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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
Summary
This trial is testing a new drug called CEL383 in healthy volunteers to see if it is safe and how the body handles it. Researchers are looking at how the drug is absorbed, processed, and eliminated to ensure it can be safely used in future studies.
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 through day 85
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 85
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Treatment-emergent adverse events (TEAEs)
Secondary study objectives
ADA
AUC
Cmax
+2 moreTrial 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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
In clinical trials like CEL383, the mechanisms of action for treatments in healthy subjects often focus on the drug's pharmacokinetics and pharmacodynamics. This includes how the drug is absorbed, distributed, metabolized, and excreted (ADME) in the body.
These studies are essential for determining the safety, tolerability, and appropriate dosing of new treatments. By understanding these mechanisms, researchers can ensure that the drug can be safely administered to patients, paving the way for further clinical development and eventual therapeutic use.
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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.
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Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: CEL383 Arm
- Group 2: Placebo Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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