Healthy
Conditions
Brief summary
This study is a phase 1 single dose or multiple doses escalation study of SHR-2001 in healthy subjects. The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-2001 in healthy subjects.
Interventions
DRUGSHR-2001
Subcutaneous injection, single dose or multiple doses.
DRUGPlacebo
Subcutaneous injection, single dose or multiple doses.
Sponsors
Guangdong Hengrui Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Obtain informed consent from participants before the start of any study related activities. Participants must have a full understanding of the purpose and significance of the trial, and be willing to comply with the trial protocol; 2. Age 18 \ 55 years old (including boundary value), male or female; 3. Weight ≥ 45 kg, body mass index (BMI) ranging 19 \ 28 kg/m2 (including boundary value); 4. Participants who are overtly healthy as determined by medical history and physical examination.; 5. Participants and their partners have no fertility plan and voluntarily use highly effective contraception. Female subjects must have a negative serum pregnancy test and be non-lactating.
Exclusion criteria
1. Those who have serious systemic diseases within 3 months before screening or administration, and the investigator believes that there may be safety risks; 2. Those who have serious infection, severe trauma or major surgery within 6 months before screening or administration; those who plan to undergo surgery during the trial; 3. Inactivated vaccine received within 2 weeks prior to randomization or live attenuated vaccine within 3 months prior to randomization, or intended to be vaccinated during the study period;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Start of Treatment to end of study (approximately 64 days). | Incidence and severity of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics-AUC0-inf | Start of Treatment to end of study (approximately 64 days). | Area under the concentration-time curve from time 0 to infinity after SHR-2001 administration |
| Pharmacokinetics-Cmax | Start of Treatment to end of study (approximately 64 days). | Maximum observed concentration of SHR-2001 |
| Pharmacokinetics-Tmax | Start of Treatment to end of study (approximately 64 days). | Time to Cmax |
| Pharmacokinetics-AUC0-t | Start of Treatment to end of study (approximately 64 days). | Area under the concentration-time curve from 0 to the last measurable time point after SHR-2001 administration |
| Pharmacokinetics-CL/F | Start of Treatment to end of study (approximately 64 days). | Apparent clearance of SHR-2001 |
| Pharmacokinetics-Vz/F | Start of Treatment to end of study (approximately 64 days). | Apparent volume of distribution during terminal phase of SHR-2001 |
| Anti-Drug antibody | Start of Treatment to end of study (approximately 64 days). | The percentage of subjects with positive ADA |
| Pharmacokinetics-t1/2 | Start of Treatment to end of study (approximately 64 days). | Terminal elimination half-life of SHR-2001 |
Countries
China
Outcome results
None listed