A Trial of SHR-1703 in Healthy Subjects

Asthma Clinical Trial

Official title:

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Evaluate the Safety, Tolerability, PK, PD and Immunogenicity of Single Subcutaneous Administered SHR-1703 in Healthy Caucasian Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04855591
• Other study ID #: SHR-1703-104-AUS
• Status: Terminated
• Phase: Phase 1
• Start date: June 14, 2021
• Est. completion date: November 18, 2021

Study information

• Verified date: November 2021
• 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 pharmacodynamics and immunogenicity of subcutaneous administered SHR-1703 in healthy subjects.

Description:

The study will consist of one dose esclation part with a total of 3 dose levels. The Subjects will be randomized to receive SHR-1703 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: Terminated
• Enrollment: 1
• Est. completion date: November 18, 2021
• Est. primary completion date: September 13, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Healthy Caucasian subjects, male and female, 18 to 55 years of age, inclusive;

2. Body weight =45 kg (Both male and female), body mass index (BMI) between =19.0 and =29.9 kg/m2, inclusive;

3. No clinically significant abnormalities in medical history, general physical examination, vital signs, laboratory tests (hematology, urinalysis, blood chemistry and coagulation function) and ECG at the investigator's discretion during screening and baseline.

4. 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 30-days after last scheduled follow-up visit.

Exclusion Criteria:

1. Known history or suspected of being allergic to the study drug.

2. Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab) at screening.

3. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening or within 5 half-lives of any drugs during screening visit, or in the follow-up period of a clinical study whichever is longer

4. Use of any medicine within 4-weeks prior to the IP administration

5. Blood donation or loss of more than 400 mL of blood within 1 month of screening; or received blood transfusion within 2 months before screening.

6. Live (attenuated) vaccination within 1 month before screening or plan to be vaccinated

7. Severe injuries or major surgeries within 6 months before screening or plan to do surgeries during the trial

8. Patients with known or suspected parasitic infection within 6 months before screening

9. Either ALT, AST, ALP, GGT or total bilirubin level exceeds upper limit of normal range (ULN) at screening or baseline visits (confirmed by a single repeat, as per investigator's judgment)

10. More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening.

11. History of alcohol abuse within 3 months prior to the IP administration

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• SHR-1703
SHR-1703 will be administered subcutaneously
• Placebo
Placebo of SHR-1703 will be administered 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 34 weeks)
Secondary	Pharmacokinetics-AUC0-last	Area under the concentration-time curve from time 0 to last time point after SHR-1703 administration	Start of Treatment to end of study (approximately 34 weeks)
Secondary	Pharmacokinetics-AUC0-inf	Area under the concentration-time curve from time 0 to infinity after SHR-1703 administration	Start of Treatment to end of study (approximately 34 weeks)
Secondary	Pharmacokinetics-Tmax	Time to Cmax of SHR-1703	Start of Treatment to end of study (approximately 34 weeks)
Secondary	Pharmacokinetics-Cmax	Maximum observed concentration of SHR-1703	Start of Treatment to end of study (approximately 34 weeks)
Secondary	Pharmacokinetics-CL/F	Apparent clearance of SHR-1703	Start of Treatment to end of study (approximately 34 weeks)
Secondary	Pharmacokinetics-Vz/F	Apparent volume of distribution during terminal phase of SHR-1703	Start of Treatment to end of study (approximately 34 weeks)
Secondary	Pharmacokinetics-t1/2	Terminal elimination half-life of SHR-1703	Start of Treatment to end of study (approximately 34 weeks)
Secondary	Pharmacodynamics-Eosinophils	Absolute eosinophils account and change from baseline in percentage	Start of Treatment to end of study (approximately 34 weeks)
Secondary	Anti-drug-antibody	The percentage of subjects with positive ADA titers over time for SHR-1703	Start of Treatment to week 22 after IP administration