A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study in Healthy Subjects

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04772365
• Other study ID #: SHR-1819-101
• Status: Completed
• Phase: Phase 1
• Start date: March 1, 2021
• Est. completion date: December 10, 2021

Study information

• Verified date: February 2021
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 10, 2021
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• SHR-1819
SHR-1819 will be subcutaneously administered with different dose levels;
• Placebo
Placebo will be subcutaneously administered with different dose levels;

Locations

Country	Name	City	State
China	The Third Xiangya Hospital of Central South University	Changsha	Changsha

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Incidence and severity of adverse events	Start of Treatment to end of study(about 13 weeks)
Secondary	Pharmacokinetics-AUC0-last	Area under the concentration-time curve from time 0 to last time point after SHR-1819 administration	Start of Treatment to end of study (about 13 weeks)
Secondary	Pharmacokinetics-AUC0-inf	Area under the concentration-time curve from time 0 to infinity after SHR-1819 administration	Start of Treatment to end of study (approximately 13 weeks)
Secondary	Pharmacokinetics-Tmax	Time to Cmax of SHR-1819	Up to 13 weeks
Secondary	Pharmacokinetics-Cmax	Maximum observed concentration of SHR-1819	Up to 13 weeks
Secondary	Pharmacokinetics-CL/F	Apparent clearance of SHR-1819	Up to 13 weeks
Secondary	Pharmacokinetics-Vz/F	Apparent volume of distribution during terminal phase of SHR-1819	Up to 13 weeks
Secondary	Pharmacokinetics-t1/2	Terminal elimination half-life of SHR-1819	Up to 13 weeks
Secondary	Change from baseline to end of treatment for Thymus and activation-regulated chemokine(TARC/CCL17)	Thymus and activation-regulated chemokine(TARC/CCL17)	Up to 13 weeks
Secondary	Change from baseline to end of treatment for IgE	IgE	Up to 13 weeks
Secondary	Immunogenicy of SHR-1819 after administration	Anti-drug antibody	Up to 13 weeks]
Secondary	Pharmacokinetics-AUCtau for multi-dose	Area under the concentration-time curve from time 0 to last time point after SHR-1819 administration	Start of Treatment to end of study (about 13 weeks)
Secondary	Pharmacokinetics- Ctrough for multi-dose	Minimum observed concentration of SHR-1819	Up to 13 weeks
Secondary	Pharmacokinetics- Racc for multi-dose	Accumulation ratio of SHR-1819	Up to 13 weeks