Rheumatic DiseasesPhase 1NCT02291471

Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers

A Phase 1 study testing T0001，10mg, T0001，20mg and T0001，35mg in people with Rheumatic Diseases, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Rheumatic Diseases
What is being tested?: T0001，10mg, T0001，20mg and T0001，35mg
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 1 siteChina
Study dates: Oct 2014to Feb 2015
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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;

Who cannot join

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;

Trial locations and contacts

1 site in 1 country.

China1 site

Phase I laboratory of Peking University People's Hospital
Beijing, Beijing Municipality, 100044

Other trials in China

About this study

Official title: An Open, Dose Escalation, Single Dose Study to Assess Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers

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

Conditions: Rheumatic Diseases
Being tested: T0001，10mg, T0001，20mg, T0001，35mg, T0001，50mg, T0001，65mg
Medical subject headings: Rheumatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

T0001，10mgDrug
T0001，20mgDrug
T0001，35mgDrug
T0001，50mgDrug
T0001，65mgDrug
T0001，75mgDrug

Study groups in NCT02291471
Study group	Role	What they receive
T0001	Experimental	Not described Receives: Drug: T0001，10mg; Drug: T0001，20mg; Drug: T0001，35mg; Drug: T0001，50mg; Drug: T0001，65mg; Drug: T0001，75mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Tolerance Dose
Measured: 3 weeks

Secondary outcomes (2)

Adverse events
Measured: 3 weeks
pharmacokinetics parameter(Cmax, AUC, t1/2, CL, etc）
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Feb 2015

First posted14 Nov 2014 (estimated)
Study startOct 2014
Primary completionFeb 2015
Study completionFeb 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Rheumatic DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02291471
Sponsor's protocol ID: T0001-P1.0
Status last verified: Jul 2019
First submitted: 11 Nov 2014
Last updated: 9 Jul 2019
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rheumatic Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open, Dose Escalation, Single Dose Study to Assess Tolerance and Pharmacokinetics of T0001 in Healthy Adult Chinese Volunteers
ClinicalTrials.gov ID: NCT02291471
Acronym / sponsor ID: T0001-P1.0
Conditions: Rheumatic Diseases
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 14 Nov 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
T0001	Experimental	Drug: T0001，10mg, Drug: T0001，20mg, Drug: T0001，35mg, Drug: T0001，50mg, Drug: T0001，65mg, Drug: T0001，75mg

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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;

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
T0001，10mg	Drug	T0001
T0001，20mg	Drug	T0001
T0001，35mg	Drug	T0001
T0001，50mg	Drug	T0001
T0001，65mg	Drug	T0001
T0001，75mg	Drug	T0001

Primary outcome

Maximum Tolerance Dose
Time frame: 3 weeks

2 secondary outcomes

Adverse events
Time frame: 3 weeks
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.

Related trials for Rheumatic Diseases

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Wang wei study director

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Fang Yi, Ph.D principal investigator

Peking University People's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing T0001，10mg, T0001，20mg and T0001，35mg in people with Rheumatic Diseases, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerance Dose (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02291471.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019.