Relative BioequivalencePhase 1NCT06994936
An Open-label Study in Healthy Adults to Evaluate the Relative Bioequivalence of a Single-dose Administration of Sonelokimab Either by a Prefilled Syringe or an Autoinjector
A Phase 1 study testing Sonelokimab in people with Relative Bioequivalence, run by MoonLake Immunotherapeutics AG at 1 site in United Kingdom.
Trial summary
This is a study to confirm the relative bioequivalence of sonelokimab administered subcutaneously via a prefilled syringe (PFS) or an autoinjector (AI) in healthy adult volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Relative Bioequivalence
- What is being tested?
- Sonelokimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jun 2025to 1 Nov 2025
- 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
- Participants must be between 18 and 55 years of age with suitable veins for cannulation or repeated venipuncture .
- Participants must have a body weight greater than 40 kg and body mass index (BMI) between 21 and 30 kg/m2, inclusive.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physician examination, laboratory tests, and cardiac monitoring.
- Female participants are eligible to participate if they are not pregnant or breastfeeding
- Male participants must be willing to use a condom when sexually active with a partner of childbearing potential during the study, unless surgically sterile.
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- History of clinically significant infections.
- Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric.
- History of hypersensitivity, intolerance, or severe adverse reaction to any drug compound, any history of anaphylaxis or angioedema, or any history of severe food allergy/intolerance requiring systemic treatment.
- Participants with transaminase and liver function test results outside of the normal reference range, following a confirmatory test, if appropriate
- Participants with other clinically significant laboratory test results that are likely to introduce additional risk factors or interfere with the study procedures or interpretation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Parallel-group, Single-dose Relative Bioequivalence Study of Sonelokimab Administered Subcutaneously Either by a Prefilled Syringe or an Autoinjector in Healthy Adults
This is a study to confirm the relative bioequivalence of sonelokimab administered subcutaneously via a prefilled syringe (PFS) or an autoinjector (AI) in healthy adult volunteers
- Conditions
- Relative Bioequivalence
- Being tested
- Sonelokimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonelokimabDrug
sonelokimab 120 mg administered subcutaneously via a PFS
SonelokimabDrug
sonelokimab 120 mg administered subcutaneously via an AI
| Study group | Role | What they receive |
|---|---|---|
| Sonelokimab via a PFS | Experimental | Not described Receives: Drug: Sonelokimab |
| Sonelokimab via an AI | Experimental | Not described Receives: Drug: Sonelokimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of pharmacokinetics (PK) of an AI versus PFS administered single dose of sonelokimab
To compare the PK of an AI versus PFS administered single-dose of sonelokimab in terms of maximum concentration (Cmax)
Measured: 64 days
Comparison of pharmacokinetics (PK) of an AI versus PFS administered single dose of sonelokimab
To compare the PK of an AI versus PFS administered single-dose of sonelokimab in terms of area under the time concentration curve to infinite time (AUC0-inf)
Measured: 64 days
Comparison of pharmacokinetics (PK) of an AI versus PFS administered single dose of sonelokimab
To compare the PK of an AI versus PFS administered single-dose of sonelokimab in terms of area under the time concentration curve from time zero to timepoint with last measurable concentration (AUC0-t)
Measured: 64 days
Secondary outcomes (5)
Assessment of safety and tolerability
To assess the safety and tolerability of AI and PFS administered sonelokimab by treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)
Measured: 64 days
Evaluation of the impact of injection site location on PK
Evaluation of the impact of injection site location on PK by capturing the relative bioavailability (F%) for thigh injection of sonelokimab compared to abdomen
Measured: 64 days
Evaluation of the impact of injection site location on PK
Evaluation of the impact of injection site location on PK by capturing the relative bioavailability (F%) for upper-arm injection of sonelokimab compared to abdomen
Measured: 64 days
Evaluation of the impact of injection site location on PK
Evaluation of the impact of injection site location on PK by capturing the relative bioavailability (F%) for thigh injection of sonelokimab compared to upper arm
Measured: 64 days
Immunogenicity of sonelokimab
Description of the prevalence of antidrug antibodies (ADAs)
Measured: 64 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start5 Jun 2025
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relative BioequivalenceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- MoonLake Immunotherapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994936
- Sponsor's protocol ID
- M1095-HV-102
- Status last verified
- Dec 2025
- First submitted
- 20 May 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Parallel-group, Single-dose Relative Bioequivalence Study of Sonelokimab Administered Subcutaneously Either by a Prefilled Syringe or an Autoinjector in Healthy Adults
- ClinicalTrials.gov ID
- NCT06994936
- Acronym / sponsor ID
- M1095-HV-102
- Conditions
- Relative Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- MoonLake Immunotherapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 29 May 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.
This is a study to confirm the relative bioequivalence of sonelokimab administered subcutaneously via a prefilled syringe (PFS) or an autoinjector (AI) in healthy adult volunteers
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sonelokimab via a PFS | Experimental | Drug: Sonelokimab |
| Sonelokimab via an AI | Experimental | Drug: Sonelokimab |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants must be between 18 and 55 years of age with suitable veins for cannulation or repeated venipuncture .
- Participants must have a body weight greater than 40 kg and body mass index (BMI) between 21 and 30 kg/m2, inclusive.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physician examination, laboratory tests, and cardiac monitoring.
- Female participants are eligible to participate if they are not pregnant or breastfeeding
- Male participants must be willing to use a condom when sexually active with a partner of childbearing potential during the study, unless surgically sterile.
Key exclusion criteria (6 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- History of clinically significant infections.
- Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric.
- History of hypersensitivity, intolerance, or severe adverse reaction to any drug compound, any history of anaphylaxis or angioedema, or any history of severe food allergy/intolerance requiring systemic treatment.
- Participants with transaminase and liver function test results outside of the normal reference range, following a confirmatory test, if appropriate
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 |
|---|---|---|
| Sonelokimabsonelokimab 120 mg administered subcutaneously via a PFS | Drug | Sonelokimab via a PFS |
| Sonelokimabsonelokimab 120 mg administered subcutaneously via an AI | Drug | Sonelokimab via an AI |
Primary outcome
Comparison of pharmacokinetics (PK) of an AI versus PFS administered single dose of sonelokimab
Time frame: 64 days
To compare the PK of an AI versus PFS administered single-dose of sonelokimab in terms of maximum concentration (Cmax)
Comparison of pharmacokinetics (PK) of an AI versus PFS administered single dose of sonelokimab
Time frame: 64 days
To compare the PK of an AI versus PFS administered single-dose of sonelokimab in terms of area under the time concentration curve to infinite time (AUC0-inf)
Comparison of pharmacokinetics (PK) of an AI versus PFS administered single dose of sonelokimab
Time frame: 64 days
To compare the PK of an AI versus PFS administered single-dose of sonelokimab in terms of area under the time concentration curve from time zero to timepoint with last measurable concentration (AUC0-t)
5 secondary outcomes
Assessment of safety and tolerability
Time frame: 64 days
Evaluation of the impact of injection site location on PK
Time frame: 64 days
Evaluation of the impact of injection site location on PK
Time frame: 64 days
Evaluation of the impact of injection site location on PK
Time frame: 64 days
Immunogenicity of sonelokimab
Time frame: 64 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 Dec 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.
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 Sonelokimab in people with Relative Bioequivalence, run by MoonLake Immunotherapeutics AG at 1 site in United Kingdom.
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 6 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 Dec 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 Kingdom. 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?
Comparison of pharmacokinetics (PK) of an AI versus PFS administered single dose of sonelokimab (time frame: 64 days). 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 9 Dec 2025.