Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HRS-3095

    Drug

    Single dose HRS-3095 /placebo given orally - Dose level 1

  • HRS-3095

    Drug

    Single dose HRS-3095 /placebo given orally - Dose level 2

  • HRS-3095

    Drug

    Single dose HRS-3095 /placebo given orally - Dose level 3

Treatment groups

36 Participants
are divided into 3 treatment groups
Group A: HRS-3095 single dose Dose level 1Experimental treatment 1 intervention
Group B: HRS-3095 single dose Dose level 2Experimental treatment 1 intervention
Group C: HRS-3095 single dose Dose level 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events

Number of participants with Adverse events and Serious adverse events

Time frame
Day 8

Secondary outcomes

1

PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - Cmax

Maximum observed plasma concentration (Cmax)

Time frame
Day 4
2

PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - AU0-inf

Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC₀0-inf)

Time frame
Day 4
3

PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - Tmax

Time to reach maximum observed plasma concentration (Tmax)

Time frame
Day 4
4

PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - t½

Terminal elimination half-life (t1/2)

Time frame
Day 4

Other outcomes

Sponsors and contacts

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

Atridia Pty Ltd.

Lead sponsor

Source ClinicalTrials.gov
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