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SBT115301 Safety Evaluation in Healthy Participants

Phase 1
Waitlist Available
Led By Michelle Valentine, DO
Research Sponsored by Sonoma Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males or females not of childbearing potential
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 72 (cohorts 1-4) or day 141 (cohort 5)
Awards & highlights

Study Summary

This trial will test a new drug, SBT115301, given as a single dose to healthy adults to see if it is safe and what effects it has.

Who is the study for?
Healthy adults who can't have children, with normal medical exams, vital signs, heart tests (ECG), and lab results. Men must use effective birth control if their partners could get pregnant. Participants need to be vaccinated for COVID-19 and flu.Check my eligibility
What is being tested?
The trial is testing SBT115301's safety by giving a single dose to healthy people. It starts at low doses which increase once proven safe. Some will get a placebo instead of the drug, and no one knows who gets what.See study design
What are the potential side effects?
Since this is the first test in humans, specific side effects are unknown but may include typical reactions seen in early-stage trials such as headaches, nausea, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am not able to have children.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 72 (cohorts 1-4) or day 141 (cohort 5)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 72 (cohorts 1-4) or day 141 (cohort 5) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse events
Serious adverse events
Secondary outcome measures
Anti-Drug Antibodies
Pharmacokinetic Parameters: AUC(0-inf)
Pharmacokinetic Parameters: AUC(0-last)
+4 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort 5Experimental Treatment2 Interventions
Intravenous (IV) dose level 1
Group II: Cohort 4Experimental Treatment2 Interventions
IM dose level 4
Group III: Cohort 3Experimental Treatment2 Interventions
IM dose level 3
Group IV: Cohort 2Experimental Treatment2 Interventions
IM dose level 2
Group V: Cohort 1Experimental Treatment2 Interventions
Intramuscular (IM) dose level 1
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sonoma Biotherapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
48 Total Patients Enrolled
Michelle Valentine, DOPrincipal InvestigatorCelerion
2 Previous Clinical Trials
50 Total Patients Enrolled
Leonard L Dragone, MD, PhDStudy DirectorSonoma Biotherapeutics, Inc.

Frequently Asked Questions

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

What are the projected benefits this clinical trial seeks to realize?

"The primary metric monitored in this trial from the day of treatment to 71 days after is serious adverse events. Secondary objectives include tracking pharmacokinetic parameters such as Cmax (maximum serum concentration), t1/2 (terminal elimination half-life) and Tmax (time of maximum SBT115301 serum concentration)."

Answered by AI

Am I eligible for enrollment in this research endeavor?

"To qualify for this clinical trial, individuals must be between 18 and 65 years of age have confirmed safety. In addition, they should not possess the capacity to bear children (for both genders) plus display general health via medical history check-ups, physical exams, vital signs recording, electrocardiograms and laboratory tests. Furthermore, participants ought to use reliable contraception methods (particularly applicable for males engaging in sexual activity with potential childbearing partners). Vaccination against COVID-19 and influenza is also essential."

Answered by AI

Are minors eligible to participate in the research trial?

"As per the requirements of this clinical trial, potential participants must be at least 18 years old and no more than 65."

Answered by AI

What is the cap on the total number of participants in this medical study?

"Affirmative. The data hosted on clinicaltrials.gov attests to the fact that this medical study, which was initially posted on July 25th 2022 is currently recruiting patients. Forty participants must be enrolled from a single medical facility."

Answered by AI

Is enrollment for this trial still open?

"Clinicaltrials.gov states that this medical experiment is currently looking for participants. It was posted on July 25th 2022 and had its most recent edit made in the beginning of August, 2022."

Answered by AI

Has SBT115301 been given the green light by the Food and Drug Administration?

"There is limited evidence to support the safety of SBT115301, so it scored a 1 on our team's scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Single Doses of SBT115301 in Healthy Participants
2022. "Study of Single Doses of SBT115301 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05388981.
~2 spots leftby Jun 2024
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