Healthy VolunteerPhase 1NCT05508204
Open-label Safety and PK Study of BION-1301 in Japanese Healthy Subjects
A Phase 1 study testing BION-1301 in people with Healthy Volunteer, run by Chinook Therapeutics, Inc. at 1 site in United States.
Trial summary
Phase 1, open-label study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic of multiple doses of BION-1301 in Japanese healthy subjects. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- BION-1301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jul 2022to 16 Dec 2022
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- First generation Japanese (confirmed at screening). The definition of first generation is the subject, the subject's biological parents, and the subject's biological grandparents are of exclusively Japanese origin and were born in Japan.
- Body mass index (BMI) between 18 and 30 kg/m^2, inclusive, at screening with a weight of at least 47 kg.
- In good health, as determined by medical history, physical examination, vital signs assessment, 12-lead ECG, and clinical laboratory evaluations within normal reference ranges or outside of normal reference ranges considered not clinically relevant by the investigator
- Female subjects of childbearing potential must have a negative urine or serum pregnancy test, must agree to try to not become pregnant, must agree to consistently use highly effective contraceptive methods, and must agree not to breastfeed or donate ova for a period as defined in the study protocol.
- Male subjects must agree to use highly effective contraceptive methods and must not donate sperm for a period as defined in the study protocol.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- History of malignancy during the last 3 years; exceptions include adequately treated basal cell carcinoma and squamous cell carcinoma of the skin
- Confirmed systolic blood pressure >140 or <90 mmHg, diastolic blood pressure >90 or <50 mmHg, and pulse rate >100 or <40 beats per minute at either screening or predose on Day 1.
- Received a live (attenuated) vaccine(s) within 3 months prior to check-in and/or a vaccine(s) that do not contain live microorganism(s) within 14 days prior to check-in.
- Have previously completed or withdrawn from this study or any other study investigating BION-1301, and have previously received BION-1301.
- Positive urine drug screen, alcohol test, or cotinine test at screening or check-in.
Trial locations and contacts
1 site in 1 country.
United States1 site
Collaborative Neuroscience Research, LLC
Long Beach, California, 90806
About this study
Official title: BION-1301 - A Phase 1, Open-label, Single Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Japanese Healthy Subjects
Phase 1, open-label study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic of multiple doses of BION-1301 in Japanese healthy subjects.
Read the detailed description
This is a Phase 1 study of BION-1301, a first-in-class humanized IgG4 anti-a proliferation-inducing ligand (APRIL) monoclonal antibody. This is a single-center, open-label study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic of a single subcutaneous dose of BION-1301 in Japanese healthy subjects in 3 dose level cohorts. The study will enroll up to 36 Japanese subjects across 3 dose level cohorts.
- Conditions
- Healthy Volunteer
- Being tested
- BION-1301
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BION-1301Drug
A solution for SC injection administered as a single dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level A Receives: Drug: BION-1301 |
| Cohort B | Experimental | A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level B Receives: Drug: BION-1301 |
| Cohort C | Experimental | A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level C Receives: Drug: BION-1301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of BION-1301
Number of subjects with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs); changes from baseline in safety parameters; and number of subjects with injection site reactions
Measured: Day 85
Secondary outcomes (9)
Pharmacokinetics-Cmax
Maximum plasma concentration
Measured: Day 85
Pharmacokinetics-Tmax
Time at which the maximum plasma concentration (Cmax) occurs
Measured: Day 85
Pharmacokinetics-AUC∞
Area under the plasma concentration-time curve from dosing (time zero) extrapolated to infinity
Measured: Day 85
Pharmacokinetics-AUClast
Area under the plasma concentration-time curve from dosing (time zero) to the time of the last measured concentration
Measured: Day 85
Pharmacokinetics-t1/2
Time required for the drug concentration to decrease by a factor of one-half in the terminal phase
Measured: Day 85
Pharmacokinetics-CL/F
Serum concentration after single dose will be measured and the apparent oral clearance will be calculated
Measured: Day 85
Pharmacokinetics-Vz/F
Serum concentration after single dose will be measured and the apparent volume of distribution will be calculated
Measured: Day 85
The effect of BION-1301 on pharmacodynamic (PD) parameters
Changes in immunoglobulin levels (IgA, IgG, and IgM)
Measured: Day 85
The levels of anti-drug antibodies
Blood anti-drug antibodies (ADA) and neutralizing antibody (NAb) levels
Measured: Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start19 Jul 2022
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Open-label, single ascending dose study in Japanese healthy subjects
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinook Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charlotte Jones-Burton, M.D., Study director, Chinook Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508204
- Sponsor's protocol ID
- CHK02-01
- Status last verified
- Jan 2023
- First submitted
- 17 Aug 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BION-1301 - A Phase 1, Open-label, Single Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Japanese Healthy Subjects
- ClinicalTrials.gov ID
- NCT05508204
- Acronym / sponsor ID
- CHK02-01
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Chinook Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 19 Aug 2022 (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.
Phase 1, open-label study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic of multiple doses of BION-1301 in Japanese healthy subjects.
Detailed description
This is a Phase 1 study of BION-1301, a first-in-class humanized IgG4 anti-a proliferation-inducing ligand (APRIL) monoclonal antibody. This is a single-center, open-label study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic of a single subcutaneous dose of BION-1301 in Japanese healthy subjects in 3 dose level cohorts. The study will enroll up to 36 Japanese subjects across 3 dose level cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Open-label, single ascending dose study in Japanese healthy subjects
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: BION-1301A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level A |
| Cohort B | Experimental | Drug: BION-1301A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level B |
| Cohort C | Experimental | Drug: BION-1301A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level C |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- First generation Japanese (confirmed at screening). The definition of first generation is the subject, the subject's biological parents, and the subject's biological grandparents are of exclusively Japanese origin and were born in Japan.
- Body mass index (BMI) between 18 and 30 kg/m^2, inclusive, at screening with a weight of at least 47 kg.
- In good health, as determined by medical history, physical examination, vital signs assessment, 12-lead ECG, and clinical laboratory evaluations within normal reference ranges or outside of normal reference ranges considered not clinically relevant by the investigator
- Female subjects of childbearing potential must have a negative urine or serum pregnancy test, must agree to try to not become pregnant, must agree to consistently use highly effective contraceptive methods, and must agree not to breastfeed or donate ova for a period as defined in the study protocol.
- Male subjects must agree to use highly effective contraceptive methods and must not donate sperm for a period as defined in the study protocol.
Key exclusion criteria (6 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- History of malignancy during the last 3 years; exceptions include adequately treated basal cell carcinoma and squamous cell carcinoma of the skin
- Confirmed systolic blood pressure >140 or <90 mmHg, diastolic blood pressure >90 or <50 mmHg, and pulse rate >100 or <40 beats per minute at either screening or predose on Day 1.
- Received a live (attenuated) vaccine(s) within 3 months prior to check-in and/or a vaccine(s) that do not contain live microorganism(s) within 14 days prior to check-in.
- Have previously completed or withdrawn from this study or any other study investigating BION-1301, and have previously received BION-1301.
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 |
|---|---|---|
| BION-1301A solution for SC injection administered as a single dose | Drug | Cohort A, Cohort B, Cohort C |
Primary outcome
Safety and tolerability of BION-1301
Time frame: Day 85
Number of subjects with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs); changes from baseline in safety parameters; and number of subjects with injection site reactions
9 secondary outcomes
Pharmacokinetics-Cmax
Time frame: Day 85
Pharmacokinetics-Tmax
Time frame: Day 85
Pharmacokinetics-AUC∞
Time frame: Day 85
Pharmacokinetics-AUClast
Time frame: Day 85
Pharmacokinetics-t1/2
Time frame: Day 85
Pharmacokinetics-CL/F
Time frame: Day 85
Pharmacokinetics-Vz/F
Time frame: Day 85
The effect of BION-1301 on pharmacodynamic (PD) parameters
Time frame: Day 85
The levels of anti-drug antibodies
Time frame: Day 85
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 11 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteer
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.
Charlotte Jones-Burton, M.D. study director
Chinook Therapeutics, Inc.
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 BION-1301 in people with Healthy Volunteer, run by Chinook Therapeutics, 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 5 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 11 Jan 2023. 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 BION-1301 (time frame: Day 85). 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 11 Jan 2023.