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CompletedNCT04701216Updated Nov 9, 2021

A Trial of SHR8735 in Healthy Subjects

A Phase 1 interventional study of SHR8735 in Healthy Volunteers, sponsored by Atridia Pty Ltd.. Completed at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-09.

Sponsored by Atridia Pty Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This is a phase 1 open-label study.

Read the detailed description

This is a phase 1 open-label study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral administered SHR8735 in healthy subjects

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Atridia Pty Ltd. is the lead sponsor of 34 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.
  • No clinically significant abnormalities in medical history, general physical examination, vital signs, and laboratory tests.
  • Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods and have no plan to have a child from signing the consent form to 16 weeks after IP administration.

Exclusion criteria

Exclusion Criteria:

  • Receipt of any other investigational drugs or medical devices within 3 months prior to screening (according to the date of signed consent form).
  • History of illicit or prescription drug abuse or addiction within one year of screening, or positive urine drug screen at screening and Day-1. The urine drug screen may be repeated at the discretion of the investigator and the reason for repeat needs to be documented clearly (e.g., suspicion of false positive due to diet).
  • Severe, active psychiatric conditions that require ongoing treatment.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Experimental: SHR8735 cohort 1

    The subjects will receive a multiple dose of SHR8735 (low dose).

    Drug: SHR8735

  • Experimental
    Experimental: SHR8735 cohort 2

    The subjects will receive a single dose of SHR8735 (medium dose).

    Drug: SHR8735

  • Experimental
    Experimental: SHR8735 cohort 3

    The subjects will receive a single dose of SHR8735 (high dose).

    Drug: SHR8735

Interventions

  • DrugSHR8735

    SHR8735 is an thrombopoietin receptor agonist to promote platelet production.

06

What researchers measure

Primary outcomes

  1. Adverse events

    Incidence and severity of adverse events

    Time frame: Start of Treatment to end of study (approximately 28 days)

Secondary outcomes

  1. Pharmacokinetics-AUC0-last

    Area under the concentration-time curve from time 0 to last time point after SHR8735 administration

    Time frame: Start of Treatment to end of study (approximately 15 days)

  2. Pharmacokinetics-AUC0-inf

    Area under the concentration-time curve from time 0 to infinity after SHR8735 administration

    Time frame: Start of Treatment to end of study (approximately 15 days)

  3. Pharmacokinetics-Tmax

    Time to Cmax of SHR8735

    Time frame: Up to 15 days

  4. Pharmacokinetics-Cmax

    Maximum observed concentration of SHR8735

    Time frame: Up to 15 days

  5. Pharmacokinetics-CL/F

    Apparent clearance of SHR8735

    Time frame: Up to 15 days

  6. Pharmacokinetics-Vz/F

    Apparent volume of distribution during terminal phase of SHR8735

    Time frame: Up to 15 days

  7. Pharmacokinetics-t1/2

    Terminal elimination half-life of SHR8735

    Time frame: Up to 15 days

  8. Change from baseline to end of treatment for platelet count

    Time frame: Up to 28 days

07

Study locations

1 site
  • Linear Clinical research
    Perth, Western Australia 6009, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04701216
Lead sponsor
Atridia Pty Ltd.
Responsible party
Sponsor
First posted
Jan 8, 2021
Start date
Feb 11, 2021
Primary completion
Jul 15, 2021
Completion
Jul 15, 2021
Last update
Nov 9, 2021

Study contacts

Ana Sun, Dr
principal investigator · Study Principal Investigator

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.

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