HealthyPhase 1NCT06640920
A Study to Investigate Efficacy and Safety of NSI-8226 in Healthy Participants
A Phase 1 study testing Cohort A, Cohort B and Cohort C in people with Healthy, run by Uniquity One (UNI) at 1 site in United States.
Trial summary
A Phase 1 Randomized, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Bioavailability of NSI-8226 in Healthy Participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cohort A, Cohort B and Cohort C
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2024to 29 Oct 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
- 1. At the time of initial screening, in general good health (age 18 to 65 years);
Who cannot join
- Pregnancy or breastfeeding during the study.
- Chronic infection - Treatment with prohibited medications.
- Treatment with prohibited medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomized, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Bioavailability of NSI-8226 in Healthy Participants
A Phase 1 Randomized, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Bioavailability of NSI-8226 in Healthy Participants.
- Conditions
- Healthy
- Being tested
- Cohort A, Cohort B, Cohort C, Cohort D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohort ABiological
Administered IV High dose
Cohort BBiological
Administered SC Low Dose
Cohort CBiological
Administered SC Mid Dose
Cohort DBiological
Administered SC High Dose
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | NSI-8226 Receives: Biological: Cohort A |
| Cohort B | Experimental | NSI-8226 Receives: Biological: Cohort B |
| Cohort C | Experimental | NSI-8226 Receives: Biological: Cohort C |
| Cohort D | Experimental | NSI-8226 Receives: Biological: Cohort D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
To evaluate the incidence of treatment emergent adverse events of NSI-8826 in healthy participants according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0
Measured: 140 days
Secondary outcomes (3)
Absolute bioavailability
Pharmacokinetics (PK) and absolute bioavailability of NSI-8226 in healthy participants.
Measured: 140 days
Concentration of immunogenicity
Immunogenicity profile of NSI-8226 in healthy participants.
Measured: 140 days
Parameters in healthy participants
Pharmacodynamic (PD) parameters of NSI-8226 in healthy participants.
Measured: 140 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start29 Apr 2024
- Primary completion29 Oct 2024
- Study completion29 Oct 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniquity One (UNI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew W Lee, MD, Study chair, Vice President, Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640920
- Sponsor's protocol ID
- NSI-8226-101
- Status last verified
- Aug 2025
- First submitted
- 13 Sep 2024
- Last updated
- 12 Aug 2025
- 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 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Bioavailability of NSI-8226 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06640920
- Acronym / sponsor ID
- NSI-8226-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Uniquity One (UNI)Industry (pharma, biotech, devices)
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 29 Oct 2024 (actual)
- Study completion
- 29 Oct 2024 (actual)
- First posted
- 15 Oct 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.
A Phase 1 Randomized, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Bioavailability of NSI-8226 in Healthy Participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Biological: Cohort ANSI-8226 |
| Cohort B | Experimental | Biological: Cohort BNSI-8226 |
| Cohort C | Experimental | Biological: Cohort CNSI-8226 |
| Cohort D | Experimental | Biological: Cohort DNSI-8226 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. At the time of initial screening, in general good health (age 18 to 65 years);
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding during the study.
- Chronic infection - Treatment with prohibited medications.
- Treatment with prohibited medications
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 |
|---|---|---|
| Cohort AAdministered IV High dose | Biological | Cohort A |
| Cohort BAdministered SC Low Dose | Biological | Cohort B |
| Cohort CAdministered SC Mid Dose | Biological | Cohort C |
| Cohort DAdministered SC High Dose | Biological | Cohort D |
Primary outcome
Safety and tolerability
Time frame: 140 days
To evaluate the incidence of treatment emergent adverse events of NSI-8826 in healthy participants according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0
3 secondary outcomes
Absolute bioavailability
Time frame: 140 days
Concentration of immunogenicity
Time frame: 140 days
Parameters in healthy participants
Time frame: 140 days
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 12 Aug 2025.
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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.
Andrew W Lee, MD study chair
Vice President, Clinical Research
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 Cohort A, Cohort B and Cohort C in people with Healthy, run by Uniquity One (UNI) 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 1 inclusion and 3 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 12 Aug 2025. 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. 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?
Safety and tolerability (time frame: 140 days). 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 12 Aug 2025.