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Completed

NCT Number: NCT04905602

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai Xuhui Central Hospital

Shanghai, Shanghai Municipality, 200031, 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, body mass index (BMI) between 18 and 28 kg/m2 at screening.
  • 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

  • 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 or plan to do surgeries during the trial.
  • Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab) at screening.
  • 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.
  • Clinically significant abnormalities in 12-Lead ECG (e.g., For male QTcF > 450msec, for female QTcF > 470msec) at screening and at check in
  • Positive alcohol breath test during baseline visit.
  • Positive nicotine test during screening.
  • Positive urine drug screen during screening.
  • 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
  • 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

Treatment and study plan

SHR-1905/placebo

Drug

Drug: SHR-1905 subcutaneous, single dose

Drug: Placebo subcutaneous, single dose

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-V/F

    Time frame: Start of Treament 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

Shanghai 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 Pharmacodynamics of Single Subcutaneous Administered SHR-1905 in Healthy Subjects and Subjects With Mild Asthma.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 27, 2021
Registry last updated
Oct 30, 2024

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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