A Trial of SHR - 1906 in Healthy Subjects
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single IV Infusion of SHR-1906 in Healthy Subjects
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Shandong
-
Jinan, Shandong, China, 250014
- Phase I Clinical Research Unit, Qianfoshan Hospital of Shandong Province
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
- Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
- Total body weight ≥ 45 kg.
- 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
- Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods
Exclusion Criteria:
- History of serious cardiovascular, liver, kidney, digestive tract, psychiatric, hematology, metabolic disorders, primary immunodeficiency disease or acquired immune deficiency syndrome, or organ transplantation.
- Severe infections, injuries or major surgeries (as determined by the investigator) within 6 months prior to screening, or plan to do any surgery during the trial.
- Positive testing for human immunodeficiency virus (HIV-Ab), or hepatitis B surface antigen (HBsAg), or TP-Ab , or hepatitis C antibodies (HCV-Ab).
- Screening/baseline systolic blood pressure (BP) ≥140 mmHg or ≤90 mmHg; diastolic BP ≥90 mmHg or <60 mmHg on a single measurement
- Positive urine drug screening at baseline;
- Use of any medicine within 1 monthes (including any prescription, or over-the-counter medicine, herbal remedy or nutritional supplement, except for vitamins and occasional use of acetaminophen with recommended dose), or within 5 half-lives of any drugs whichever is longer prior to dosing, or plan to use any medicine during the trial.
- 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 having consented and used other investigational drugs (including placebo) or trial medical devices.
- Blood donation or loss of ≥ 400 mL of blood within 1 months; or received blood or blood products within 2 months prior to screening.
- Any other circumstances that, in the investigator's judgment, may increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response.
- Researchers and relevant staff of the research center or other persons directly involved in the implementation of the program.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Cohort 1
A single subcutaneous injection of SHR-1906/placebo dose 1 in healthy subjects
|
Drug: SHR-1906 IV, single dose Drug: Placebo IV, single dose |
|
Experimental: Cohort 2
A single subcutaneous injection of SHR-1906/placebo dose 2 in healthy subjects
|
Drug: SHR-1906 IV, single dose Drug: Placebo IV, single dose |
|
Experimental: Cohort 3
A single subcutaneous injection of SHR-1906/placebo dose 3 in healthy subjects
|
Drug: SHR-1906 IV, single dose Drug: Placebo IV, single dose |
|
Experimental: Cohort 4
A single subcutaneous injection of SHR-1906/placebo dose 4 in healthy subjects
|
Drug: SHR-1906 IV, single dose Drug: Placebo IV, single dose |
|
Experimental: Cohort 5
A single subcutaneous injection of SHR-1906/placebo dose 5 in healthy subjects
|
Drug: SHR-1906 IV, single dose Drug: Placebo IV, single dose |
|
Experimental: Cohort 6
A single subcutaneous injection of SHR-1906/placebo dose 6 in healthy subjects
|
Drug: SHR-1906 IV, single dose Drug: Placebo IV, single dose |
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse events
Time Frame: Start of Treatment to end of study (approximately 10 weeks)
|
Incidence and severity of adverse events
|
Start of Treatment to end of study (approximately 10 weeks)
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pharmacokinetics-AUC0-last
Time Frame: Start of Treatment to end of study (approximately 10 weeks)
|
Area under the concentration-time curve from time 0 to last time point after SHR-1906 administration
|
Start of Treatment to end of study (approximately 10 weeks)
|
|
Pharmacokinetics-AUC0-inf
Time Frame: Start of Treatment to end of study (approximately 10 weeks)
|
Area under the concentration-time curve from time 0 to infinity after SHR-1906 administration
|
Start of Treatment to end of study (approximately 10 weeks)
|
|
Pharmacokinetics-Tmax
Time Frame: Start of Treatment to end of study (approximately 10 weeks)
|
Time to Cmax of SHR-1906
|
Start of Treatment to end of study (approximately 10 weeks)
|
|
Pharmacokinetics-Cmax
Time Frame: Start of Treatment to end of study (approximately 10 weeks)
|
Maximum observed concentration of SHR-1906
|
Start of Treatment to end of study (approximately 10 weeks)
|
|
Pharmacokinetics-CL
Time Frame: Start of Treatment to end of study (approximately 10 weeks)
|
Clearance of SHR-1906
|
Start of Treatment to end of study (approximately 10 weeks)
|
|
Pharmacokinetics-V
Time Frame: Start of Treatment to end of study (approximately 10 weeks)
|
Volume of distribution during terminal phase of SHR-1906
|
Start of Treatment to end of study (approximately 10 weeks)
|
|
Pharmacokinetics-t1/2
Time Frame: Start of Treatment to end of study (approximately 10 weeks)
|
Terminal elimination half-life of SHR-1906
|
Start of Treatment to end of study (approximately 10 weeks)
|
|
Anti-Drug antibody
Time Frame: Start of Treatment to end of study (approximately 10 weeks)
|
The percentage of subjects with positive ADA titers over time for SHR-1906
|
Start of Treatment to end of study (approximately 10 weeks)
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- SHR-1906-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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