Healthy VolunteersPhase 1NCT02134834
A Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of OP0595
A Phase 1 study testing OP0595 in people with Healthy Volunteers and Bacterial Infections, run by Meiji Seika Pharma Co., Ltd. at 1 site in Australia.
Trial summary
The objectives of this study are to assess the safety, tolerability and pharmacokinetic profile of OP0595 administered intravenously to healthy male, Caucasian, adult subjects at single escalating doses. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Bacterial Infections
- What is being tested?
- OP0595
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- May 2014to Nov 2014
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian males aged between 18 and 45 years (inclusive) at Screening
- A Body Mass Index (BMI) between 18.0 and 30.0 kg/m² (inclusive) at Screening
- Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests
- Negative urine test for drugs of abuse and breath test for alcohol both at Screening and Day -1
Who cannot join
- Receipt of any investigational agent or drug within four months before Screening
- A history or current evidence of allergic symptoms such as bronchial asthma, drug-induced rash or urticaria
- Hypersensitivity and/or allergy to drugs
- Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders
- A history of chronic or recurrent infections or current active infection
- A recent history of surgery within three months prior to Screening, determined by the Investigator to be clinically relevant
Show all 9Show fewer
- A history or presence of malignancy
- Donation of blood (or loss of blood) greater than 400 ml within three months before Screening
- A history of smoking at any time within one year before Screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of OP0595 Administered Intravenously in Healthy Male Subjects.
The objectives of this study are to assess the safety, tolerability and pharmacokinetic profile of OP0595 administered intravenously to healthy male, Caucasian, adult subjects at single escalating doses.
- Conditions
- Healthy Volunteers, Bacterial Infections
- Being tested
- OP0595, Placebo
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OP0595Drug
Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation
PlaceboDrug
Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation
| Study group | Role | What they receive |
|---|---|---|
| Ascending single dose of OP0595 | Experimental | Not described Receives: Drug: OP0595 |
| Normal Saline | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety from baseline through the end of the study
Number of patients with adverse events
Measured: Day 1 to Day 7
Secondary outcomes (2)
Plasma PK parameters of OP0595 and its metabolites
Cmax, tmax, AUC0-last, AUC0-inf, Kel, T1/2, CLtot, Vdss
Measured: Day 1 to Day 2
Urine PK parameters of OP0595 and its metabolites
Ae, Ae0-t, Ae0-t/Dose, CLr
Measured: Day 1 to Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2014
- Study completionNov 2014
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 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meiji Seika Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitsuharu Egawa, Study chair, Meiji Seika Pharma Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134834
- Sponsor's protocol ID
- OP0595-1
- Status last verified
- Dec 2014
- First submitted
- 7 May 2014
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mallalieu NL, Winter E, Fettner S, Patel K, Zwanziger E, Attley G, Rodriguez I, Kano A, Salama SM, Bentley D, Geretti AM. Safety and Pharmacokinetic Characterization of Nacubactam, a Novel beta-Lactamase Inhibitor, Alone and in Combination with Meropenem, in Healthy Volunteers. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02229-19. doi: 10.1128/AAC.02229-19. Print 2020 Apr 21.
PubMed 32041717
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of OP0595 Administered Intravenously in Healthy Male Subjects.
- ClinicalTrials.gov ID
- NCT02134834
- Acronym / sponsor ID
- OP0595-1
- Conditions
- Healthy Volunteers, Bacterial Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Meiji Seika Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 9 May 2014 (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 objectives of this study are to assess the safety, tolerability and pharmacokinetic profile of OP0595 administered intravenously to healthy male, Caucasian, adult subjects at single escalating doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ascending single dose of OP0595 | Experimental | Drug: OP0595 |
| Normal Saline | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Caucasian males aged between 18 and 45 years (inclusive) at Screening
- A Body Mass Index (BMI) between 18.0 and 30.0 kg/m² (inclusive) at Screening
- Good general health as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead ECG and clinical laboratory tests
- Negative urine test for drugs of abuse and breath test for alcohol both at Screening and Day -1
Key exclusion criteria (9 listed)
- Receipt of any investigational agent or drug within four months before Screening
- A history or current evidence of allergic symptoms such as bronchial asthma, drug-induced rash or urticaria
- Hypersensitivity and/or allergy to drugs
- Concurrent or history of clinically significant cardiovascular, hepatic, renal, endocrine, gastrointestinal, respiratory, psychiatric, neurologic and/or hematological disorders
- A history of chronic or recurrent infections or current active infection
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 |
|---|---|---|
| OP0595Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation | Drug | Ascending single dose of OP0595 |
| PlaceboFive cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation | Drug | Normal Saline |
Primary outcome
Safety from baseline through the end of the study
Time frame: Day 1 to Day 7
Number of patients with adverse events
2 secondary outcomes
Plasma PK parameters of OP0595 and its metabolites
Time frame: Day 1 to Day 2
Urine PK parameters of OP0595 and its metabolites
Time frame: Day 1 to Day 2
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 Dec 2014.
- Derived from this study: PubMed 32041717Mallalieu NL, Winter E, Fettner S, Patel K, Zwanziger E, Attley G, Rodriguez I, Kano A, Salama SM, Bentley D, Geretti AM. Safety and Pharmacokinetic Characterization of Nacubactam, a Novel beta-Lactamase Inhibitor, Alone and in Combination with Meropenem, in Healthy Volunteers. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02229-19. doi: 10.1128/AAC.02229-19. Print 2020 Apr 21.
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Mitsuharu Egawa study chair
Meiji Seika Pharma 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 OP0595 in people with Healthy Volunteers and Bacterial Infections, run by Meiji Seika Pharma Co., Ltd. at 1 site in Australia.
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 9 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 Dec 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 Australia. 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?
Safety from baseline through the end of the study (time frame: Day 1 to Day 7). 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 NCT02134834, 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 12 Dec 2014.