First-in-human, Single Ascending Dose Study of CEL383 in Healthy Adult Subjects

Study Overview
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Brief Summary
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This is a first-in-human, randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of CEL383 in healthy volunteers.

Official Title
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A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of CEL383 When Administered Intravenously to Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: CEL383
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at screening visit Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and ECGs Exclusion Criteria: Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study History or presence of alcohol or drug abuse within the past 2 years prior to dosing 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 Female subject of childbearing potential

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CEL383 Arm<br>Subjects will receive a single intravenous dose of CEL383 | Drug: CEL383<br>* Subjects will receive CEL383<br>|
| Placebo Comparator: Placebo Arm<br>Subjects will receive a single intravenous dose of placebo | Drug: Placebo<br>* Subjects will receive placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-emergent adverse events (TEAEs) | Incidence of TEAEs by type, severity, seriousness, and relationship | Through the Day 85 study visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum concentration after single ascending dose | Day 1 through Day 85 | 
| Tmax | Time to reach maximum concentration after single ascending dose | Day 1 through Day 85 | 
| t1/2 | Half-life after single ascending dose | Day 1 through Day 85 | 
| AUC | Area under the curve after single ascending dose | Day 1 through Day 85 | 
| ADA | Incidence of anti-drug antibody after single ascending dose | Day 1 through Day 85 |