A Study to Evaluate the Safety, Tolerability and Pharmacokinetics Pharmacodynamics of SHR-2010 by Intravenously/Subcutaneously in Healthy Subject

March 22, 2023 updated by: Guangdong Hengrui Pharmaceutical Co., Ltd

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Intravenous/Subcutaneous Injection of SHR-2010 in Healthy Subjects: a Randomized, Double-blind, Dose-increasing, Placebo-controlled Phase I Clinical Trial

The study is being conducted to Evaluate the Safety, Tolerability and Pharmacokinetics pharmacodynamics of SHR-2010 by intravenously/subcutaneously in Healthy Subject.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266555
        • The Affiliated Hospital of Qingdao University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Able and willing to provide a written informed consent.
  2. Male or non-pregnant, non-lactating female ages 18 to 55 years old.
  3. Weight ≥ 45 kg, and body mass index (BMI) must range from 18 to 28 kg/m2 .
  4. Healthy subjects as determined by absence of clinically significant abnormalities on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests performed at screening or baseline period.
  5. Subjects must be willing to use a highly effective method of contraception as deemed appropriate by the investigator throughout the study and for at least 3 months after the last study drug administration.

Exclusion Criteria:

  1. Evidence or history of serious cardiovascular, hepatic, renal, gastrointestinal, psychiatric, neurological, haematological, or metabolic diseases within 5 years.
  2. Subjects with tuberculosis diagnosed by Interferon Gamma Release Assays (IGRA) or chest X-ray.
  3. Subjects had any surgery within the past 6 months before screening or planned to undergo surgery during the study period.
  4. Estimated Glomerular Filtration Rate（eGFR）<90 mL/min/1.73m2.
  5. Positive for hepatitis (including hepatitis B and C), HIV or syphilis at screening.
  6. Systolic blood pressure (SBP) > 140 mm Hg or < 90 mm Hg, or diastolic blood pressure (DBP) > 90 mm Hg or < 60 mm Hg and has been considered clinically significant.
  7. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or gamma-glutamyl transferase (GGT) ≥2.0 x ULN, or total bilirubin ≥1.5 x ULN.
  8. Clinically significant abnormal 12-lead ECG at screening (male with QTcF > 450 ms or female with QTcF > 470 ms).
  9. Female subjects who had unprotected sexual behaviour within 14 days before screening.
  10. Positive for alcohol breath test at screening or baseline period.
  11. Positive urinary drug test at screening or baseline period.
  12. Blood collection is difficult or cannot tolerate venipuncture blood collection.
  13. Allergic to any ingredient or component in the study drug.
  14. Subjects who have taken any prescription drugs, over-the-counter drugs, or Chinese herbal medicine within 14 days prior to using the study drug.
  15. Subjects who smoked more than 5 cigarettes daily in the 1 month before screening.
  16. History of regular alcohol consumption exceeding 3 units/day for women or 5 units/day for men, more than twice per week (1 unit = 150 ml of beer or 50 ml of wine or 17 ml of alcoholic spirits) within 3 months before screening.
  17. Participated in any other clinical trials of any drug or medical device within 3 months before screening.
  18. Donated blood or blood products or had substantial loss of blood (more than 400 mL) within 1 month before screening, or received any blood or blood products within 2 months prior to screening.
  19. Subjects who received live (attenuated) vaccine within 1 month prior to screening or consider getting a vaccination during the study.
  20. The employee of investigator or study centre, with direct involvement in the proposed study.
  21. The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment for intravenously/subcutaneously
Treatment for intravenously: 6 dose groups； Treatment for subcutaneously: 3 dose groups.
Drug: SHR-2010 injection
Treatment for intravenously: 6 subjects for SR-2010 injection. Treatment for subcutaneously: 8 subjects for SR-2010 injection.
Placebo Comparator: Placebo for intravenously/subcutaneously
Treatment for intravenously: 6 dose groups； Treatment for subcutaneously: 3 dose groups.
Drug: SHR-2010 injection placebo
Treatment for intravenously: 2 subjects for placebo. Treatment for subcutaneously: 2 subjects for placebo.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety and tolerability: Incidence of subjects with adverse events (AEs)
Time Frame: Baseline up to Day 85
Incidence of AEs, including any abnormal findings in vital signs, and/or physical examination and/or clinical laboratory assessments and/or 12-lead ECG evaluation and/or IGRA.
Baseline up to Day 85

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK) parameter: AUC0-t for SHR-2010
Time Frame: Baseline up to Day 85
AUC0-t: Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration
Baseline up to Day 85
Pharmacokinetics (PK) parameter: AUC0-∞ for SHR-2010
Time Frame: Baseline up to Day 85
AUC0-∞: Area under the plasma concentration-time curve from time zero extrapolated to infinity
Baseline up to Day 85
Pharmacokinetics (PK) parameter: Cmax for SHR-2010
Time Frame: Baseline up to Day 85
Cmax: Maximum plasma concentration
Baseline up to Day 85
Pharmacokinetics (PK) parameter: Tmax for SHR-2010
Time Frame: Baseline up to Day 85
Tmax: Time to reach maximum plasma concentration
Baseline up to Day 85
Pharmacokinetics (PK) parameter: t1/2 for SHR-2010
Time Frame: Baseline up to Day 85
t1/2: Terminal half-life
Baseline up to Day 85
Pharmacokinetics (PK) parameter: CL of SHR-2010 for administration intravenously
Time Frame: Baseline up to Day 85
CL: Clearance
Baseline up to Day 85
Pharmacokinetics (PK) parameter: CL/F of SHR-2010 for administration subcutaneously
Time Frame: Baseline up to Day 85
CL/F: Apparent clearance
Baseline up to Day 85
Pharmacokinetics (PK) parameter: V of SHR-2010 for administration intravenously
Time Frame: Baseline up to Day 85
V: Volume of distribution
Baseline up to Day 85
Pharmacokinetics (PK) parameter: V/F of SHR-2010 for administration subcutaneously
Time Frame: Baseline up to Day 85
V/F: Apparent volume of distribution
Baseline up to Day 85
Pharmacokinetics (PK) parameter: Bioavailability (F) of SHR-2010
Time Frame: Baseline up to Day 85
Bioavailability of SHR-2010 for administration subcutaneously.
Baseline up to Day 85
Pharmacodynamics (PD): C4b level in the serum
Time Frame: Baseline up to Day 85
C4b level in the serum.
Baseline up to Day 85
Immunogenicity: Proportion of anti-drug antibodies (ADA) positive subjects
Time Frame: Baseline up to Day 85
Proportion of anti-drug antibodies (ADA) positive subjects.
Baseline up to Day 85

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHR-2010-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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