Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Pharmacokinetic Study of RO4917838 in Healthy Chinese Volunteers

NCT01433575

Healthy Volunteer

COMPLETED PHASE1

A Study to Assess the Effect of Food on the Pharmacokinetics of TY-9591 in Healthy Volunteers

NCT04798638

Healthy Volunteers

COMPLETED PHASE1

A Bioavailability Study of SHR1459 on Healthy Chinese Volunteers

NCT04395053

Healthy Adult Subjects

COMPLETED PHASE1

A Pharmacokinetic Study of TQB3101 in Chinese Healthy Subjects

NCT04804904

Pharmacokinetic Study

COMPLETED PHASE1

Single-dose, Pharmacokinetics of AMG 853 in Healthy Adult Subjects

NCT01124279

Healthy Volunteers

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatic Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

T0001

Group Type EXPERIMENTAL

T0001，10mg

Intervention Type DRUG

T0001，20mg

Intervention Type DRUG

T0001，35mg

Intervention Type DRUG

T0001，50mg

Intervention Type DRUG

T0001，65mg

Intervention Type DRUG

T0001，75mg

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

T0001，10mg

Intervention Type DRUG

T0001，20mg

Intervention Type DRUG

T0001，35mg

Intervention Type DRUG

T0001，50mg

Intervention Type DRUG

T0001，65mg

Intervention Type DRUG

T0001，75mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes