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

NCT05508204 | Completed Phase 1 FDA Drug

• 1 other identifier: CHK02-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Pharmacokinetics-Cmax

  Day 85

• Pharmacokinetics-Tmax

  Day 85

• Pharmacokinetics-AUC∞

  Day 85

• Pharmacokinetics-AUClast

  Day 85

• Pharmacokinetics-t1/2

  Day 85

Study Arms (3)

Cohort A

EXPERIMENTAL

A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level A

Drug: BION-1301

Cohort B

EXPERIMENTAL

A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level B

Drug: BION-1301

Cohort C

EXPERIMENTAL

A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level C

Drug: BION-1301

Interventions

BION-1301 DRUG

A solution for SC injection administered as a single dose

Cohort A; Cohort B; Cohort C

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinook Therapeutics, Inc.: lead

Study Sites (1)

Collaborative Neuroscience Research, LLC

Long Beach, California, 90806, United States

Location

Study Officials

• Charlotte Jones-Burton, M.D.

  Chinook Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 17, 2022
• First Posted: August 19, 2022
• Study Start: July 19, 2022
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)