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FL-101-Intravenous for Healthy Subjects

Phase 1
Waitlist Available
Led By Swarna Yadlapalli, MD
Research Sponsored by Flame Biosciences
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 day 1 (predose) and days 8, 15, 22, 29, 43, 57, 71, and 85
Awards & highlights

Study Summary

This study is evaluating whether a new drug can be delivered via the subcutaneous route.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (predose) and days 8, 15, 22, 29, 43, 57, 71, and 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (predose) and days 8, 15, 22, 29, 43, 57, 71, and 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
FL-101 Absolute Bioavailability
Secondary outcome measures
Incidence of adverse events
Serum concentration of FL-101
Other outcome measures
FL-101 Antibodies

Trial Design

2Treatment groups
Experimental Treatment
Group I: FL-101-SCExperimental Treatment1 Intervention
FL-101 single SC injection
Group II: FL-101-IVExperimental Treatment1 Intervention
FL-101 single IV infusion over 60-minutes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FL-101-Intravenous
2021
Completed Phase 1
~30
FL-101-Subcutaneous
2021
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Flame BiosciencesLead Sponsor
3 Previous Clinical Trials
Swarna Yadlapalli, MDPrincipal InvestigatorAxis Clinicals
1 Previous Clinical Trials
75 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Bioavailability Study of FL-101 in Healthy Male and Female Subjects
2021. "A Bioavailability Study of FL-101 in Healthy Male and Female Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04983732.
~7 spots leftby Apr 2025
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