BurnsPhase 1NCT06223009
Phase 1 Healthy Volunteer Burn Therapy Study
A Phase 1 study testing cNP8 in people with Burns, run by Neomatrix Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, first-in-human study to evaluate the safety of an investigational drug to treat burns. Participants will be healthy male and female adults. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Burns
- What is being tested?
- cNP8
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2024to 23 Jul 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI between 18 kg/m2 to 32 kg/m2 and body weight of greater than or equal to 50 kg.
- Use of highly-effective methods of birth control
- Willing and able to remain in a clinical research unit for the required study duration and return for the outpatient visit
Who cannot join
- A clinically significant laboratory abnormality or other finding indicative of a clinically-significant exclusionary disease
- A history of asymptomatic or mild COVID within 30 days of study drug administration
- A history of hospitalization with COVID within 6 months prior to study drug administration
- A history of COVID vaccination within 1 month prior to study drug administration
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 Examine the Safety, Tolerability, and Pharmacokinetics of cNP8 in Healthy Adults
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, first-in-human study to evaluate the safety of an investigational drug to treat burns. Participants will be healthy male and female adults. The study will consist of a screening period, inpatient dosing and observation period and safety follow-up. Participants will receive 1 intravenous dose of the investigational drug or placebo. Duration of participation will be approximately 38 days, which includes a maximum of a 30 day screening period and a study period of approximately 8 days.
Read the detailed description
Up to 32 healthy, male and female subjects will be enrolled in this Phase 1, single-center, randomized, double-blind, placebo-controlled, first-in-human study. Eligible subjects will be confined to a Phase 1 unit for approximately 48 hours and receive a one time IV dose of study medication. They will be required to return for a safety follow-up visit one week later.
Doses will be studied sequentially starting with the lowest dose of the investigational drug, cNP8. Each dose cohort will include a total of 6 subjects dosed with cNP8 and 2 subjects dosed with placebo.
A sentinel dosing plan with staggered enrollment will be employed. For each dosing cohort, 2 subjects will be dosed (1 with cNP8 and 1 with placebo) and monitored for serious and/or severe adverse events (AEs). If no serious or severe AEs occur in 24 hours postdose, the remaining 6 subjects in the cohort will be dosed.
Safety evaluations, including laboratory tests, vital sign measurements and electrocardiograms, will be performed at several timepoints throughout the study.
- Conditions
- Burns
- Being tested
- cNP8, Placebo
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cNP8Drug
cNP8 for injection is provided as a sterile lyophilizate for solution for infusion. Subjects will receive a single 30 minute IV infusion of cNP8 at their assigned dose.
PlaceboOther
Subjects not randomized to cNP8 will receive a single 30 minute IV infusion of placebo.
| Study group | Role | What they receive |
|---|---|---|
| Single ascending doses of cNP8 | Experimental | Subjects will be randomized to receive either a single dose of cNP8 or placebo (6:2). The doses will be studied sequentially starting with the lowest cNP8 dose. Receives: Drug: cNP8 |
| Single doses of placebo administered | Placebo comparator | Subjects will be randomized to receive either a single dose of cNP8 or placebo (6:2). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events from dosing through follow-up
Clinical safety laboratory data will be collected
Measured: Day -1, Day 2, Day 8 Safety Follow-up
Incidence and severity of adverse events from dosing through follow-up
Electrocardiograms will be performed
Measured: Day -1, 1 hour postdose, 6 hours postdose, Day 2 and Day 8 Safety Follow-up
Incidence and severity of adverse events from dosing through follow-up
Vital signs
Measured: Predose, 0.25,0.50, 0.75,1,1.5, 2,4,6,12 hours postdose, Day 2 and Day 8 Safety Follow-up
Secondary outcomes (1)
Pharmacokinetic profile
Cmax
Measured: Predose, 0.25,0.50,0.75,1,1.5, 2,4,6,12 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start30 Jan 2024
- Primary completion6 May 2024
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neomatrix Therapeutics, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223009
- Sponsor's protocol ID
- NMT-cNP8-101
- Other IDs
- HT9425-23-1-1064
- Status last verified
- Nov 2024
- First submitted
- 4 Jan 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 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 Examine the Safety, Tolerability, and Pharmacokinetics of cNP8 in Healthy Adults
- ClinicalTrials.gov ID
- NCT06223009
- Acronym / sponsor ID
- NMT-cNP8-101
- Conditions
- Burns
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Neomatrix Therapeutics, Inc.University, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 25 Jan 2024 (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 Phase 1, single-center, randomized, double-blind, placebo-controlled, first-in-human study to evaluate the safety of an investigational drug to treat burns. Participants will be healthy male and female adults. The study will consist of a screening period, inpatient dosing and observation period and safety follow-up. Participants will receive 1 intravenous dose of the investigational drug or placebo. Duration of participation will be approximately 38 days, which includes a maximum of a 30 day screening period and a study period of approximately 8 days.
Detailed description
Up to 32 healthy, male and female subjects will be enrolled in this Phase 1, single-center, randomized, double-blind, placebo-controlled, first-in-human study. Eligible subjects will be confined to a Phase 1 unit for approximately 48 hours and receive a one time IV dose of study medication. They will be required to return for a safety follow-up visit one week later.
Doses will be studied sequentially starting with the lowest dose of the investigational drug, cNP8. Each dose cohort will include a total of 6 subjects dosed with cNP8 and 2 subjects dosed with placebo.
A sentinel dosing plan with staggered enrollment will be employed. For each dosing cohort, 2 subjects will be dosed (1 with cNP8 and 1 with placebo) and monitored for serious and/or severe adverse events (AEs). If no serious or severe AEs occur in 24 hours postdose, the remaining 6 subjects in the cohort will be dosed.
Safety evaluations, including laboratory tests, vital sign measurements and electrocardiograms, will be performed at several timepoints throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single ascending doses of cNP8 | Experimental | Drug: cNP8Subjects will be randomized to receive either a single dose of cNP8 or placebo (6:2). The doses will be studied sequentially starting with the lowest cNP8 dose. |
| Single doses of placebo administered | Placebo comparator | Other: PlaceboSubjects will be randomized to receive either a single dose of cNP8 or placebo (6:2). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI between 18 kg/m2 to 32 kg/m2 and body weight of greater than or equal to 50 kg.
- Use of highly-effective methods of birth control
- Willing and able to remain in a clinical research unit for the required study duration and return for the outpatient visit
Key exclusion criteria (4 listed)
- A clinically significant laboratory abnormality or other finding indicative of a clinically-significant exclusionary disease
- A history of asymptomatic or mild COVID within 30 days of study drug administration
- A history of hospitalization with COVID within 6 months prior to study drug administration
- A history of COVID vaccination within 1 month prior to study drug administration
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 |
|---|---|---|
| cNP8cNP8 for injection is provided as a sterile lyophilizate for solution for infusion. Subjects will receive a single 30 minute IV infusion of cNP8 at their assigned dose. | Drug | Single ascending doses of cNP8 |
| PlaceboSubjects not randomized to cNP8 will receive a single 30 minute IV infusion of placebo. | Other | Single doses of placebo administered |
Primary outcome
Incidence and severity of adverse events from dosing through follow-up
Time frame: Day -1, Day 2, Day 8 Safety Follow-up
Clinical safety laboratory data will be collected
Incidence and severity of adverse events from dosing through follow-up
Time frame: Day -1, 1 hour postdose, 6 hours postdose, Day 2 and Day 8 Safety Follow-up
Electrocardiograms will be performed
Incidence and severity of adverse events from dosing through follow-up
Time frame: Predose, 0.25,0.50, 0.75,1,1.5, 2,4,6,12 hours postdose, Day 2 and Day 8 Safety Follow-up
Vital signs
1 secondary outcome
Pharmacokinetic profile
Time frame: Predose, 0.25,0.50,0.75,1,1.5, 2,4,6,12 hours postdose
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 14 Nov 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 cNP8 in people with Burns, run by Neomatrix 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 3 inclusion and 4 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 14 Nov 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?
Incidence and severity of adverse events from dosing through follow-up (time frame: Day -1, Day 2, Day 8 Safety Follow-up). The study lists 3 primary outcomes in all. 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 14 Nov 2024.