HealthyPhase 1NCT06868082
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Solrikitug in Healthy Japanese and Non-Japanese Participants
A Phase 1 study testing Solrikitug in people with Healthy, run by Uniquity One (UNI) at 1 site in Australia.
Trial summary
A Phase 1, Open-Label Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Formulations of Subcutaneously Administered Solrikitug in Healthy Japanese and non-Japanese Participants Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Solrikitug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- 20 Jun 2025to 2 Feb 2026
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- At the time of initial screening, in general good health (age 18 to 55 years);
- Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring
- Participant must agree to use contraception during the treatment period and until follow-up
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions of the study
Who cannot join
- Pregnancy or breastfeeding during the study
- Chronic infection
- Treatment with prohibited medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Formulations of Subcutaneously Administered Solrikitug in Healthy Japanese and Non-Japanese Participants
A Phase 1, Open-Label Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Formulations of Subcutaneously Administered Solrikitug in Healthy Japanese and non-Japanese Participants
- Conditions
- Healthy
- Being tested
- Solrikitug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SolrikitugBiological
Solrikitug Formulation 1
SolrikitugBiological
Solrikitug Formulation 2
| Study group | Role | What they receive |
|---|---|---|
| Cohort A Solrikitug | Experimental | Not described Receives: Biological: Solrikitug |
| Cohort B Solrikitug | Experimental | Not described Receives: Biological: Solrikitug |
| Cohort C Solrikitug | Experimental | Not described Receives: Biological: Solrikitug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Treatment-Emergent Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0
Measured: 165 days
Secondary outcomes (2)
Serum concentration of solrikitug
Pharmacokinetics (PK) of solrikitug in healthy participants
Measured: 112 days
Concentration of Immunogenicity
Immunogenicity profile of solrikitug in healthy participants
Measured: 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start20 Jun 2025
- Primary completion2 Feb 2026
- Study completion2 Feb 2026
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniquity One (UNI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Lee, MD, Study chair, Uniquity One
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868082
- Sponsor's protocol ID
- NSI-8226-102
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Formulations of Subcutaneously Administered Solrikitug in Healthy Japanese and Non-Japanese Participants
- ClinicalTrials.gov ID
- NCT06868082
- Acronym / sponsor ID
- NSI-8226-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Uniquity One (UNI)Industry (pharma, biotech, devices)
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 10 Mar 2025 (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, Open-Label Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Two Formulations of Subcutaneously Administered Solrikitug in Healthy Japanese and non-Japanese Participants
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A Solrikitug | Experimental | Biological: Solrikitug |
| Cohort B Solrikitug | Experimental | Biological: Solrikitug |
| Cohort C Solrikitug | Experimental | Biological: Solrikitug |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- At the time of initial screening, in general good health (age 18 to 55 years);
- Participants who are healthy as determined by medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring
- Participant must agree to use contraception during the treatment period and until follow-up
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions of the study
Key exclusion criteria (3 listed)
- Pregnancy or breastfeeding during the study
- Chronic infection
- 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 |
|---|---|---|
| SolrikitugSolrikitug Formulation 1 | Biological | Cohort A Solrikitug |
| SolrikitugSolrikitug Formulation 2 | Biological | Cohort B Solrikitug, Cohort C Solrikitug |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 165 days
Treatment-Emergent Adverse Events according to Common Terminology Criteria for Adverse Events (CTCAE) V4.0
2 secondary outcomes
Serum concentration of solrikitug
Time frame: 112 days
Concentration of Immunogenicity
Time frame: 112 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 9 Feb 2026.
- Individual participant dataSharing planned: Yes
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 Lee, MD study chair
Uniquity One
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 Solrikitug in people with Healthy, run by Uniquity One (UNI) at 1 site in Australia.
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 4 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 9 Feb 2026. 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 Australia. 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?
Incidence of Treatment-Emergent Adverse Events (time frame: 165 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 9 Feb 2026.