What side effects are associated with this type of intervention?

In first-in-human trials similar to the CEL383 study, common side effects typically include mild to moderate adverse events such as injection site reactions, dizziness, headache, nausea, and fatigue. Severe adverse events are rare but can include allergic reactions or other systemic effects.

What prior FDA approvals exist?

FDA approvals for treatments in healthy subjects often involve early-phase clinical trials that assess the safety, tolerability, and pharmacokinetics of new drugs. These studies are crucial for determining appropriate dosing and identifying potential side effects. Examples include various investigational drugs across therapeutic areas, such as novel small molecules, biologics, and other innovative therapies. These trials ensure that the drugs are safe for further testing in patient populations.

What other types of research exist?

Promising novel alternatives to CEL383 include T-3256336, a small-molecule antagonist of inhibitor of apoptosis proteins with anticancer potential, and UAMC-3203, a ferroptosis inhibitor with in vivo efficacy and no observed toxicity in mice. Both compounds have shown significant therapeutic potential and are worthy of further evaluation and development.

← Back to Search

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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 85 for reporting.

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 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

Do I qualify?Apply below to find out

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.

Broccoli or Sulforaphane: Is It the Source or Dose That Matters?