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

NCT ID: NCT05901883

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2024-01-17

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CEL383 Arm

Subjects will receive a single intravenous dose of CEL383

Group Type: EXPERIMENTAL

CEL383

Intervention Type: DRUG

Subjects will receive CEL383

Placebo Arm

Subjects will receive a single intravenous dose of placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subjects will receive placebo

Interventions

CEL383

Subjects will receive CEL383

Intervention Type: DRUG

Placebo

Subjects will receive placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Celsius Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Grant, MD

Role: STUDY_DIRECTOR

Celsius Therapeutics, Inc.

Locations

Celerion

Lincoln, Nebraska, United States

Countries

United States

Other Identifiers

383-001

Identifier Type: -

Identifier Source: org_study_id