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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and metabolism of a new treatment called CEL383. It is a first-time study involving healthy volunteers who will receive a single dose of either CEL383 or a placebo (a substance with no active treatment). Participants should be healthy adults, non-smokers, and have a BMI between 18 and 32. This early-phase trial focuses on understanding the basic safety of CEL383 before testing it in individuals with specific conditions. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how CEL383 works in people.

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.

Is there any evidence suggesting that CEL383 is likely to be safe for humans?

Research shows that CEL383 is undergoing its first human testing to assess safety and tolerability. As this is the initial study involving people, detailed safety information is still being gathered. Preclinical lab tests indicated that CEL383 reduces inflammation, suggesting potential efficacy with minimal side effects, though this remains unconfirmed in humans. This early-phase study primarily aims to understand the body's reaction to the drug and identify possible side effects. This careful step ensures the treatment's safety for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

CEL383 is unique because it is administered as a single intravenous dose, potentially offering a quicker and more direct delivery compared to standard treatments that often require multiple doses or oral administration. Researchers are excited about CEL383 because it may offer a new mechanism of action, potentially targeting the condition more effectively or with fewer side effects than current options. This innovative approach could lead to improved outcomes for patients and represents a significant step forward in treatment possibilities.

What evidence suggests that CEL383 could be effective?

Research has shown that CEL383 is under investigation for its potential effects on the immune system. CEL383 targets TREM1, a specific part of the immune system involved in inflammation. This component is linked to many diseases, prompting researchers to explore CEL383's potential benefits. Early animal studies demonstrated that blocking TREM1 can reduce inflammation and improve health outcomes. However, CEL383 has not yet been tested in humans, so its effects in people remain unknown. This trial will compare CEL383 with a placebo to assess its effects in healthy subjects. Further research is necessary to determine if these early results will translate to human studies. ^{1 2 6 7 8}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05901883

First-in-human, Single Ascending Dose Study of CEL383 ... First-in-human, Single Ascending Dose Study of CEL383 in Healthy Adult Subjects. ClinicalTrials.gov ID NCT05901883. Sponsor Celsius ...

2. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-5-2023-58df7

CEL383 for Healthy Subjects · Info for Participants 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.

3. synapse.patsnap.com synapse.patsnap.com/drug/183128a4ef214e27bcf081e219a495e3

CEL-383 - Drug Targets, Indications, Patents A first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety, tolerability, and pharmacokinetics of CEL383.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1043661824001567

TREM1: Activation, signaling, cancer and therapy Nangibotide (1.0 mg/kg/h) improved the clinical status and reduced mortality with no significant increase in TEAEs. NCT04429334 [140]. CEL383, Healthy subjects ...

5. academic.oup.com academic.oup.com/ecco-jcc/article/17/Supplement_1/i59/7009335

DOP02 Single cell RNA sequencing of Ulcerative Colitis and ... Single cell RNA sequencing combined with computational biology provides unprecedented insights into disease biology, informing novel therapeutic targets.

6. trial.medpath.com trial.medpath.com/clinical-trial/ba1a1f3d90efa7a5/nct05901883-first-in-human-study-cel383-safety

First-in-human, Single Ascending Dose Study of CEL383 in ... This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics ...

7. news.abbvie.com news.abbvie.com/2024-06-27-AbbVie-Acquires-Celsius-Therapeutics

AbbVie Acquires Celsius Therapeutics - Jun 27, 2024 In preclinical assays, CEL383 has been shown to inhibit TREM1 signaling, reducing the levels of multiple inflammatory mediators of high clinical ...

8. clinicaltrialsarena.com clinicaltrialsarena.com/news/celsius-therapeutics-dosing-ibd/

Celsius Therapeutics initiates dosing in trial of IBD therapy Approximately 48 healthy adult male or female subjects aged 19 to 64 years were randomised to receive CEL383 or a placebo. The study's primary ...