Clincosm LogoSign in Get a demo

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

Sponsor
Celsius Therapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05901883
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
7
Anticipated Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: CEL383 Arm

Subjects will receive a single intravenous dose of CEL383

Drug: CEL383
Subjects will receive CEL383
Placebo Comparator: Placebo Arm

Subjects will receive a single intravenous dose of placebo

Drug: Placebo
Subjects will receive placebo

Outcome Measures

Primary Outcome Measures

  1. Treatment-emergent adverse events (TEAEs) [Through the Day 85 study visit]

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

Secondary Outcome Measures

  1. Cmax [Day 1 through Day 85]

    Maximum concentration after single ascending dose

  2. Tmax [Day 1 through Day 85]

    Time to reach maximum concentration after single ascending dose

  3. t1/2 [Day 1 through Day 85]

    Half-life after single ascending dose

  4. AUC [Day 1 through Day 85]

    Area under the curve after single ascending dose

  5. ADA [Day 1 through Day 85]

    Incidence of anti-drug antibody after single ascending dose

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Celerion Lincoln Nebraska United States 68502

Sponsors and Collaborators

  • Celsius Therapeutics, Inc.

Investigators

  • Study Director: Sarah Grant, MD, Celsius Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Celsius Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT05901883
Other Study ID Numbers:
  • 383-001
First Posted:
Jun 13, 2023
Last Update Posted:
Jun 13, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 13, 2023