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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: BION-1301

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
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chinook Therapeutics, Inc.; Phone Number: (206) 485-7051; Email: clinicaltrials@chinooktx.com

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A; A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level A	Drug: BION-1301; A solution for SC injection administered as a single dose
Experimental: Cohort B; A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level B	Drug: BION-1301; A solution for SC injection administered as a single dose
Experimental: Cohort C; A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level C	Drug: BION-1301; A solution for SC injection administered as a single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 85

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinook Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2022
• Primary Completion (Actual): December 16, 2022
• Study Completion (Actual): December 16, 2022

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CHK02-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No