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Completed

NCT Number: NCT04800263

A Trial of SHR-1905 in Healthy Subjects

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 and immunogenicity of subcutaneous administered SHR-1905 in healthy subjects.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network

Brisbane, Queensland, Australia

About this study

The study will consist of one dose esclation part with a total of 5 dose levels. The Subjects will be randomized to receive SHR-1905 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.

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.
  • Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
  • Total body weight ≥45 kg at screening, and body mass index (BMI) between 18 and 28 kg/m2 (inclusive).
  • For healthy subjects, no clinically significant abnormalities.
  • Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods

Exclusion criteria

  • Known medical history of severe disease in cardiovascular, liver, kidney, digestive tract, mental nerve, hematology, metabolic disorders, etc.
  • Severe injuries or major surgeries within 6 months before screening.
  • Subjects with infecious disease.
  • Hyper/Hypotension at screening and at check in.
  • Clinically significant abnormalities in 12-Lead ECG
  • More than 5 cigarettes daily (or products with equivalent amount of nicotine) for 3 months prior to screening
  • Positive urine drug screen .
  • Subject who cannot perform venous blood sampling.
  • Known history or suspected of being allergic to the study drugs and their excipients.
  • Use of any medicine within 4-weeks or within 5 half-lives
  • History of alcohol abuse within 3 months prior to the IP administration .
  • Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening
  • in the investigator's judgment, may increase the risk to the subject

Treatment and study plan

SHR-1905

Drug

SHR-1905 will be injected subcutaneously

Placebo

Drug

Placebo will be injected subcutaneously

Primary outcomes

  1. Adverse events

    Time frame: Start of Treatment to end of study (approximately 16 weeks)

    Incidence and severity of adverse events

Secondary outcomes

  1. Pharmacokinetics-AUC0-last

    Time frame: Start of Treatment to end of study (approximately 16 weeks)

    Area under the concentration-time curve from time 0 to last time point after SHR-1905 administration

  2. Pharmacokinetics-AUC0-inf

    Time frame: Start of Treatment to end of study (approximately 16 weeks)

    Area under the concentration-time curve from time 0 to infinity after SHR-1905 administration

  3. Pharmacokinetics-Tmax

    Time frame: Start of Treatment to end of study (approximately 16 weeks)

    Time to Cmax of SHR-1905

  4. Pharmacokinetics-Cmax

    Time frame: Start of Treatment to end of study (approximately 16 weeks)

    Maximum observed concentration of SHR-1905

  5. Pharmacokinetics-CL/F

    Time frame: Start of Treatment to end of study (approximately 16 weeks)

    Apparent clearance of SHR-1905

  6. Pharmacokinetics-Vz/F

    Time frame: Start of Treatment to end of study (approximately 16 weeks)

    Apparent volume of distribution during terminal phase of SHR-1905

  7. Pharmacokinetics-t1/2

    Time frame: Start of Treatment to end of study (approximately 16 weeks)

    Terminal elimination half-life of SHR-1905

  8. Anti-Drug antibody

    Time frame: Start of Treatment to end of study (approximately 16 weeks)

    The percentage of subjects with positive ADA titers over time for SHR-1905

Sponsors and collaborators

Lead sponsor

Atridia Pty 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 Subcutaneous Administered SHR-1905 in Healthy Subjects

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2021
Registry last updated
May 10, 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.

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