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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05901883
• Other study ID #: 383-001
• Status: Completed
• Phase: Phase 1
• Start date: June 20, 2023
• Est. completion date: January 17, 2024

Study information

• Verified date: February 2024
• Source: Celsius Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 17, 2024
• Est. primary completion date: January 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• CEL383
Subjects will receive CEL383
• Placebo
Subjects will receive placebo

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Celsius Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-emergent adverse events (TEAEs)	Incidence of TEAEs by type, severity, seriousness, and relationship	Through the Day 85 study visit
Secondary	Cmax	Maximum concentration after single ascending dose	Day 1 through Day 85
Secondary	Tmax	Time to reach maximum concentration after single ascending dose	Day 1 through Day 85
Secondary	t1/2	Half-life after single ascending dose	Day 1 through Day 85
Secondary	AUC	Area under the curve after single ascending dose	Day 1 through Day 85
Secondary	ADA	Incidence of anti-drug antibody after single ascending dose	Day 1 through Day 85