Clinical trial NCT05942612: A Phase I Study of SHR -2001 in Healthy Subjects
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-2001 After a Single Subcutaneous Injection in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-07-12
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a phase 1 single dose 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


Eligibility criteria: 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;

Primary outcomes:
measure: Adverse events
timeFrame: Start of Treatment to end of study (approximately 50 days)
Secondary outcomes:
measure: Pharmacokinetics-AUC0-t:
timeFrame: Start of Treatment to end of study (approximately 50 days)
measure: Pharmacokinetics-AUC0-inf：
timeFrame: Start of Treatment to end of study (approximately 50 days)
measure: Pharmacokinetics-Cmax：
timeFrame: Start of Treatment to end of study (approximately 50 days)
measure: Pharmacokinetics-Tmax：
timeFrame: Start of Treatment to end of study (approximately 50 days)
measure: Pharmacokinetics-t1/2：
timeFrame: Start of Treatment to end of study (approximately 50 days)
measure: Pharmacokinetics-CL/F
timeFrame: Start of Treatment to end of study (approximately 50 days))
measure: Pharmacokinetics-Vz/F
timeFrame: Start of Treatment to end of study (approximately 50 days))
measure: Anti-Drug antibody
timeFrame: Start of Treatment to end of study (approximately 50 days)
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
Study officials:
References: