Health TrialsbyHealthPanel

A Clinical Study of HRS-8797 in Healthy Participants

ConditionAtopic Dermatitis
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorChengdu Suncadia Medicine Co., Ltd.

About this trial

The purpose of this phase I study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-8797 in healthy participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy men and women aged 18 to 55 years old at informed consent signing

Male body weight ≥50 kg , female ≥45 kg; BMI 18 to 28 kg/m² at screening and baseline

Have no clinically significant abnormalities at screening and baseline

Fertile females and males with fertile female partners: effective contraception consent, and sustained until 4 weeks after the last dose (abstinence or highly effective contraception); no sperm/egg donation

Disqualifiers

A history or current severe diseases of multiple systems, or other diseases interfering with trial results.

Severe infection, trauma, major surgery within 3 months before screening; planned surgery during the trial.

Blood donation/severe blood loss (≥400 mL) within 3 months, blood transfusion within 4 weeks before screening; planned blood donation during the trial.

History of drug abuse/dependence; positive urine drug test at screening. Participation in other clinical trials within 3 months before screening or planned

Trial design

Design model

Parallel

Treatments tested in this trial

  • HRS-8797

    Drug

    Specified dose on specified days

  • Placebo

    Drug

    Specified dose on specified days

Treatment groups

74 Participants
are divided into 2 treatment groups
Group A: single ascending dose (SAD) cohortsExperimental treatment 2 interventions
Group B: multiple ascending dose (MAD) cohortsExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety: incidence of adverse event (AE), serious adverse event (SAE)

Time frame
Day1-Day15 (SAD)；Day1-Day15 (FE)；Day1-Day21 (MAD)

Secondary outcomes

1

PK parameter of HRS-8797 : Area under the concentration time curve (AUC)

Time frame
Days 1-19
2

PK parameter of HRS-8797: Maximum Plasma Concentration (Cmax)

Time frame
Days 1-19
3

PK parameter of HRS-8797 : Time to maximum plasma concentration (Tmax)

Time frame
Days 1-19
4

PK parameter of HRS-8797 : Apparent clearance (CL/F)

Time frame
Days 1-19

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chengdu Suncadia Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: