Chronic Spontaneous Urticaria
Conditions
Brief summary
The purpose of this study is to assess safety, PK, Pharmacodynamic profile of a single dose of HRS-3095 in healthy participants
Interventions
DRUGHRS-3095
Single dose HRS-3095 /placebo given orally - Dose level 1
Sponsors
Atridia Pty Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
HRS-3095 or matching placebo given orally
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Main inclusion criteria 1. Healthy white participants. 2. Male or female aged between 18 years and 55 years (inclusive) 3. 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. 4. 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. 5. Men and WOCBP must agree to take highly effective contraceptive methods Main
Exclusion criteria
1. History or evidence of clinically significant disorders. 2. 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. 3. Receipt of medical devices or another investigational drug within 3 months or 5 half-lives, whichever is longer prior to screening. 4. History of excessive smoking in the past 1 month prior to screening 5. History of illicit or prescription drug abuse or addiction within 1 year of screening, or positive urine drug screen at baseline. 6. 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events | Day 8 | Number of participants with Adverse events and Serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - Cmax | Day 4 | Maximum observed plasma concentration (Cmax) |
| PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - AU0-inf | Day 4 | Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC₀0-inf) |
| PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - Tmax | Day 4 | Time to reach maximum observed plasma concentration (Tmax) |
| PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - t½ | Day 4 | Terminal elimination half-life (t1/2) |
| PD Profile of HRS-3095 After a Single dose administration: | Day 8 | Target occupancy assessment |
Countries
Australia
Contacts
CONTACTKathy You
CONTACTEimy Minowa
Outcome results
None listed