Healthy
Conditions
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.
Interventions
DRUGCEL383
Subjects will receive CEL383
DRUGPlacebo
Subjects will receive placebo
Sponsors
Celsius Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent adverse events (TEAEs) | Through the Day 85 study visit | Incidence of TEAEs by type, severity, seriousness, and relationship |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| t1/2 | Day 1 through Day 85 | Half-life 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 |
Countries
United States
Outcome results
None listed