Chemotherapy-induced NeutropeniaPhase 1NCT02643901
Tolerability and Pharmacokinetics(PK)/Pharmacodynamics(PD) Study of GW003 in Healthy Subjects
A Phase 1 study testing GW003 in people with Chemotherapy-induced Neutropenia, run by Jiangsu T-Mab Biopharma Co.,Ltd at 1 site in China.
Trial summary
This study is designed to access the tolerability and Pharmacokinetic/Pharmacodynamic (PK/PD) of single subcutaneous (SC) injection of GW003 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-induced Neutropenia
- What is being tested?
- GW003
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to 10 Oct 2016
- 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
- 18 years to 45 years,Healthy male and female subjects.in the same dose group,the age difference between in 10 years
- At least 50kg weight,BMI between 19 and 25kg/m2
- No tobacco, alcohol and other bad habits
- No history of drug allergy and biological agents allergy and other allergies
- Not used biological agents and other drugs within three months before participated in this test
- Not participated in other test or donated blood within three months before participated in this test
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- The medical history、physical examination、laboratory examination is normal or slightly abnormal
- Subjects can obey the clinical trial protocol
- Subjects, who are willing to follow the study protocol and provide written informed consent voluntarily.
Who cannot join
- History of severe system disease(especially with the spleen swelling, adult respiratory distress syndrome and exudative pneumonia or sickle red blood cell anemia history)
- History of drug allergy and biological agents allergy and other allergies
- Subjects have used any long discharge period drugs will affect the present study within 3 months or are using drugs now
- Subjects not to take effective contraceptive measures or have a family planning within one year， Pregnancy or nursing women
- Subjects accepted major surgery 4 weeks before drug administration
- Subjects vaccinated live vaccine 3 months before drug administration
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- Subjects with the history of drug abuse 5 years before drug administration
- As the subjects participated 3 times or more than 3 times drug clinical trials within 1 year or as the subjects participated any drug clinical trial or donated blood within 3 months
- Clinical and laboratory examination results is abnormal and have clinical significance
- Subjects with poor compliance or have any unfavorable factors to participate in this test
- Subjects can not complete the research
- The researchers and their family members.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Single-Dose Tolerability and PK/PD Study of Recombinant (Expressed by Pichia Pastoris) Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor(I) Fusion Protein for Injection (GW003) in Healthy Subjects
This study is designed to access the tolerability and Pharmacokinetic/Pharmacodynamic (PK/PD) of single subcutaneous (SC) injection of GW003 in healthy subjects.
- Conditions
- Chemotherapy-induced Neutropenia
- Being tested
- GW003
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW003Biological
single SC injection
| Study group | Role | What they receive |
|---|---|---|
| Ic-GW003 150ug/kg 4-8subjects | Experimental | Biological/Vaccine:GW003 freeze-dried powder single SC injection Receives: Biological: GW003 |
| Ic-GW003 300ug/kg 6-8subjects | Experimental | Biological/Vaccine:GW003 freeze-dried powder single SC injection Receives: Biological: GW003 |
| Ic-GW003 500ug/kg 6-8subjects | Experimental | Biological/Vaccine:GW003 freeze-dried powder single SC injection Receives: Biological: GW003 |
| Ic-GW003 650ug/kg 6-8subjects | Experimental | Biological/Vaccine:GW003 freeze-dried powder single SC injection Receives: Biological: GW003 |
| Ic-GW003 850ug/kg 6-8subjects | Experimental | Biological/Vaccine:GW003 freeze-dried powder single SC injection Receives: Biological: GW003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To evaluate the safety and tolerance of single SC injection of GW003 in healthy subjects.
Measured: up to day 21
Secondary outcomes (3)
Frequency of subjects with Anti-GW003 antibody
anti-GW003 was detected pre-dose and at the last visit,if there exist positive anti-GW003 antibody, another detected should be conducted 6 months after the trial.
Measured: up to 6 months after the trial
half-life(consist of distribution and elimination half-life) for GW003
Measured: up to day 14
area under the concentration-time curve(AUC) for GW003
Measured: up to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2015 (estimated)
- Study startSep 2015
- Primary completion10 Oct 2016
- Study completion10 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced NeutropeniaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu T-Mab Biopharma Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Qi Junyuan, doctor, Principal investigator, Tianjin Hematonosis Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02643901
- Sponsor's protocol ID
- Tmab-GW003-NP-03
- Status last verified
- Sep 2016
- First submitted
- 30 Nov 2015
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Single-Dose Tolerability and PK/PD Study of Recombinant (Expressed by Pichia Pastoris) Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor(I) Fusion Protein for Injection (GW003) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02643901
- Acronym / sponsor ID
- Tmab-GW003-NP-03
- Conditions
- Chemotherapy-induced Neutropenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Jiangsu T-Mab Biopharma Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- 10 Oct 2016 (actual)
- Study completion
- 10 Oct 2016 (actual)
- First posted
- 31 Dec 2015 (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.
This study is designed to access the tolerability and Pharmacokinetic/Pharmacodynamic (PK/PD) of single subcutaneous (SC) injection of GW003 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ic-GW003 150ug/kg 4-8subjects | Experimental | Biological: GW003Biological/Vaccine:GW003 freeze-dried powder single SC injection |
| Ic-GW003 300ug/kg 6-8subjects | Experimental | Biological: GW003Biological/Vaccine:GW003 freeze-dried powder single SC injection |
| Ic-GW003 500ug/kg 6-8subjects | Experimental | Biological: GW003Biological/Vaccine:GW003 freeze-dried powder single SC injection |
| Ic-GW003 650ug/kg 6-8subjects | Experimental | Biological: GW003Biological/Vaccine:GW003 freeze-dried powder single SC injection |
| Ic-GW003 850ug/kg 6-8subjects | Experimental | Biological: GW003Biological/Vaccine:GW003 freeze-dried powder single SC injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 18 years to 45 years,Healthy male and female subjects.in the same dose group,the age difference between in 10 years
- At least 50kg weight,BMI between 19 and 25kg/m2
- No tobacco, alcohol and other bad habits
- No history of drug allergy and biological agents allergy and other allergies
- Not used biological agents and other drugs within three months before participated in this test
Key exclusion criteria (12 listed)
- History of severe system disease(especially with the spleen swelling, adult respiratory distress syndrome and exudative pneumonia or sickle red blood cell anemia history)
- History of drug allergy and biological agents allergy and other allergies
- Subjects have used any long discharge period drugs will affect the present study within 3 months or are using drugs now
- Subjects not to take effective contraceptive measures or have a family planning within one year， Pregnancy or nursing women
- Subjects accepted major surgery 4 weeks before drug administration
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 |
|---|---|---|
| GW003single SC injection | Biological | Ic-GW003 150ug/kg 4-8subjects, Ic-GW003 300ug/kg 6-8subjects, Ic-GW003 500ug/kg 6-8subjects, Ic-GW003 650ug/kg 6-8subjects, Ic-GW003 850ug/kg 6-8subjects |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to day 21
To evaluate the safety and tolerance of single SC injection of GW003 in healthy subjects.
3 secondary outcomes
Frequency of subjects with Anti-GW003 antibody
Time frame: up to 6 months after the trial
half-life(consist of distribution and elimination half-life) for GW003
Time frame: up to day 14
area under the concentration-time curve(AUC) for GW003
Time frame: up to day 14
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 18 Aug 2017.
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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.
Qi Junyuan, doctor principal investigator
Tianjin Hematonosis 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 GW003 in people with Chemotherapy-induced Neutropenia, run by Jiangsu T-Mab Biopharma 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 9 inclusion and 12 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 18 Aug 2017. 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?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: up to day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2017.