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
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
Treatments tested in this trial
- HRS-8797
- Placebo
Treatment groups
74 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov