A Trial of SHR-1819 in Healthy Subjects | NCT04561128

Studies
A Trial of SHR-1819 in Healthy Subjects

NCT04561128

Sponsor

Atridia Pty Ltd.

Status

Completed

Last Update Posted

Jul 12, 2022Actual

Enrollment

42Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

SHR-1819
Placebo

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2020Actual

Primary Completion Date

Mar 7, 2022Actual

Completion Date

Mar 7, 2022Actual

First Submitted Date

Aug 29, 2020

First Submission Date that Met QC Criteria

Sep 17, 2020

First Posted Date

Sep 23, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2022

Last Update Posted Date

Jul 12, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a single center, randomized, double-blind, placebo-controlled, single dose escalation phase 1 study.

Detailed Description

This is a single center, randomized, double-blind, placebo-controlled, single 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SHR-1819	Experimental	Experimental: SHR-1819	Drug: SHR-1819
Placebo	Placebo Comparator	Placebo comparator: placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SHR-1819	Drug	SHR-1819 will be subcutaneously administered with different dose levels	SHR-1819

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events	Incidence and severity of adverse events	Start of Treatment to end of study (approximately 13 weeks)

Secondary Outcomes

Measure	Description	Time Frame
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 (approximately 13 weeks)
Pharmacokinetics-AUC0-inf

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent.
Be able to comply with all the requirements and able to complete the study.
Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
No clinically significant abnormalities in medical history, general physical examination, vital signs, and laboratory tests.
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:

Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab), or QuantiFERON-TB Gold tests at screening;
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
Severe injuries or surgeries within 6 months before screening or plan to do surgeries during the trial
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided