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

Healthy Volunteer Clinical Trial

Official title:

BION-1301 - A Phase 1, Open-label, Single Subcutaneous Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Japanese Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05508204
• Other study ID #: CHK02-01
• Status: Completed
• Phase: Phase 1
• Start date: July 19, 2022
• Est. completion date: December 16, 2022

Study information

• Verified date: January 2023
• Source: Chinook Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• BION-1301
A solution for SC injection administered as a single dose

Locations

Country	Name	City	State
United States	Collaborative Neuroscience Research, LLC	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Chinook Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics-Cmax	Maximum plasma concentration	Day 85
Secondary	Pharmacokinetics-Tmax	Time at which the maximum plasma concentration (Cmax) occurs	Day 85
Secondary	Pharmacokinetics-AUC8	Area under the plasma concentration-time curve from dosing (time zero) extrapolated to infinity	Day 85
Secondary	Pharmacokinetics-AUClast	Area under the plasma concentration-time curve from dosing (time zero) to the time of the last measured concentration	Day 85
Secondary	Pharmacokinetics-t1/2	Time required for the drug concentration to decrease by a factor of one-half in the terminal phase	Day 85
Secondary	Pharmacokinetics-CL/F	Serum concentration after single dose will be measured and the apparent oral clearance will be calculated	Day 85
Secondary	Pharmacokinetics-Vz/F	Serum concentration after single dose will be measured and the apparent volume of distribution will be calculated	Day 85
Secondary	The effect of BION-1301 on pharmacodynamic (PD) parameters	Changes in immunoglobulin levels (IgA, IgG, and IgM)	Day 85
Secondary	The levels of anti-drug antibodies	Blood anti-drug antibodies (ADA) and neutralizing antibody (NAb) levels	Day 85