SBT115301 for Safety

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Celerion, Tempe, AZ
Safety
SBT115301 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study will test the safety and effects of SBT115301 when given as a single dose to healthy adult volunteers. It is the first study being done in humans. Increasing dose levels will be given after the safety at lower dose levels is shown. Some participants will receive placebo, and neither the participants or the study staff will know what drug (SBT115301 or placebo) is being given.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: Day 1 to Day 72

Day 71
Serious adverse events
Day 72
Anti-Drug Antibodies
Pharmacokinetic Parameters: AUC(0-inf)
Pharmacokinetic Parameters: AUC(0-last)
Pharmacokinetic Parameters: Cmax
Pharmacokinetic Parameters: Tmax
Pharmacokinetic Parameters: t1/2
SBT115301 Serum Concentration
Day 71
Adverse events

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

SBT115301
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: SBT115301 · Has Placebo Group · Phase 1

SBT115301
Biological
Experimental Group · 1 Intervention: SBT115301 · Intervention Types: Biological
Placebo
Biological
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Biological

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 1 to day 72
Closest Location: Celerion · Tempe, AZ
2011First Recorded Clinical Trial
3 TrialsResearching Safety
198 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are not a participant with a history of cardiovascular disease, heart failure, or diabetes
You are sexually active and have a partner of childbearing potential.
You have received the recommended vaccinations for coronavirus disease (COVID-19) and influenza.

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.