Healthy Adult SubjectsPhase 1NCT01508988
Single Dose Escalation Study of ONO-9054 in Healthy Volunteers
A Phase 1 study testing ONO-9054 in people with Healthy Adult Subjects, run by Ono Pharma USA Inc at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate the safety and tolerability of ascending single doses of ONO-9054 administered as a single drop in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to evaluate the… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- ONO-9054
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female subjects, aged 18-64 inclusive
- Body mass index (BMI) of 19-35 kg/m2 (inclusive)
- IOP measurement oculus uterque (OU, both eyes) < 21 mm Hg (inclusive) at screening and Day -1
- Best corrected visual acuity (BCVA) 20/30 or better (Snellen Equivalent) at both the screening visit and Day -1
Who cannot join
- Any history of severe ocular trauma in either eye at any time
- Any history of previous intraocular or ocular laser surgery within the past 3 months or any refractive surgery procedure within the past 6 months of the screening visit in either eye
- Current or chronic history of ocular infection within the past 3 months of screening visit in either eye OR ongoing or recurrent ocular inflammation in either eye
- At the ophthalmic investigator's discretion, any subjects who have a history of any significant ocular conditions in either eye that would contraindicate the use of the study medication, or that might affect the study conduct, or the interpretation of the study results
- Use of any non-diagnostic topical ophthalmic solutions except for sponsor-recommended tear substitutes from admission to the study unit through the duration of the study
- History of clinically significant drug or food allergy, positive HIV, hepatitis B or C at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-masked Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ONO-9054 in Healthy Adult Subjects
The primary objective of this study is to evaluate the safety and tolerability of ascending single doses of ONO-9054 administered as a single drop in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to evaluate the pharmacodynamic (PD) profile.
- Conditions
- Healthy Adult Subjects
- Being tested
- ONO-9054
- Keywords
- ONO-9054, adult healthy volunteers, single dose, phase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-9054Drug
Eye drops 0.3 µg/mL both eyes on Day one
ONO-9054Drug
Eye drops 1 µg/mL both eyes on Day one
ONO-9054Drug
Eye drops 3 µg/mL both eyes on Day one
ONO-9054Drug
Eye drops 10 µg/mL both eyes on Day one
ONO-9054Drug
Eye drops 20 µg/mL both eyes on Day one
ONO-9054Drug
Eye drops 30 µg/mL both eyes on Day one
ONO-9054Drug
Matched-placebo eye drops dosed in the same manner as ONO-9054 in both eyes on Day one
| Study group | Role | What they receive |
|---|---|---|
| Eye drops 0.3 µg/mL | Experimental | Not described Receives: Drug: ONO-9054 |
| Eye drops 1 µg/mL | Experimental | Not described Receives: Drug: ONO-9054 |
| Eye drops 3 µg/mL | Experimental | Not described Receives: Drug: ONO-9054 |
| Eye drops 10 µg/mL | Experimental | Not described Receives: Drug: ONO-9054 |
| Eye drops 20 µg/mL | Experimental | Not described Receives: Drug: ONO-9054 |
| Eye drops 30 µg/mL | Experimental | Not described Receives: Drug: ONO-9054 |
| Eye drops placebo | Experimental | Not described Receives: Drug: ONO-9054 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of ONO-9054 using vital signs, ECGs, laboratory tests, ocular exams, spirometry, physical examinations and incidence/severity of adverse events
Measured: up to 4 days
Secondary outcomes (2)
1. Characterization of PK profiles of ONO-9054 and metabolite through measurement of drug concentration in plasma sample
Measured: up to 2 days
2. Pharmacodynamic evaluation of ophthalmic effects by measuring the degree and duration of intraocular pressure lowering
Measured: up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy Adult SubjectsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharma USA Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ono Pharma USA, Inc., Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508988
- Sponsor's protocol ID
- ONO-9054IOU001
- Status last verified
- Jun 2012
- First submitted
- 9 Jan 2012
- Last updated
- 14 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Suto F, Rowe-Rendleman CL, Ouchi T, Jamil A, Wood A, Ward CL. A Novel Dual Agonist of EP3 and FP Receptors for OAG and OHT: Safety, Pharmacokinetics, and Pharmacodynamics of ONO-9054 in Healthy Volunteers. Invest Ophthalmol Vis Sci. 2015 Dec;56(13):7963-70. doi: 10.1167/iovs.15-18166.
PubMed 26720443
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-masked Placebo-controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ONO-9054 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01508988
- Acronym / sponsor ID
- ONO-9054IOU001
- Conditions
- Healthy Adult Subjects
- Keywords
- ONO-9054, adult healthy volunteers, single dose, phase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ono Pharma USA IncIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Apr 2012 (actual)
- First posted
- 12 Jan 2012 (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 primary objective of this study is to evaluate the safety and tolerability of ascending single doses of ONO-9054 administered as a single drop in healthy adult subjects. The secondary objectives are to characterize the pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to evaluate the pharmacodynamic (PD) profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Eye drops 0.3 µg/mL | Experimental | Drug: ONO-9054 |
| Eye drops 1 µg/mL | Experimental | Drug: ONO-9054 |
| Eye drops 3 µg/mL | Experimental | Drug: ONO-9054 |
| Eye drops 10 µg/mL | Experimental | Drug: ONO-9054 |
| Eye drops 20 µg/mL | Experimental | Drug: ONO-9054 |
| Eye drops 30 µg/mL | Experimental | Drug: ONO-9054 |
| Eye drops placebo | Experimental | Drug: ONO-9054 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female subjects, aged 18-64 inclusive
- Body mass index (BMI) of 19-35 kg/m2 (inclusive)
- IOP measurement oculus uterque (OU, both eyes) < 21 mm Hg (inclusive) at screening and Day -1
- Best corrected visual acuity (BCVA) 20/30 or better (Snellen Equivalent) at both the screening visit and Day -1
Key exclusion criteria (6 listed)
- Any history of severe ocular trauma in either eye at any time
- Any history of previous intraocular or ocular laser surgery within the past 3 months or any refractive surgery procedure within the past 6 months of the screening visit in either eye
- Current or chronic history of ocular infection within the past 3 months of screening visit in either eye OR ongoing or recurrent ocular inflammation in either eye
- At the ophthalmic investigator's discretion, any subjects who have a history of any significant ocular conditions in either eye that would contraindicate the use of the study medication, or that might affect the study conduct, or the interpretation of the study results
- Use of any non-diagnostic topical ophthalmic solutions except for sponsor-recommended tear substitutes from admission to the study unit through the duration of 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 |
|---|---|---|
| ONO-9054Eye drops 0.3 µg/mL both eyes on Day one | Drug | Eye drops 0.3 µg/mL |
| ONO-9054Eye drops 1 µg/mL both eyes on Day one | Drug | Eye drops 1 µg/mL |
| ONO-9054Eye drops 3 µg/mL both eyes on Day one | Drug | Eye drops 3 µg/mL |
| ONO-9054Eye drops 10 µg/mL both eyes on Day one | Drug | Eye drops 10 µg/mL |
| ONO-9054Eye drops 20 µg/mL both eyes on Day one | Drug | Eye drops 20 µg/mL |
| ONO-9054Eye drops 30 µg/mL both eyes on Day one | Drug | Eye drops 30 µg/mL |
| ONO-9054Matched-placebo eye drops dosed in the same manner as ONO-9054 in both eyes on Day one | Drug | Eye drops placebo |
Primary outcome
Safety and tolerability of ONO-9054 using vital signs, ECGs, laboratory tests, ocular exams, spirometry, physical examinations and incidence/severity of adverse events
Time frame: up to 4 days
2 secondary outcomes
1. Characterization of PK profiles of ONO-9054 and metabolite through measurement of drug concentration in plasma sample
Time frame: up to 2 days
2. Pharmacodynamic evaluation of ophthalmic effects by measuring the degree and duration of intraocular pressure lowering
Time frame: up to 2 days
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 14 Jun 2012.
- Derived from this study: PubMed 26720443Suto F, Rowe-Rendleman CL, Ouchi T, Jamil A, Wood A, Ward CL. A Novel Dual Agonist of EP3 and FP Receptors for OAG and OHT: Safety, Pharmacokinetics, and Pharmacodynamics of ONO-9054 in Healthy Volunteers. Invest Ophthalmol Vis Sci. 2015 Dec;56(13):7963-70. doi: 10.1167/iovs.15-18166.
Related trials for Healthy Adult Subjects
Not yet recruiting
Acute Effects of High-Intensity Laser Therapy on Pain, Muscle Stiffness, and Grip Strength in Healthy Adults
Exercise-Induced Muscle Fatigue, Fatigue Recovery
RecruitingPhase 1
PET Imaging of the sigma1 Receptor in Healthy Adults
Healthy Control Subjects
RecruitingPhase 1
Phase Ia Study of MST-931 in Healthy Adult Subjects
Ankylosing Spondylitis (AS)
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingPhase 1
A Single Ascending Dose, and Food Effect Study of ABBV-7828 in Healthy Adults
Healthy Subjects
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.
Ono Pharma USA, Inc. study director
Ono Pharmaceutical Co., Ltd.
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 ONO-9054 in people with Healthy Adult Subjects, run by Ono Pharma USA Inc at 1 site in United States.
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 6 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 14 Jun 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 United States. 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?
Safety and tolerability of ONO-9054 using vital signs, ECGs, laboratory tests, ocular exams, spirometry, physical examinations and incidence/severity of adverse events (time frame: up to 4 days). 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 NCT01508988, which also lists 1 linked publication.
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 14 Jun 2012.