Allergic RhinitisPhase 1NCT00925678
DSP-3025 Study of Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season
A Phase 1 study testing DSP-3025 in people with Allergic Rhinitis and Healthy Volunteer, run by Sumitomo Pharma Co., Ltd. at 1 site in Japan.
Trial summary
Investigate safety/tolerability after a single dose intranasal administration of DSP-3025 comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients out of season. Read more about this study
- Who is it for?
- Ages 20 to 39 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis, Healthy Volunteer
- What is being tested?
- DSP-3025
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteJapan
- Study dates
- Jun 2009to 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 39 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 18.5 and 25 kg/ m2 and a weight between 50 and 80 kg
- No clinically relevant abnormal findings
- History of cedar and/or Japanese cypress pollen induced seasonal allergic rhinitis for at least the previous 2 years (only Allergic rhinitis)
Who cannot join
- Acute illness which requires medical intervention
- Definite or suspected personal history of adverse drug reactions or drug hypersensitivity
- Clinical relevant disease or disorder (past or present)
- A history of asthma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Placebo-controlled, Randomised Study to Investigate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of DSP-3025 Administered Intranasally to Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season
Investigate safety/tolerability after a single dose intranasal administration of DSP-3025 comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients out of season.
- Conditions
- Allergic Rhinitis, Healthy Volunteer
- Being tested
- DSP-3025, Placebo
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSP-3025Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: DSP-3025 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry
Secondary outcomes (4)
Clinical chemistry, haematology, urinalysis
Nasal symptoms and peak nasal inspiratory flow
Pharmacokinetics
Biomarkers nasal lavage and blood
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies 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
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925678
- Sponsor's protocol ID
- D7002013
- Status last verified
- Apr 2022
- First submitted
- 19 Jun 2009
- Last updated
- 12 Apr 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomised Study to Investigate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of DSP-3025 Administered Intranasally to Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season
- ClinicalTrials.gov ID
- NCT00925678
- Acronym / sponsor ID
- D7002013
- Conditions
- Allergic Rhinitis, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Sumitomo Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2009
- First posted
- 22 Jun 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.
Investigate safety/tolerability after a single dose intranasal administration of DSP-3025 comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients out of season.
Study design
- Allocation
- Randomised
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DSP-3025 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) between 18.5 and 25 kg/ m2 and a weight between 50 and 80 kg
- No clinically relevant abnormal findings
- History of cedar and/or Japanese cypress pollen induced seasonal allergic rhinitis for at least the previous 2 years (only Allergic rhinitis)
Key exclusion criteria (4 listed)
- Acute illness which requires medical intervention
- Definite or suspected personal history of adverse drug reactions or drug hypersensitivity
- Clinical relevant disease or disorder (past or present)
- A history of asthma
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 |
|---|---|---|
| DSP-3025 | Drug | 1 |
| Placebo | Drug | 2 |
Primary outcome
Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry
4 secondary outcomes
Clinical chemistry, haematology, urinalysis
Nasal symptoms and peak nasal inspiratory flow
Pharmacokinetics
Biomarkers nasal lavage and blood
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 12 Apr 2022.
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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.
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 DSP-3025 in people with Allergic Rhinitis and Healthy Volunteer, run by Sumitomo Pharma Co., Ltd. at 1 site in Japan.
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 4 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 12 Apr 2022. 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 Japan. 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?
Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry. 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 12 Apr 2022.