CClinicalTrials.gg
CompletedNCT02291471Updated Jul 9, 2019

Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers

A Phase 1 interventional study of T0001,10mg and T0001,20mg in Rheumatic Diseases, sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-09.

Sponsored by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The purpose of this study to assess the MTD and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers.

02

Conditions studied

  • Rheumatic Diseases
03

In context

Rheumatic Diseases

377 studies on the registry are indexed under Rheumatic Diseases; 79 are open to participants now.

This study's enrollment of 56 is below the median of 74 across 210 interventional studies indexed under Rheumatic Diseases.

Browse Rheumatic Diseases studies →

Lead sponsor

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. is the lead sponsor of 24 studies on the registry; 6 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adult volunteers, able to give written informed consent for participation in the trial;
  • Men or women 50% each , aged 18-45 years old;
  • Subjects must have physical examination required and prove medical fitness in 7 days before the clinical starts. BMI should be between 19-24, similar BMI among subjects enrolled at the same time;

Exclusion criteria

Exclusion Criteria:

  • Acute or chronic infection, or history of active tuberculosis;
  • History of diseases of central nervous system, cardiovascular system, kidney, liver ( specified liver function index), digestive system, respiratory system , metabolism system;
  • Subjects who use 5 Unit doses tuberculin skin test are positive( 48-72 hour scleroma reading≥5mm);
  • Subjects with a history of mental problems;
  • Pregnant and lactating women or women who plan to be pregnant in 3 months;
  • Occurence of clinical significant abnormal laboratory examination value during the screening;
  • Subjects that lack of understanding ,communication or collaboration, and can't comply with the protocols;
  • Subjects that the researchers considered to be not appropriate to participate the trial due to other reasons;
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    T0001

    Drug: T0001,10mg · Drug: T0001,20mg · Drug: T0001,35mg · Drug: T0001,50mg · Drug: T0001,65mg · Drug: T0001,75mg

Interventions

  • DrugT0001,10mg
  • DrugT0001,20mg
  • DrugT0001,35mg
  • DrugT0001,50mg
  • DrugT0001,65mg
  • DrugT0001,75mg
06

What researchers measure

Primary outcomes

  1. Maximum Tolerance Dose

    Time frame: 3 weeks

Secondary outcomes

  1. Adverse events

    Time frame: 3 weeks

  2. pharmacokinetics parameter(Cmax, AUC, t1/2, CL, etc)

    Time frame: Pre-dose,2、4、12、24、36、48、60、72、84、96、120、144、168、216、264、312、384 and 480hours after the start of subcutaneous injection

07

Study locations

1 site
  • Phase I laboratory of Peking University People's Hospital
    Beijing, Beijing 100044, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02291471
Lead sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Nov 14, 2014
Start date
Oct 2014
Primary completion
Feb 2015
Completion
Feb 2015
Last update
Jul 9, 2019

Study contacts

Wang wei
study director · Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Fang Yi, Ph.D
principal investigator · Peking University People's Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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