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

383-001

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.

2023-06-20

2024-01-17

2024-01-17

Completed

Early phase I

48

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}

2024-02-09