A Trial of SHR-1819 in Healthy Subjects

NCT04561128 | Completed Phase 1 DMC

• 1 other identifier: SHR-1819-I-101-AUS
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Incidence and severity of adverse events

  Start of Treatment to end of study (approximately 13 weeks)

Secondary Outcomes (10)

• Pharmacokinetics-AUC0-last

  Start of Treatment to end of study (approximately 13 weeks)

• Pharmacokinetics-AUC0-inf

  Start of Treatment to end of study (approximately 13 weeks)

• Pharmacokinetics-Tmax

  Up to 13 weeks

• Pharmacokinetics-Cmax

  Up to 13 weeks

• Pharmacokinetics-CL/F

  Up to 13 weeks

Study Arms (2)

SHR-1819

EXPERIMENTAL

Experimental: SHR-1819

Drug: SHR-1819

Placebo

PLACEBO COMPARATOR

Placebo comparator: placebo

Drug: Placebo

Interventions

SHR-1819 DRUG

SHR-1819 will be subcutaneously administered with different dose levels

SHR-1819

Placebo DRUG

Placebo will be subcutaneously administered with different dose levels

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

Study Sites (1)

Atridia Pty Limited

Sydney, New South Wales, 2000, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2020
• First Posted: September 23, 2020
• Study Start: November 1, 2020
• Primary Completion: March 7, 2022
• Study Completion: March 7, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Locations

AU (1)