CEL383 for Healthy Subjects

Overseen By Sarah Grant, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Celsius Therapeutics, Inc.

Disqualifiers: Immunodeficiency, Infection, Clotting disorder, others

Compensation: Varies

Number of Visits: 86

Duration: 1 day

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy volunteers with no significant medical history, it's likely that participants should not be on any regular medications.

Who Is on the Research Team?

Sarah Grant, MD

Principal Investigator

Celsius Therapeutics, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Healthy, adult, male or female (of nonchildbearing potential only), 19-64 years of age, inclusive, at screening visit

Willingness of men of reproductive potential to agree to use a condom with spermicide or abstain from heterosexual intercourse from dosing until at least 90 days after dosing

Continuous nonsmoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to dosing

Exclusion Criteria

History or presence of any known primary or secondary immunodeficiency disorder

History or presence of any signs, symptoms, or diagnosis of infection, including nausea, vomiting, fever, rash, confusion, muscle aches, cough, nasal congestion, or shortness of breath, in the 4 weeks prior to screening or during the screening period

History or presence of any known clotting or hemostasis disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravenous dose of CEL383 or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Multiple visits (in-person) through Day 85

What Are the Treatments Tested in This Trial?

Interventions

• CEL383
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: CEL383 Arm Experimental Treatment 1 Intervention

Subjects will receive a single intravenous dose of CEL383

Group II: Placebo Arm Placebo Group 1 Intervention

Subjects will receive a single intravenous dose of placebo

Who Is Running the Clinical Trial?

Celsius Therapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

190+