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Monoclonal Antibodies

BION-1301 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Chinook Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 85
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and well tolerated in healthy Japanese subjects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are a Japanese citizen, or have Japanese citizenship, and your biological parents are of exclusively Japanese origin and were born in Japan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 85 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability of BION-1301
Secondary outcome measures
Pharmacokinetics-AUClast
Pharmacokinetics-AUC∞
Pharmacokinetics-CL/F
+6 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort CExperimental Treatment1 Intervention
A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level C
Group II: Cohort BExperimental Treatment1 Intervention
A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level B
Group III: Cohort AExperimental Treatment1 Intervention
A single dose of BION-1301 will be administered subcutaneously on Day 1 at dose level A
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BION-1301
2022
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Chinook Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
592 Total Patients Enrolled
Charlotte Jones-Burton, M.D.Study DirectorChinook Therapeutics, Inc.
2 Previous Clinical Trials
203 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for this research project?

"As per information hosted on clinicaltrials.gov, this medical study is still open to new participants, having been first posted on July 19th 2022 and most recently updated August 17th 2022."

Answered by AI

How many participants are participating in this trial at its maximum capacity?

"Affirmative. Sources on clinicaltrials.gov demonstrate that this experiment, which was first published on July 19th 2022, is actively enrolling patients. About 36 participants are needed from a single medical site to complete the trial."

Answered by AI

To what extent is BION-1301 hazardous to those receiving it?

"Due to the limited clinical research data available, BION-1301's safety profile has been rated a 1 on our scale of 1 to 3. This is in keeping with it being an early phase one trial."

Answered by AI

Is the age eligibility for this research limited to those over 45 years old?

"The primary eligibility criteria for this clinical trial states that the patient must be between 20 and 60 years old. For those younger than 18, there are 50 studies available while 372 exist for individuals aged 65 or older."

Answered by AI

What criteria must a potential participant meet to join this experiment?

"This clinical trial is admitting 36 individuals, aged between 20 and 60 years old with a healthy medical history. To qualify for the study, participants must also fulfill additional requirements such as having negative pregnancy or sperm donation tests (depending on gender), BMI of 18-30 kg/m^2, weight over 47kgs and first generation Japanese origin (confirmed at screening). Furthermore, to maintain eligibility female subjects of childbearing potential need to use highly effective contraceptive methods during their participation in the trial while male counterparts will have to follow the same guidelines but not donate sperm."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Collaborative Neuroscience Research, LLC
What portion of applicants met pre-screening criteria?
Met criteria
~13 spots leftby Mar 2025