A Trial of SHR-1905 in Healthy Subjects

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: SHR-1905; Drug: Placebo

• Registration Number: NCT04800263
• Lead Sponsor: Atridia Pty Ltd.

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-16
• Study Start: 2021-07-27
• Primary Completion: 2022-11-12
• Study Completion: 2022-11-12
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR-1905 Dose Level 3	SHR-1905	SHR-1905 Dose level 3
SHR-1905 Dose Level 3	Placebo	SHR-1905 Dose level 3
SHR-1905 Dose Level 2	Placebo	SHR-1905 Dose level 2
SHR-1905 Dose Level 1	Placebo	SHR-1905 Dose level 1
SHR-1905 Dose Level 4	SHR-1905	SHR-1905 Dose level 4
SHR-1905 Dose Level 5	Placebo	SHR-1905 Dose level 5
SHR-1905 Dose Level 4	Placebo	SHR-1905 Dose level 4
SHR-1905 Dose Level 1	SHR-1905	SHR-1905 Dose level 1
SHR-1905 Dose Level 5	SHR-1905	SHR-1905 Dose level 5
SHR-1905 Dose Level 2	SHR-1905	SHR-1905 Dose level 2

Primary Outcome Measures

Name	Time	Method
Adverse events	Start of Treatment to end of study (approximately 16 weeks)	Incidence and severity of adverse events

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nucleus Network; 🇦🇺 Brisbane, Queensland, Australia