Psoriasis
Conditions
Brief summary
The purpose of this study is to assess safety, PK and immunogenicity profile of a single dose of SHR-1139 in healthy volunteers
Interventions
Single dose of SHR-1139 given subcutaneously (dose level 1 )
Sponsors
Atridia Pty Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy white participants. 2. 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. 3. Male aged between 18 to 55 years of age (inclusive) 4. Women with body weight ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive) at screening. 5. Men and WOCBP must agree to take highly effective contraceptive methods
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 any component of it. 3. Receipt of medical devices or another investigational drug (including placebo) within 3 months or 5 half-lives, or in the follow-up period of a clinical study, whichever is longer (according to the date of the signed consent form) prior to screening. 4. Unwilling or unable to comply with the Lifestyle Guidelines detailed in this protocol. 5. Positive pregnancy test at screening or D-1/check-in. 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 |
|---|---|---|
| PK profile of SHR-1139 after a single administration | Start of Treatment to end of study (Day 253) | Pharmacokinetics- Area under the concentration-time curve from time 0 to last time point after SHR-1139 administration (AUC0-last) |
| PK profile of SHR-1139 after a single administration: | Start of Treatment to end of study (Day 253) | Pharmacokinetics- Time to Cmax of SHR-1139 (Tmax ) |
| Immunogenicity profile of SHR-1139 after a single dose administration | Day 253 | The number of participants with anti-drug antibody (ADA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events | Day 295 | Number of participants with Adverse events and Serious adverse events |
Countries
Australia
Outcome results
None listed