NCT04800263

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 asthma

Timeline
Completed

Started Jul 2021

Typical duration for phase_1 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

July 27, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2022

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

1.3 years

First QC Date

March 11, 2021

Last Update Submit

May 8, 2023

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    Incidence and severity of adverse events

    Start of Treatment to end of study (approximately 16 weeks)

Secondary Outcomes (8)

  • Pharmacokinetics-AUC0-last

    Start of Treatment to end of study (approximately 16 weeks)

  • Pharmacokinetics-AUC0-inf

    Start of Treatment to end of study (approximately 16 weeks)

  • Pharmacokinetics-Tmax

    Start of Treatment to end of study (approximately 16 weeks)

  • Pharmacokinetics-Cmax

    Start of Treatment to end of study (approximately 16 weeks)

  • Pharmacokinetics-CL/F

    Start of Treatment to end of study (approximately 16 weeks)

  • +3 more secondary outcomes

Study Arms (5)

SHR-1905 Dose Level 1

EXPERIMENTAL

SHR-1905 Dose level 1

Drug: SHR-1905Drug: Placebo

SHR-1905 Dose Level 2

EXPERIMENTAL

SHR-1905 Dose level 2

Drug: SHR-1905Drug: Placebo

SHR-1905 Dose Level 3

EXPERIMENTAL

SHR-1905 Dose level 3

Drug: SHR-1905Drug: Placebo

SHR-1905 Dose Level 4

EXPERIMENTAL

SHR-1905 Dose level 4

Drug: SHR-1905Drug: Placebo

SHR-1905 Dose Level 5

EXPERIMENTAL

SHR-1905 Dose level 5

Drug: SHR-1905Drug: Placebo

Interventions

SHR-1905DRUG

SHR-1905 will be injected subcutaneously

SHR-1905 Dose Level 1SHR-1905 Dose Level 2SHR-1905 Dose Level 3SHR-1905 Dose Level 4SHR-1905 Dose Level 5
PlaceboDRUG

Placebo will be injected subcutaneously

SHR-1905 Dose Level 1SHR-1905 Dose Level 2SHR-1905 Dose Level 3SHR-1905 Dose Level 4SHR-1905 Dose Level 5

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nucleus Network

Brisbane, Queensland, Australia

Location

Related Publications (1)

  • Fei Y, Li N, Qian W, Fan Y, Shen Y, Wang Q, McLendon K, Shen K. A phase 1, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-1905, a long-acting anti-thymic stromal lymphopoietin antibody, in healthy subjects. Front Pharmacol. 2024 Jul 15;15:1400696. doi: 10.3389/fphar.2024.1400696. eCollection 2024.

    PMID: 39076593DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 16, 2021

Study Start

July 27, 2021

Primary Completion

November 12, 2022

Study Completion

November 12, 2022

Last Updated

May 10, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)