A Trial of HRS-3095 in Healthy Volunteers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HRS-3095, HRS-3095, HRS-3095.
- Who it may be relevant to
- Registry conditions: Chronic Spontaneous Urticaria. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of HRS-3095 in Healthy Participants
Overview
The purpose of this study is to assess safety, PK, Pharmacodynamic profile of a single dose of HRS-3095 in healthy participants
Interventions
- Drug HRS-3095
Single dose HRS-3095 /placebo given orally - Dose level 1 - Drug HRS-3095
Single dose HRS-3095 /placebo given orally - Dose level 2 - Drug HRS-3095
Single dose HRS-3095 /placebo given orally - Dose level 3
Primary outcome measures
- Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events [Time frame: Day 8]
Secondary outcome measures (5)
- PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - Cmax [Time frame: Day 4]
- PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - AU0-inf [Time frame: Day 4]
- PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - Tmax [Time frame: Day 4]
- PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - t½ [Time frame: Day 4]
- PD Profile of HRS-3095 After a Single dose administration: [Time frame: Day 8]
Eligibility criteria
Main inclusion criteria
- Healthy white participants.
- 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
Main exclusion Criteria
- 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
- History of illicit or prescription drug abuse or addiction within 1 year of screening, or positive urine drug screen at baseline.
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Australia · 1 center
- Veritus Research — Bayswater
Identifiers
NCT: NCT07686484 · HRS-3095-102