A Trial of SHR-1905 in Healthy Subjects

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Single Subcutaneous Administered SHR-1905 in Healthy Subjects

This is a randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of subcutaneous administered SHR-1905 in healthy subjects.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: SHR-1905; Drug: Placebo

Detailed Description

The study will consist of one dose esclation part with a total of 5 dose levels. The Subjects will be randomized to receive SHR-1905 as reflected by the guiding principle for the dose esclation/expansion phase. Each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia
      • Nucleus Network

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial.
2. Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
3. Total body weight ≥45 kg at screening, and body mass index (BMI) between 18 and 28 kg/m2 (inclusive).
4. For healthy subjects, no clinically significant abnormalities.
5. Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods

Exclusion Criteria:

1. Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc.
2. Severe injuries or major surgeries within 6 months before screening.
3. Subjects with infecious disease.
4. Hyper/Hypotension at screening and at check in.
5. Clinically significant abnormalities in 12-Lead ECG
6. More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening
7. Positive urine drug screen .
8. Subject who cannot perform venous blood sampling.
9. Known history or suspected of being allergic to the study drugs and their excipients.
10. Use of any medicine within 4-weeks or within 5 half-lives
11. History of alcohol abuse within 3 months prior to the IP administration .
12. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening
13. in the investigator's judgment, may increase the risk to the subject

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-1905 Dose Level 1; SHR-1905 Dose level 1	Drug: SHR-1905; SHR-1905 will be injected subcutaneously; Drug: Placebo; Placebo will be injected subcutaneously
Experimental: SHR-1905 Dose Level 2; SHR-1905 Dose level 2	Drug: SHR-1905; SHR-1905 will be injected subcutaneously; Drug: Placebo; Placebo will be injected subcutaneously
Experimental: SHR-1905 Dose Level 3; SHR-1905 Dose level 3	Drug: SHR-1905; SHR-1905 will be injected subcutaneously; Drug: Placebo; Placebo will be injected subcutaneously
Experimental: SHR-1905 Dose Level 4; SHR-1905 Dose level 4	Drug: SHR-1905; SHR-1905 will be injected subcutaneously; Drug: Placebo; Placebo will be injected subcutaneously
Experimental: SHR-1905 Dose Level 5; SHR-1905 Dose level 5	Drug: SHR-1905; SHR-1905 will be injected subcutaneously; Drug: Placebo; Placebo will be injected subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Incidence and severity of adverse events	Start of Treatment to end of study (approximately 16 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics-AUC0-last	Area under the concentration-time curve from time 0 to last time point after SHR-1905 administration	Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-AUC0-inf	Area under the concentration-time curve from time 0 to infinity after SHR-1905 administration	Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-Tmax	Time to Cmax of SHR-1905	Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-Cmax	Maximum observed concentration of SHR-1905	Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-CL/F	Apparent clearance of SHR-1905	Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-Vz/F	Apparent volume of distribution during terminal phase of SHR-1905	Start of Treatment to end of study (approximately 16 weeks)
Pharmacokinetics-t1/2	Terminal elimination half-life of SHR-1905	Start of Treatment to end of study (approximately 16 weeks)
Anti-Drug antibody	The percentage of subjects with positive ADA titers over time for SHR-1905	Start of Treatment to end of study (approximately 16 weeks)

Collaborators and Investigators

• Sponsor: Atridia Pty Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2021
• Primary Completion (Actual): November 12, 2022
• Study Completion (Actual): November 12, 2022

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 12, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SHR-1905-I-101-AUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No