A Trial of HRS-3095 in Healthy Volunteers
ConditionChronic Spontaneous Urticaria
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAtridia Pty Ltd.
About this trial
The purpose of this study is to assess safety, PK, Pharmacodynamic profile of a single dose of HRS-3095 in healthy participants
Eligibility criteria
Qualifiers
Male or female aged between 18 years and 55 years (inclusive)
Ability to understand the trial procedures and possible adverse events, volunteer to participate in the trial, and provide written informed consent, be able to comply with all the requirements, and able to complete the study.
Women with body weight ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass index (BMI) between 19.0 and 30.0 kg/m2 (inclusive) at screening.
Men and WOCBP must agree to take highly effective contraceptive methods
Disqualifiers
History or evidence of clinically significant disorders.
Individuals with a history of drug allergies, specific allergies, or known history or suspected of being allergic to the study drug or same class drug or any component of it.
Receipt of medical devices or another investigational drug within 3 months or 5 half-lives, whichever is longer prior to screening.
History of excessive smoking in the past 1 month prior to screening
Trial design
Treatments tested in this trial
- HRS-3095
- HRS-3095
- HRS-3095
Treatment groups
36 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov