Healthy VolunteersPhase 1NCT04079062
Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects
A Phase 1 study testing ONO-4685, KLH and KLH, ONO-4685 in people with Healthy Volunteers, run by Ono Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity in Japanese and Caucasian healthy adult male subjects when ONO-4685 is administered as a single-dose by intravenous infusion. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- ONO-4685, KLH and KLH, ONO-4685
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteJapan
- Study dates
- 12 Sep 2019to 25 May 2021
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese healthy adult male subjects (PartA, B, and C)
- Caucasian healthy adult male subjects (Part D)
- Age (at the time of informed consent): ≥20 yeas, ≤ 45 yeas
- Body weight (at the time of screening test): ≥50 kg
Who cannot join
- Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease.
- Subjects with current or with a history of severe allergy to drugs or foods
- Subjects with current or with a history of drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
About this study
To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity in Japanese and Caucasian healthy adult male subjects when ONO-4685 is administered as a single-dose by intravenous infusion.
Read the detailed description
To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity when ONO-4685 is administered by single-dose intravenous continuous infusion in Japanese and Caucasian healthy adult male subjects. In addition, in Japanese healthy adult male subjects, to investigate dosing condition of Keyhole limpet hemocyanin (KLH) and to investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity when ONO-4685 is administered by single-dose intravenous continuous infusion after treating with KLH.
- Conditions
- Healthy Volunteers
- Being tested
- ONO-4685, Placebo, KLH, KLH, ONO-4685, KLH, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-4685Biological
Single ascending dose of ONO-4685 will be administered by intravenous continuous infusion at the designated speed.
PlaceboBiological
Placebo will be administered by intravenous continuous infusion at the designated speed.
KLHBiological
KLH 1 mg per dose will be subcutaneously administered. In addition, all subjects will be administered placebo after KLH administration.
KLH, ONO-4685Biological
Part C will be conducted in a study design that ONO-4685 will be administered within the dose range, for which the safety has been confirmed in Part A, after administering KLH in the dose regimens selected according to the investigation result in Part B.
KLH, placeboBiological
Part C will be conducted in a study design that placebo will be administered within the dose range, for which the safety has been confirmed in Part A, after administering KLH in the dose resimens selected according to the investigation result in Part B.
| Study group | Role | What they receive |
|---|---|---|
| ONO-4685 (PartA, D) | Experimental | Not described Receives: Biological: ONO-4685 |
| Placebo (PartA, D) | Placebo comparator | Not described Receives: Biological: Placebo |
| KLH+placebo (Part B) | Experimental | Not described Receives: Biological: KLH |
| KLH+ONO-4685 (PartC) | Experimental | Not described Receives: Biological: KLH, ONO-4685 |
| KLH+placebo (PartC) | Experimental | Not described Receives: Biological: KLH, placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events [Safety and Tolerability]
Number of participants with adverse events as assessed by CTCAE v5.0
Measured: Up to 84 days
Vital sign [Safety and Tolerability]
Summary statistics of blood pressure/pulse rate, respiratory rate, SpO2
Measured: Up to 84 days
Body temperature [Safety and Tolerability]
Summary statistics of body temperature
Measured: Up to 84 days
Body weight [Safety and Tolerability]
Summary statistics of body weight
Measured: Up to 84 days
ECG parameter test [Safety and Tolerability]
Summary statistics of ECG parameter test (Heart Rate, RR, PR, QRS, QT, and QTcF)
Measured: Up to 84 days
Laboratory test [Safety and Tolerability]
Summary statistics of laboratory test (hematologic test, blood biochemistry test, blood coagulation test, immunoserologic test urinalysis)
Measured: Up to 84 days
Secondary outcomes (10)
Cmax [Pharmacokinetic] (PartA, C, and D)
Assessment of the Cmax of ONO-4685
Measured: Up to 84 days
Tmax [Pharmacokinetic] (PartA, C, and D)
Assessment of the Tmax of ONO-4685
Measured: Up to 84 days
AUC [Pharmacokinetic] (PartA, C, and D)
Assessment of the AUC168h, AUClast, and AUCinf of ONO-4685
Measured: Up to 84 days
T1/2 [Pharmacokinetic] (PartA, C, and D)
Assessment of the T1/2 of ONO-4685
Measured: Up to 84 days
CL [Pharmacokinetic] (PartA, C, and D)
Assessment of the CL of ONO-4685
Measured: Up to 84 days
Vss [Pharmacokinetic] (PartA, C, and D)
Assessment of the Vss of ONO-4685
Measured: Up to 84 days
Serum cytokine concentration [Pharmacodynamics] (PartA, C, and D)
Serum cytokine concentration
Measured: Up to 84 days
Hemocyte test [Pharmacodynamics] (PartA, C, and D)
Hemocyte test
Measured: Up to 84 days
Pharmacodynamics (Part B and C)
Anti-KLH antibody
Measured: Up to 84 days
Immunogenicity (PartA, C, and D)
Anti-ONO-4685 antibody
Measured: Up to 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start12 Sep 2019
- Primary completion25 May 2021
- Study completion25 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Junichiro Manako, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079062
- Sponsor's protocol ID
- ONO-4685-01
- Status last verified
- May 2024
- First submitted
- 25 Aug 2019
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Ascending Dose Study to Assess the Safety, Tolerability, PK and PD of ONO-4685 in Japanese and Caucasian Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT04079062
- Acronym / sponsor ID
- ONO-4685-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2019 (actual)
- Primary completion
- 25 May 2021 (actual)
- Study completion
- 25 May 2021 (actual)
- First posted
- 6 Sep 2019 (actual)
- 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.
To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity in Japanese and Caucasian healthy adult male subjects when ONO-4685 is administered as a single-dose by intravenous infusion.
Detailed description
To investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity when ONO-4685 is administered by single-dose intravenous continuous infusion in Japanese and Caucasian healthy adult male subjects. In addition, in Japanese healthy adult male subjects, to investigate dosing condition of Keyhole limpet hemocyanin (KLH) and to investigate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity when ONO-4685 is administered by single-dose intravenous continuous infusion after treating with KLH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ONO-4685 (PartA, D) | Experimental | Biological: ONO-4685 |
| Placebo (PartA, D) | Placebo comparator | Biological: Placebo |
| KLH+placebo (Part B) | Experimental | Biological: KLH |
| KLH+ONO-4685 (PartC) | Experimental | Biological: KLH, ONO-4685 |
| KLH+placebo (PartC) | Experimental | Biological: KLH, placebo |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Japanese healthy adult male subjects (PartA, B, and C)
- Caucasian healthy adult male subjects (Part D)
- Age (at the time of informed consent): ≥20 yeas, ≤ 45 yeas
- Body weight (at the time of screening test): ≥50 kg
Key exclusion criteria (3 listed)
- Subjects who are on a treatment for or with a history of respiratory, cardiovascular, psychiatric, neurologic, gastrointestinal, immunologic, hepatic, renal, hematopoietic or endocrine and/or other disease.
- Subjects with current or with a history of severe allergy to drugs or foods
- Subjects with current or with a history of drug or alcohol abuse
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-4685Single ascending dose of ONO-4685 will be administered by intravenous continuous infusion at the designated speed. | Biological | ONO-4685 (PartA, D) |
| PlaceboPlacebo will be administered by intravenous continuous infusion at the designated speed. | Biological | Placebo (PartA, D) |
| KLHKLH 1 mg per dose will be subcutaneously administered. In addition, all subjects will be administered placebo after KLH administration. | Biological | KLH+placebo (Part B) |
| KLH, ONO-4685Part C will be conducted in a study design that ONO-4685 will be administered within the dose range, for which the safety has been confirmed in Part A, after administering KLH in the dose regimens selected according to the investigation result in Part B. | Biological | KLH+ONO-4685 (PartC) |
| KLH, placeboPart C will be conducted in a study design that placebo will be administered within the dose range, for which the safety has been confirmed in Part A, after administering KLH in the dose resimens selected according to the investigation result in Part B. | Biological | KLH+placebo (PartC) |
Primary outcome
Adverse events [Safety and Tolerability]
Time frame: Up to 84 days
Number of participants with adverse events as assessed by CTCAE v5.0
Vital sign [Safety and Tolerability]
Time frame: Up to 84 days
Summary statistics of blood pressure/pulse rate, respiratory rate, SpO2
Body temperature [Safety and Tolerability]
Time frame: Up to 84 days
Summary statistics of body temperature
Body weight [Safety and Tolerability]
Time frame: Up to 84 days
Summary statistics of body weight
ECG parameter test [Safety and Tolerability]
Time frame: Up to 84 days
Summary statistics of ECG parameter test (Heart Rate, RR, PR, QRS, QT, and QTcF)
Laboratory test [Safety and Tolerability]
Time frame: Up to 84 days
Summary statistics of laboratory test (hematologic test, blood biochemistry test, blood coagulation test, immunoserologic test urinalysis)
10 secondary outcomes
Cmax [Pharmacokinetic] (PartA, C, and D)
Time frame: Up to 84 days
Tmax [Pharmacokinetic] (PartA, C, and D)
Time frame: Up to 84 days
AUC [Pharmacokinetic] (PartA, C, and D)
Time frame: Up to 84 days
T1/2 [Pharmacokinetic] (PartA, C, and D)
Time frame: Up to 84 days
CL [Pharmacokinetic] (PartA, C, and D)
Time frame: Up to 84 days
Vss [Pharmacokinetic] (PartA, C, and D)
Time frame: Up to 84 days
Serum cytokine concentration [Pharmacodynamics] (PartA, C, and D)
Time frame: Up to 84 days
Hemocyte test [Pharmacodynamics] (PartA, C, and D)
Time frame: Up to 84 days
Pharmacodynamics (Part B and C)
Time frame: Up to 84 days
Immunogenicity (PartA, C, and D)
Time frame: Up to 84 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 3 May 2024.
- Individual participant dataSharing planned: No
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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.
Junichiro Manako 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-4685, KLH and KLH, ONO-4685 in people with Healthy Volunteers, run by Ono Pharmaceutical 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 4 inclusion and 3 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 3 May 2024. 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?
Adverse events [Safety and Tolerability] (time frame: Up to 84 days). The study lists 6 primary outcomes in all. 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 3 May 2024; AzTrials last refreshed its copy on 1 Nov 2026.