A Trial of SHR-1905 in Healthy Subjects and Subjects With Mild Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04905602
• Other study ID #: SHR-1905-101
• Status: Recruiting
• Phase: Phase 1
• Start date: June 15, 2021
• Est. completion date: January 13, 2022

Study information

• Verified date: May 2021
• Source: Shanghai Hengrui Pharmaceutical Co., Ltd.
• Contact: Xiaoyu Yang
• Phone: +86 18818211895
• Email: xiaoyu.yang[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a phase 1 single dose escalation study of SHR-1905 in healthy subjects and subjects with mild asthma. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of SHR-1905 in healthy subjects and subjects with mild asthma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: January 13, 2022
• Est. primary completion date: January 13, 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, and provides written informed consent, be able to comply with all the requirements and able to complete the study.

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, body mass index (BMI) between 18 and 28 kg/m2 at screening.

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

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 or plan to do surgeries during the trial.

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

4. Hyper/Hypotension which define as Systolic blood pressure (SBP) >140mmHg or <90mmHg, or Diastolic blood pressure (DBP)>90mmHg or <40mmHg at screening and at check in.

5. Clinically significant abnormalities in 12-Lead ECG (e.g., For male QTcF > 450msec, for female QTcF > 470msec) at screening and at check in

6. Positive alcohol breath test during baseline visit.

7. Positive nicotine test during screening.

8. Positive urine drug screen during screening.

9. 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 (according to the date of signed consent form) which is defined as have consented and used other investigational drugs (including placebo) or trial medical devices

10. Any other circumstances that, in the investigator's judgment, may increase the risk to the subject, or associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• SHR-1905/placebo
Drug: SHR-1905 subcutaneous, single dose Drug: Placebo subcutaneous, single dose

Locations

Country	Name	City	State
China	Shanghai Xuhui Central Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Hengrui Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

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-V/F	Apparent volume of distribution during terminal phase of SHR-1905	Start of Treament 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)