BION-1301 for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Collaborative Neuroscience Research, LLC, Long Beach, CA
Healthy Subjects (HS)
BION-1301 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
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Study Summary

Phase 1, open-label study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic of multiple doses of BION-1301 in Japanese healthy subjects.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Day 85

Day 85
Pharmacokinetics-AUClast
Pharmacokinetics-AUC∞
Pharmacokinetics-CL/F
Pharmacokinetics-Cmax
Pharmacokinetics-Tmax
Pharmacokinetics-Vz/F
Pharmacokinetics-t1/2
Safety and tolerability of BION-1301
The effect of BION-1301 on pharmacodynamic (PD) parameters
The levels of anti-drug antibodies

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Trial Design

3 Treatment Groups

Cohort C
1 of 3
Cohort B
1 of 3
Cohort A
1 of 3
Experimental Treatment

36 Total Participants · 3 Treatment Groups

Primary Treatment: BION-1301 · No Placebo Group · Phase 1

Cohort C
Drug
Experimental Group · 1 Intervention: BION-1301 · Intervention Types: Drug
Cohort B
Drug
Experimental Group · 1 Intervention: BION-1301 · Intervention Types: Drug
Cohort A
Drug
Experimental Group · 1 Intervention: BION-1301 · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 85
Closest Location: Collaborative Neuroscience Research, LLC · Long Beach, CA
2021First Recorded Clinical Trial
4 TrialsResearching Healthy Subjects (HS)
9 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a Japanese citizen, or have Japanese citizenship, and your biological parents are of exclusively Japanese origin and were born in Japan.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.