Immunology
Conditions
Brief summary
The purpose of this study is to assess safety, PK, Pharmacodynamic and immunogenicity profile of a single dose of SHR-2173 in healthy participants
Interventions
DRUGSHR-2173 Injection/SHR-2173 placebo
Single dose SHR-2173 injection or matching placebo given subcutaneously
Sponsors
Atridia Pty Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Single dose of SHR-2173 will be administered subcutaneously
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Main 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 45 years of age (inclusive) 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 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. The injection site has abnormalities or is deemed by the investigator as unsuitable for subcutaneous injection. 5. History of excessive smoking in the past 1 month prior to screening 6. History of illicit or prescription drug abuse or addiction within 1 year of screening, or positive urine drug screen at baseline. 7. 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 |
|---|---|---|
| Pharmacokinetics - Cmax | Day 71 | Maximum observed plasma concentration (Cmax) |
| Pharmacokinetics - AUC₀-t | Day 71 | Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC₀-t) |
| Pharmacokinetics - AUC₀-inf | Day 71 | Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC₀-inf) |
| Pharmacokinetics - Tmax | Day 71 | Time to reach maximum observed plasma concentration (Tmax) |
| Pharmacokinetics - t½ | Day 71 | Terminal elimination half-life (t½) |
| Immunogenicity - Anti-Drug Antibody (ADA) | Day 71 | Incidence and onset time of anti-drug antibody (ADA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events | Day 71 | Number of participants with Adverse events and Serious adverse events |
Countries
Australia
Outcome results
None listed