Skip to main content
OpenTrials
Completed

NCT Number: NCT04986540

A Trial of SHR - 1906 in Healthy Subjects

This study is a phase 1 single dose escalation study of SHR-1906 in healthy subjects. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of SHR-1906 in healthy subjects.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Phase I Clinical Research Unit, Qianfoshan Hospital of Shandong Province

Jinan, Shandong, 250014, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHR-1906;Placebo

Drug

Drug: SHR-1906 IV, single dose

Drug: Placebo IV, single dose

Primary outcomes

  1. Adverse events

    Time frame: Start of Treatment to end of study (approximately 10 weeks)

    Incidence and severity of adverse events

Secondary outcomes

  1. 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

  2. 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

  3. Pharmacokinetics-Tmax

    Time frame: Start of Treatment to end of study (approximately 10 weeks)

    Time to Cmax of SHR-1906

  4. Pharmacokinetics-Cmax

    Time frame: Start of Treatment to end of study (approximately 10 weeks)

    Maximum observed concentration of SHR-1906

  5. Pharmacokinetics-CL

    Time frame: Start of Treatment to end of study (approximately 10 weeks)

    Clearance of SHR-1906

  6. Pharmacokinetics-V

    Time frame: Start of Treatment to end of study (approximately 10 weeks)

    Volume of distribution during terminal phase of SHR-1906

  7. Pharmacokinetics-t1/2

    Time frame: Start of Treatment to end of study (approximately 10 weeks)

    Terminal elimination half-life of SHR-1906

  8. 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

Sponsors and collaborators

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 3, 2021
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.