Healthy VolunteersPhase 1NCT00959777
Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating DA-3031 (PEG-G-CSF) to Filgrastim (Dong-A) in Healthy Volunteers
A Phase 1 study testing DA-3031 and Filgrastim in people with Healthy Volunteers, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
Trial summary
The safety, tolerability, and pharmacokinetics(PK)/pharmacodynamics (PD) of DA-3031 (PEG-G-CSF) following a single dose delivered by subcutaneous (SC) injection were investigated in healthy volunteers. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men only
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- DA-3031 and Filgrastim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Start not givento not given
- 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 20 to 40 years
- Men only
- Adult
Who may be able to join
- Healthy males subjects, 20-40 years inclusive
- weight 60-75 kg inclusive and Ideal Body Weight (IBW) between -15% and +15% inclusive
- Written informed consent given
- Willing and able to comply with the requirements of the protocol
Who cannot join
- Hypersensitivity to drugs(aspirin, antibiotics and so on)
- History or presence of any clinically significant liver or kidney disease, gastrointestinal, cardiovascular, respiratory, endocrinal, musculoskeletal, neurologic/psychiatric, hematological, oncological pathology
- Have a history of drug abuse, or show positive for drug abuse at urine screening
- Have participated in another clinical study within 2 months prior to entering inth the study
- Have been persistently drinking alcohol or can not stop drinking alcohol during the study
- Smokers whose average smoke for last 3 months is more than 10 cigarettes/day
- Are considered ineligible by the investigator due to clinical laboratory results or any other relevant reasons
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Clinical Trials center, Clinical Research institute, Seoul National University Hospital
Seoul, Yonggon-Dong, Chongono-Gu, 110-744
About this study
The safety, tolerability, and pharmacokinetics(PK)/pharmacodynamics (PD) of DA-3031 (PEG-G-CSF) following a single dose delivered by subcutaneous (SC) injection were investigated in healthy volunteers. PK/PD of filgrastim (Dong-A) following repeated dose delivered by SC injection were investigated in healthy volunteers. PK/PD from a single dose of DA-3031 and repeated dose of filgrastim (Dong-A) were compared.
- Conditions
- Healthy Volunteers
- Being tested
- DA-3031, Filgrastim
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DA-3031Drug
FilgrastimDrug
| Study group | Role | What they receive |
|---|---|---|
| DA-3031 | Experimental | Not described Receives: Drug: DA-3031 |
| filgrastim | Active comparator | Not described Receives: Drug: Filgrastim |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
Sponsor and investigators
- Lead sponsor
- Dong-A ST Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959777
- Sponsor's protocol ID
- DA3031_NP_I
- Status last verified
- Sep 2014
- First submitted
- 13 Aug 2009
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee S, Hong KT, Jang IJ, Yu KS, Kang HJ, Oh J. Semimechanistic pharmacokinetic-pharmacodynamic model of tripegfilgrastim for pediatric patients after chemotherapy. CPT Pharmacometrics Syst Pharmacol. 2023 Sep;12(9):1319-1334. doi: 10.1002/psp4.13012. Epub 2023 Aug 9.
PubMed 37559343Ahn LY, Shin KH, Lim KS, Kim TE, Jeon H, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Relationship between absolute neutrophil count profiles and pharmacokinetics of DA-3031, a pegylated granulocyte colony-stimulating factor (pegylated-G-CSF): a dose block-randomized, double-blind, dose-escalation study in healthy subjects. Clin Drug Investig. 2013 Nov;33(11):817-24. doi: 10.1007/s40261-013-0130-9.
PubMed 24078278
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic/Pharmacodynamic (PK/PD) Study Evaluating DA-3031 (PEG-G-CSF) to Filgrastim (Dong-A) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00959777
- Acronym / sponsor ID
- DA3031_NP_I
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Dong-A ST Co., Ltd.Industry (pharma, biotech, devices)
- First posted
- 17 Aug 2009 (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 safety, tolerability, and pharmacokinetics(PK)/pharmacodynamics (PD) of DA-3031 (PEG-G-CSF) following a single dose delivered by subcutaneous (SC) injection were investigated in healthy volunteers. PK/PD of filgrastim (Dong-A) following repeated dose delivered by SC injection were investigated in healthy volunteers. PK/PD from a single dose of DA-3031 and repeated dose of filgrastim (Dong-A) were compared.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DA-3031 | Experimental | Drug: DA-3031 |
| filgrastim | Active comparator | Drug: Filgrastim |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males subjects, 20-40 years inclusive
- weight 60-75 kg inclusive and Ideal Body Weight (IBW) between -15% and +15% inclusive
- Written informed consent given
- Willing and able to comply with the requirements of the protocol
Key exclusion criteria (7 listed)
- Hypersensitivity to drugs(aspirin, antibiotics and so on)
- History or presence of any clinically significant liver or kidney disease, gastrointestinal, cardiovascular, respiratory, endocrinal, musculoskeletal, neurologic/psychiatric, hematological, oncological pathology
- Have a history of drug abuse, or show positive for drug abuse at urine screening
- Have participated in another clinical study within 2 months prior to entering inth the study
- Have been persistently drinking alcohol or can not stop drinking alcohol during the study
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 |
|---|---|---|
| DA-3031 | Drug | DA-3031 |
| Filgrastim | Drug | filgrastim |
Primary outcome
Not reported in the source record.
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 1 Oct 2014.
- Derived from this study: PubMed 37559343Lee S, Hong KT, Jang IJ, Yu KS, Kang HJ, Oh J. Semimechanistic pharmacokinetic-pharmacodynamic model of tripegfilgrastim for pediatric patients after chemotherapy. CPT Pharmacometrics Syst Pharmacol. 2023 Sep;12(9):1319-1334. doi: 10.1002/psp4.13012. Epub 2023 Aug 9.
- Derived from this study: PubMed 24078278Ahn LY, Shin KH, Lim KS, Kim TE, Jeon H, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Relationship between absolute neutrophil count profiles and pharmacokinetics of DA-3031, a pegylated granulocyte colony-stimulating factor (pegylated-G-CSF): a dose block-randomized, double-blind, dose-escalation study in healthy subjects. Clin Drug Investig. 2013 Nov;33(11):817-24. doi: 10.1007/s40261-013-0130-9.
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Healthy Participants
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.
The record lists no contact. Use the official record to reach the sponsor.
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 DA-3031 and Filgrastim in people with Healthy Volunteers, run by Dong-A ST Co., Ltd. at 1 site in South Korea.
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 4 inclusion and 7 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 1 Oct 2014. 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 South Korea. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00959777, which also lists 2 linked publications.
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 1 Oct 2014.