Open-label Safety and PK Study of BION-1301 in Japanese Healthy Subjects

• ClinicalTrials.gov Identifier: NCT05508204
• Recruitment Status: Completed
• First Posted: August 19, 2022
• Last Update Posted: January 11, 2023
• Sponsor: Chinook Therapeutics, Inc.
• Information provided by (Responsible Party): Chinook Therapeutics, Inc.

Tracking Information

• First Submitted Date: August 17, 2022
• First Posted Date: August 19, 2022
• Last Update Posted Date: January 11, 2023
• Actual Study Start Date: July 19, 2022
• Actual Primary Completion Date: December 16, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 17, 2022)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 17, 2022)

• Pharmacokinetics-Cmax [ Time Frame: Day 85 ]
  Maximum plasma concentration
• Pharmacokinetics-Tmax [ Time Frame: Day 85 ]
  Time at which the maximum plasma concentration (Cmax) occurs
• Pharmacokinetics-AUC∞ [ Time Frame: Day 85 ]
  Area under the plasma concentration-time curve from dosing (time zero) extrapolated to infinity
• Pharmacokinetics-AUClast [ Time Frame: Day 85 ]
  Area under the plasma concentration-time curve from dosing (time zero) to the time of the last measured concentration
• Pharmacokinetics-t1/2 [ Time Frame: Day 85 ]
  Time required for the drug concentration to decrease by a factor of one-half in the terminal phase
• Pharmacokinetics-CL/F [ Time Frame: Day 85 ]
  Serum concentration after single dose will be measured and the apparent oral clearance will be calculated
• Pharmacokinetics-Vz/F [ Time Frame: Day 85 ]
  Serum concentration after single dose will be measured and the apparent volume of distribution will be calculated
• The effect of BION-1301 on pharmacodynamic (PD) parameters [ Time Frame: Day 85 ]
  Changes in immunoglobulin levels (IgA, IgG, and IgM)
• The levels of anti-drug antibodies [ Time Frame: Day 85 ]
  Blood anti-drug antibodies (ADA) and neutralizing antibody (NAb) levels

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

Open-label, single ascending dose study in Japanese healthy subjects

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Healthy Volunteer

Intervention

Drug: BION-1301

A solution for SC injection administered as a single dose

Study Arms

• Experimental: Cohort A
  A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level A
  Intervention: Drug: BION-1301
• Experimental: Cohort B
  A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level B
  Intervention: Drug: BION-1301
• Experimental: Cohort C
  A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level C
  Intervention: Drug: BION-1301

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 17, 2022): 36
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 16, 2022
• Actual Primary Completion Date: December 16, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05508204
• Other Study ID Numbers: CHK02-01
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Chinook Therapeutics, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Chinook Therapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Charlotte Jones-Burton, M.D.; Chinook Therapeutics, Inc.

• PRS Account: Chinook Therapeutics, Inc.
• Verification Date: January 2023