A Trial of SHR-1905 in Healthy Subjects

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04800263
• Other study ID #: SHR-1905-I-101-AUS
• Status: Completed
• Phase: Phase 1
• Start date: July 27, 2021
• Est. completion date: November 12, 2022

Study information

• Verified date: May 2023
• Source: Atridia Pty Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 12, 2022
• Est. primary completion date: November 12, 2022
• 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.

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• SHR-1905
SHR-1905 will be injected subcutaneously
• Placebo
Placebo will be injected subcutaneously

Locations

Country	Name	City	State
Australia	Nucleus Network	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Atridia Pty Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	Incidence and severity of adverse events	Start of Treatment to end of study (approximately 16 weeks)
Secondary	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)
Secondary	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)
Secondary	Pharmacokinetics-Tmax	Time to Cmax of SHR-1905	Start of Treatment to end of study (approximately 16 weeks)
Secondary	Pharmacokinetics-Cmax	Maximum observed concentration of SHR-1905	Start of Treatment to end of study (approximately 16 weeks)
Secondary	Pharmacokinetics-CL/F	Apparent clearance of SHR-1905	Start of Treatment to end of study (approximately 16 weeks)
Secondary	Pharmacokinetics-Vz/F	Apparent volume of distribution during terminal phase of SHR-1905	Start of Treatment to end of study (approximately 16 weeks)
Secondary	Pharmacokinetics-t1/2	Terminal elimination half-life of SHR-1905	Start of Treatment to end of study (approximately 16 weeks)
Secondary	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)