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Unknown

CEL383 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Celsius Therapeutics, Inc.
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 through day 85
Awards & highlights

Study Summary

This trial tests a new drug to check its safety, how well it's tolerated and how it's absorbed by the body in healthy people.

Who is the study for?
This trial is for healthy adults aged 19-64 who don't smoke and haven't used nicotine products in the last 3 months. Participants must have a BMI between 18.0 and 32.0 kg/m2, be medically stable with no significant health issues, and not have a history of drug or alcohol abuse within the past two years.Check my eligibility
What is being tested?
The study tests CEL383, a new medication given as a single dose to see how safe it is and how the body processes it compared to a placebo (a substance with no active drug). This process involves randomly assigning participants to receive either CEL383 or placebo without knowing which one they get.See study design
What are the potential side effects?
Since this is the first time CEL383 will be tested in humans, potential side effects are unknown but may include reactions at the injection site, headaches, nausea, fatigue or other unexpected symptoms related to safety and tolerability.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 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
Treatment-emergent adverse events (TEAEs)
Secondary outcome measures
ADA
AUC
Cmax
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CEL383 ArmExperimental Treatment1 Intervention
Subjects will receive a single intravenous dose of CEL383
Group II: Placebo ArmPlacebo Group1 Intervention
Subjects will receive a single intravenous dose of placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CEL383
2023
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Celsius Therapeutics, Inc.Lead Sponsor
Sarah Grant, MDStudy DirectorCelsius Therapeutics, Inc.

Media Library

CEL383 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05901883 — Phase 1
Healthy Subjects Research Study Groups: CEL383 Arm, Placebo Arm
Healthy Subjects Clinical Trial 2023: CEL383 Highlights & Side Effects. Trial Name: NCT05901883 — Phase 1
CEL383 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05901883 — Phase 1

Frequently Asked Questions

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

Is it a requirement for participants of this trial to be under fifty years old?

"All applicants must possess an age between 19 and 64 years to be eligible for inclusion in this trial."

Answered by AI

How reliably benign is CEL383 Arm for those receiving treatment?

"As CEL383 Arm is in the early stages of clinical trials, there are limited data points confirming its safety and efficacy; as such, it has been assigned a score of 1."

Answered by AI

Are there any open enrollment opportunities for this experiment?

"According to records on clinicaltrials.gov, this trial is actively searching for participants. Initially posted in June 1st 2023 and updated recently on the 5th of that month, it seeks to recruit subjects."

Answered by AI

Who would be a viable participant for this medical experiment?

"This study is admitting 48 individuals within the bracket of 19 and 64 years old who display no health conditions."

Answered by AI

What is the aggregate figure of individuals participating in this medical trial?

"Affirmative. According to clinicaltrials.gov, this study is actively enrolling participants after first being posted on June 1st 2023 and recently edited on June 5th 2023. The trial requires 48 patients from a single location for full participation."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
First-in-human, Single Ascending Dose Study of CEL383 in Healthy Adult Subjects
2023. "First-in-human, Single Ascending Dose Study of CEL383 in Healthy Adult Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05901883.
~26 spots leftby Apr 2025
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