HealthyPhase 1NCT01481597
Deuteporfin Tolerance and Pharmacokinetics in Healthy Volunteers
A Phase 1 study testing deuteporfin in people with Healthy, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
Deuteporfin, a novel photodynamic drug developed in China, displays good photodynamic antitumor activity. The purpose of the present study is to investigate the safety and pharmacokinetics of intravenous deuteporfin in healthy Chinese volunteers following single-dose administration. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- deuteporfin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- Nov 2011to Apr 2012
- 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
- Chinese healthy male and/or female subjects
- 18 to 45 years old with Body mass index (BMI) within the range of 19 to 24 kg/m2
- weigh at least 45 kg for female subjects or 50 kg for male subjects
- In good health as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Who cannot join
- Significant illness or major surgery within four weeks prior to dosing
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and photoallergy)
- Use of any drugs which might interfere with drug absorption, distribution, metabolism, excretion or cause photoallergy within 30 days prior to dosing, or any drugs within 14 days prior to dosing
- Participation in any clinical investigation within 30 days prior to dosing
- Smokers, alcoholics, drug abusers
- Immunodeficiency diseases, including a positive HIV test result, Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result
- pregnancy or lactation for female subjects
Trial locations and contacts
1 site in 1 country.
China1 site
Xiangya Hospital of Central-South University
Changsha, Hunan, 410008
About this study
Official title: Tolerance and Pharmacokinetics of Single-dose Intravenous Deuteporfin in Healthy Volunteers
Deuteporfin, a novel photodynamic drug developed in China, displays good photodynamic antitumor activity. The purpose of the present study is to investigate the safety and pharmacokinetics of intravenous deuteporfin in healthy Chinese volunteers following single-dose administration.
- Conditions
- Healthy
- Being tested
- deuteporfin, placebo
- Keywords
- deuteporfin, safety, tolerability, pharmacokinetics, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deuteporfinDrug
deuteporfin 1 mg/kg IV as a single dose
deuteporfinDrug
deuteporfin 2.5 mg/kg IV as a single dose
deuteporfinDrug
deuteporfin 5 mg/kg IV as a single dose
deuteporfinDrug
deuteporfin 7.5 mg/kg IV as a single dose
placeboDrug
Placebo for 2.5 mg/kg, 5 mg/kg and 7.5mg/kg of deuteporfin (single dose)
| Study group | Role | What they receive |
|---|---|---|
| deuteporfin 1mg/kg | Experimental | Not described Receives: Drug: deuteporfin |
| deuteporfin 2.5mg/kg | Active comparator | Not described Receives: Drug: deuteporfin |
| deuteporfin 5mg/kg | Active comparator | Not described Receives: Drug: deuteporfin |
| deuteporfin 7.5mg/kg | Active comparator | Not described Receives: Drug: deuteporfin |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with adverse events
number of participants with adverse events as a measure of safety and tolerability of single dose of deuteporfin administered to healthy subjects
Measured: up to 19 days following injection
Secondary outcomes (1)
Pharmacokinetic profile
Pharmacokinetic profile: Cmax (Peak Concentration), AUC (area under the plasma-concentration-time curve ), T1/2 (half life)
Measured: predose, 20, 40 and 60 min during-dose, and 5, 10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8 ,12, 24h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zeneng Cheng, Ph.D, Principal investigator, Xiangya Hospital of Central South UniversityJining Tao, Master, Study director, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.Pingsheng Xu, Master, Principal investigator, Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481597
- Sponsor's protocol ID
- FDZJ1109DT
- Status last verified
- May 2012
- First submitted
- 10 Oct 2011
- Last updated
- 16 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Pharmacokinetics of Single-dose Intravenous Deuteporfin in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01481597
- Acronym / sponsor ID
- FDZJ1109DT
- Conditions
- Healthy
- Keywords
- deuteporfin, safety, tolerability, pharmacokinetics, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 29 Nov 2011 (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.
Deuteporfin, a novel photodynamic drug developed in China, displays good photodynamic antitumor activity. The purpose of the present study is to investigate the safety and pharmacokinetics of intravenous deuteporfin in healthy Chinese volunteers following single-dose administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| deuteporfin 1mg/kg | Experimental | Drug: deuteporfin |
| deuteporfin 2.5mg/kg | Active comparator | Drug: deuteporfin |
| deuteporfin 5mg/kg | Active comparator | Drug: deuteporfin |
| deuteporfin 7.5mg/kg | Active comparator | Drug: deuteporfin |
| placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Chinese healthy male and/or female subjects
- 18 to 45 years old with Body mass index (BMI) within the range of 19 to 24 kg/m2
- weigh at least 45 kg for female subjects or 50 kg for male subjects
- In good health as confirmed by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis on the screening and baseline evaluation
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
Key exclusion criteria (7 listed)
- Significant illness or major surgery within four weeks prior to dosing
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and photoallergy)
- Use of any drugs which might interfere with drug absorption, distribution, metabolism, excretion or cause photoallergy within 30 days prior to dosing, or any drugs within 14 days prior to dosing
- Participation in any clinical investigation within 30 days prior to dosing
- Smokers, alcoholics, drug abusers
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 |
|---|---|---|
| deuteporfindeuteporfin 1 mg/kg IV as a single dose | Drug | deuteporfin 1mg/kg |
| deuteporfindeuteporfin 2.5 mg/kg IV as a single dose | Drug | deuteporfin 2.5mg/kg |
| deuteporfindeuteporfin 5 mg/kg IV as a single dose | Drug | deuteporfin 5mg/kg |
| deuteporfindeuteporfin 7.5 mg/kg IV as a single dose | Drug | deuteporfin 7.5mg/kg |
| placeboPlacebo for 2.5 mg/kg, 5 mg/kg and 7.5mg/kg of deuteporfin (single dose) | Drug | placebo |
Primary outcome
number of participants with adverse events
Time frame: up to 19 days following injection
number of participants with adverse events as a measure of safety and tolerability of single dose of deuteporfin administered to healthy subjects
1 secondary outcome
Pharmacokinetic profile
Time frame: predose, 20, 40 and 60 min during-dose, and 5, 10, 20, 40 min and 1, 1.5, 2, 3, 4, 6, 8 ,12, 24h post-dose
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 16 May 2012.
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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.
Zeneng Cheng, Ph.D principal investigator
Xiangya Hospital of Central South University
Jining Tao, Master study director
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Pingsheng Xu, Master principal investigator
Xiangya Hospital of Central South University
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 deuteporfin in people with Healthy, 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 5 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 16 May 2012. 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. Some participants in this study may receive a placebo. 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 adverse events (time frame: up to 19 days following injection). 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 16 May 2012.