HealthyPhase 1NCT05901883
First-in-human, Single Ascending Dose Study of CEL383 in Healthy Adult Subjects
A Phase 1 study testing CEL383 in people with Healthy, run by Celsius Therapeutics, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CEL383
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2023to 17 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- CEL383, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEL383Drug
Subjects will receive CEL383
PlaceboDrug
Subjects will receive placebo
| Study group | Role | What they receive |
|---|---|---|
| CEL383 Arm | Experimental | Subjects will receive a single intravenous dose of CEL383 Receives: Drug: CEL383 |
| Placebo Arm | Placebo comparator | Subjects will receive a single intravenous dose of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-emergent adverse events (TEAEs)
Incidence of TEAEs by type, severity, seriousness, and relationship
Measured: Through the Day 85 study visit
Secondary outcomes (5)
Cmax
Maximum concentration after single ascending dose
Measured: Day 1 through Day 85
Tmax
Time to reach maximum concentration after single ascending dose
Measured: Day 1 through Day 85
t1/2
Half-life after single ascending dose
Measured: Day 1 through Day 85
AUC
Area under the curve after single ascending dose
Measured: Day 1 through Day 85
ADA
Incidence of anti-drug antibody after single ascending dose
Measured: Day 1 through Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start20 Jun 2023
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celsius Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Grant, MD, Study director, Celsius Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901883
- Sponsor's protocol ID
- 383-001
- Status last verified
- Feb 2024
- First submitted
- 5 Jun 2023
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05901883
- Acronym / sponsor ID
- 383-001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Celsius Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEL383 Arm | Experimental | Drug: CEL383Subjects will receive a single intravenous dose of CEL383 |
| Placebo Arm | Placebo comparator | Drug: PlaceboSubjects will receive a single intravenous dose of placebo |
Who may qualify
- Ages
- 19 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CEL383Subjects will receive CEL383 | Drug | CEL383 Arm |
| PlaceboSubjects will receive placebo | Drug | Placebo Arm |
Primary outcome
Treatment-emergent adverse events (TEAEs)
Time frame: Through the Day 85 study visit
Incidence of TEAEs by type, severity, seriousness, and relationship
5 secondary outcomes
Cmax
Time frame: Day 1 through Day 85
Tmax
Time frame: Day 1 through Day 85
t1/2
Time frame: Day 1 through Day 85
AUC
Time frame: Day 1 through Day 85
ADA
Time frame: Day 1 through Day 85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Grant, MD study director
Celsius Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CEL383 in people with Healthy, run by Celsius Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-emergent adverse events (TEAEs) (time frame: Through the Day 85 study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.