Clinical trial NCT04772365: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study in Healthy Subjects
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administered SHR-1819 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-02-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief summary: This is a single center, randomized, double-blind, placebo-controlled, single and multiple dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous administered SHR-1819 in healthy subjects


Eligibility criteria: Inclusion Criteria:

1. Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent.
2. Be able to comply with all the requirements and able to complete the study.
3. Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
4. No clinically significant abnormalities in medical history, general physical examination, vital signs, and laboratory tests.
5. Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods and have no plan to have a child from signing the consent form to 16 weeks after IP administration.

Exclusion Criteria:

1. Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab), or QuantiFERON-TB Gold tests at screening;
2. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening (according to the date of signed consent form), or in the follow-up period of a clinical study
3. Severe injuries or surgeries within 6 months before screening or plan to do surgeries during the trial
4. Any other circumstances that, in the investigator's judgment, may increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response

Primary outcomes:
measure: Adverse events
timeFrame: Start of Treatment to end of study（about 13 weeks）
Secondary outcomes:
measure: Pharmacokinetics-AUC0-last
timeFrame: Start of Treatment to end of study (about 13 weeks)
measure: Pharmacokinetics-AUC0-inf
timeFrame: Start of Treatment to end of study (approximately 13 weeks)
measure: Pharmacokinetics-Tmax
timeFrame: Up to 13 weeks
measure: Pharmacokinetics-Cmax
timeFrame: Up to 13 weeks
measure: Pharmacokinetics-CL/F
timeFrame: Up to 13 weeks
measure: Pharmacokinetics-Vz/F
timeFrame: Up to 13 weeks
measure: Pharmacokinetics-t1/2
timeFrame: Up to 13 weeks
measure: Change from baseline to end of treatment for Thymus and activation-regulated chemokine（TARC/CCL17）
timeFrame: Up to 13 weeks
measure: Change from baseline to end of treatment for IgE
timeFrame: Up to 13 weeks
measure: Immunogenicy of SHR-1819 after administration
timeFrame: Up to 13 weeks]
measure: Pharmacokinetics-AUCtau for multi-dose
timeFrame: Start of Treatment to end of study (about 13 weeks)
measure: Pharmacokinetics- Ctrough for multi-dose
timeFrame: Up to 13 weeks
measure: Pharmacokinetics- Racc for multi-dose
timeFrame: Up to 13 weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Changsha
Study officials:
References: