverse events (AEs) and serious adverse event (SAE)

  2. Vital signs

    Time frame: Day 8

    Number of patients with clinically significant change from baseline in vital signs values

  3. Physical examination

    Time frame: Day 8

    Number of patients with clinically significant change in physical examination

  4. Laboratory

    Time frame: Day 8

    Number of patients with clinically significant change from baseline in laboratory examination

  5. ECG

    Time frame: Day 8

    Number of patients with clinically significant change from baseline in 12-ECG values

  6. Injection site reaction

    Time frame: Day 8

    Number of patients with injection site reaction

Secondary outcomes

  1. Pharmacokinetics PK Cmax

    Time frame: Day 1

    Plasma Pharmacokinetics: Cmax

  2. Pharmacokinetics PK AUC0-t

    Time frame: Day 1

    Plasma Pharmacokinetics: AUC0-t

  3. Pharmacokinetics PK AUC0-inf

    Time frame: Day 1

    Plasma Pharmacokinetics: AUC0-inf

  4. Pharmacokinetics PK Tmax

    Time frame: Day 1

    Plasma Pharmacokinetics: Tmax

  5. Pharmacokinetics PK t1/2

    Time frame: Day 1

    Plasma Pharmacokinetics: t1/2

  6. Pharmacokinetics PK CL

    Time frame: Day 1

    Plasma Pharmacokinetics: CL

  7. Pharmacokinetics PK Vz

    Time frame: Day 1

    Plasma Pharmacokinetics: Vz

  8. Pharmacokinetics PK MRTlast

    Time frame: Day 1

    Plasma Pharmacokinetics: MRTlast

  9. Pharmacokinetics PK MRTinf

    Time frame: Day 1

    Plasma Pharmacokinetics: MRTinf

  10. Pharmacokinetics PK Ae

    Time frame: Day 3

    Urine Pharmacokinetics: Ae

  11. Pharmacokinetics PK ur

    Time frame: Day 3

    Urine Pharmacokinetics: ur

  12. Pharmacokinetics PK %Ae

    Time frame: Day 3

    Urine Pharmacokinetics: %Ae

  13. Pharmacokinetics PK CLr

    Time frame: Day 3

    Urine Pharmacokinetics: CLr

Sponsors and collaborators

Lead sponsor

Atridia Pty Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 25, 2024
Registry last updated
Dec 6, 2024

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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