Linear
Perth, Western Australia, Australia
NCT Number: NCT07078695
The purpose of this study is to assess safety, PK and immunogenicity profile of a single dose of SHR-1139 in healthy volunteers
This study is active but is not currently recruiting participants.
Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Perth, Western Australia, Australia
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Single dose of SHR-1139 given subcutaneously (dose level 1 )
Time frame: 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)
Time frame: From time 0 to infinity after SHR-1139 administration (Day 253)
Pharmacokinetics- Area under the concentration-time curve (AUC0-inf)
Time frame: Start of Treatment to end of study (Day 253)
Pharmacokinetics- Time to Cmax of SHR-1139 (Tmax )
Time frame: Start of Treatment to end of study (Day 253)
Pharmacokinetics-Terminal elimination half-life of SHR-1139 (t1/2)
Time frame: Day 253
The number of participants with anti-drug antibody (ADA)
Time frame: Day 295
Number of participants with Adverse events and Serious adverse events
Atridia Pty Ltd.
Industry
A Phase 1, Randomized, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Subcutaneous/Intravenous Administered SHR-1139 in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03218488
Psoriasis, Skin Diseases
Graz, Austria
View Trial DetailsNCT00508547
Arthritis, Arthritis, Psoriatic
Birmingham, Alabama, United States
View Trial DetailsNCT03451851
Psoriasis, Skin Diseases
Palo Alto, California, United States
View Trial DetailsNCT07623486
Psoriasis, Skin Diseases
Hangzhou, Zhejiang, China
View Trial Details