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

NCT05901883 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-02-09

No results posted yet for this study

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

Interventions

DRUG

CEL383

Subjects will receive CEL383

DRUG

Placebo

Subjects will receive placebo

Sponsors & Collaborators

  • Celsius Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Sarah Grant, MD · Celsius Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-20
Primary Completion
2024-01-17
Completion
2024-01-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05901883 on ClinicalTrials.gov