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

NCT05901883 | Completed Phase 1 FDA Drug

• 1 other identifier: 383-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Treatment-emergent adverse events (TEAEs)

  Incidence of TEAEs by type, severity, seriousness, and relationship

  Through the Day 85 study visit

Secondary Outcomes (5)

• Cmax

  Day 1 through Day 85

• Tmax

  Day 1 through Day 85

• t1/2

  Day 1 through Day 85

• AUC

  Day 1 through Day 85

• ADA

  Day 1 through Day 85

Study Arms (2)

CEL383 Arm

EXPERIMENTAL

Subjects will receive a single intravenous dose of CEL383

Drug: CEL383

Placebo Arm

PLACEBO COMPARATOR

Subjects will receive a single intravenous dose of placebo

Drug: Placebo

Interventions

CEL383 DRUG

Subjects will receive CEL383

CEL383 Arm

Placebo DRUG

Subjects will receive placebo

Placebo Arm

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Celsius Therapeutics, Inc.: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Study Officials

• Sarah Grant, MD

  Celsius Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 13, 2023
• Study Start: June 20, 2023
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)