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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CEL383; Drug: Placebo

• Registration Number: NCT05901883
• Lead Sponsor: Celsius Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-05
• Study First Submitted QC: 2023-06-05
• Study First Posted: 2023-06-13
• Study Start: 2023-06-20
• Primary Completion: 2024-01-17
• Study Completion: 2024-01-17
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CEL383 Arm	CEL383	Subjects will receive a single intravenous dose of CEL383
Placebo Arm	Placebo	Subjects will receive a single intravenous dose of placebo

Primary Outcome Measures

Name	Time	Method
Treatment-emergent adverse events (TEAEs)	Through the Day 85 study visit	Incidence of TEAEs by type, severity, seriousness, and relationship

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Celerion; 🇺🇸 Lincoln, Nebraska, United States