SHR-1139 Injection: Single dose of SHR-1139 given subcutaneously (dose level 1 )
SHR-1139 Injection: Single dose of SHR-1139 given subcutaneously (dose level 2 )
SHR-1139 Injection: Single dose of SHR-1139 given intravenously (dose level 3)
Study summary
The purpose of this study is to assess safety, PK and immunogenicity profile of a single dose of SHR-1139 in healthy volunteers
Eligibility
Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
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/Exclusion criteria may apply
Primary outcome measure(s)
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 — From time 0 to infinity after SHR-1139 administration (Day 253) Pharmacokinetics- Area under the concentration-time curve (AUC0-inf)
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 )
PK profile of SHR-1139 after a single administration — Start of Treatment to end of study (Day 253) Pharmacokinetics-Terminal elimination half-life of SHR-1139 (t1/2)
Immunogenicity profile of SHR-1139 after a single dose administration — Day 253 The number of participants with anti-drug antibody (ADA)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.