Clinical trial NCT05508204: Open-label Safety and PK Study of BION-1301 in Japanese Healthy Subjects
Official title: BION-1301 - A Phase 1, Open-label, Single Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Japanese Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Chinook Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-19
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Open-label, single ascending dose study in Japanese healthy subjects
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Safety and tolerability of BION-1301
timeFrame: Day 85
Secondary outcomes:
measure: Pharmacokinetics-Cmax
timeFrame: Day 85
measure: Pharmacokinetics-Tmax
timeFrame: Day 85
measure: Pharmacokinetics-AUC∞
timeFrame: Day 85
measure: Pharmacokinetics-AUClast
timeFrame: Day 85
measure: Pharmacokinetics-t1/2
timeFrame: Day 85
measure: Pharmacokinetics-CL/F
timeFrame: Day 85
measure: Pharmacokinetics-Vz/F
timeFrame: Day 85
measure: The effect of BION-1301 on pharmacodynamic (PD) parameters
timeFrame: Day 85
measure: The levels of anti-drug antibodies
timeFrame: Day 85
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
Study officials:
affiliation: Chinook Therapeutics, Inc.
name: Charlotte Jones-Burton, M.D.
role: STUDY_DIRECTOR
References: