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G03-52-01 for Healthy Subjects

Phase 1
Waitlist Available
Led By Cassandra Key, MD
Research Sponsored by Ology Bioservices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180
Awards & highlights

Study Summary

This trial is testing four different doses of a new medication to see how well it works and if there are any side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-injection, 6 hours post injection, and on days 1, 2, 4, 8, 15, 30, 45, 60, 90, 120, and 180 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The occurrence of Adverse Events (AE) following administration of G03-52-01 to the final follow-up visit
The occurrence of Serious Adverse Events (SAE) following administration of G03-52-01 to the final follow-up visit.
The occurrence of changes from baseline in physical examination, vital signs and clinical safety laboratory values following administration of G03-52-01 to the final follow-up visit.
Secondary outcome measures
Anti-drug antibodies (ADA)
Area under the plasma concentration versus time curve (AUC)
Peak plasma concentration (Cmax)
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: 50 mg of G03-52-01Experimental Treatment2 Interventions
8 subjects randomized to 50 mg of G03-52-01 and 2 subjects randomized to placebo
Group II: 25mg of G03-52-01Experimental Treatment2 Interventions
8 subjects randomized to 25 mg of G03-52-01 and 2 subjects randomized to placebo
Group III: 10mg of G03-52-01Experimental Treatment2 Interventions
8 subjects randomized to 10 mg of G03-52-01 and 2 subjects randomized to placebo
Group IV: 100 mg of G03-52-01Experimental Treatment2 Interventions
8 subjects randomized to 100 mg of G03-52-01 and 2 subjects randomized to placebo
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?

United States Department of DefenseFED
863 Previous Clinical Trials
227,559 Total Patients Enrolled
Ology BioservicesLead Sponsor
36 Previous Clinical Trials
32,246 Total Patients Enrolled
Cassandra Key, MDPrincipal InvestigatorICON Early Phase Services, LLC
2 Previous Clinical Trials
217 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 registration open for this research initiative?

"To participate, prospects need to be within the age bracket of 18 and 45 years old with no underlying health conditions. A total of 40 individuals can join this trial."

Answered by AI

What results is this experiment attempting to produce?

"This trial's primary objective, which will be monitored over the 180 day period, is to gauge any adverse events caused by G03-52-01. Furthermore, secondary objectives include assessing peak plasma concentration (Cmax), drug concentration versus time curve (AUC) and the duration of peak drug concentrations in participants' systems following administration (Tmax)."

Answered by AI

Are any individuals younger than forty able to partake in this experiment?

"This medical trial has specified that eligible individuals must be between the ages 18 and 45. There are 50 studies covering minors, while those of a senior age have 373 trials available to them."

Answered by AI

Is enrollment presently available for this clinical experiment?

"The details on clinicaltrials.gov inform us that this particular trial, which was initially published in June 2020 and last modified in September 2022, is not searching for participants presently; however 841 other trials are actively recruiting right now."

Answered by AI

To what extent can G03-52-01 jeopardize human health?

"G03-52-01 has limited safety and efficacy data available, so our group at Power assigned it a score of 1."

Answered by AI

Who else is applying?

What state do they live in?
California
New Mexico
Texas
How old are they?
18 - 65
What site did they apply to?
ICON Early Phase Services
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate Safety and PK of a Single IM Dose of G03-52-01 vs Placebo in Adult Subjects
2020. "Study to Evaluate Safety and PK of a Single IM Dose of G03-52-01 vs Placebo in Adult Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04171115.
~8 spots leftby Apr 2025
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