Healthy VolunteersPhase 1NCT05405985

Study to Access the Relative Bioavailability of Subcutaneous Dose of Nemolizumab When Administered Via Auto-Injector Versus Dual-Chamber Syringe

A Phase 1 study testing Nemolizumab in people with Healthy Volunteers, run by Galderma R&D at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study was to compare the rate and extent of absorption of a single dose of nemolizumab administered with auto-injectors [AI] (test) versus dual-chamber syringes [DCS] (reference) under controlled conditions in healthy adult subjects. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Nemolizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 192 participants
Where: 2 sitesUnited States
Study dates: 11 Aug 2022to 8 Dec 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Male and female participants aged 18 to 65 years at screening visit.
Body weight >= 45 kilogram (kg) and body mass index between >=18.0 and <30.0 kilograms per meter squared (kg/m^2) at both screening and baseline visits.
Medically healthy with normal clinical status as judged by the investigator based on medical history, physical examination, and clinical laboratory tests.
Willing to abstain from all prescription medications during the study, (defined hereafter as after signing of informed consent form), except to treat AEs and contraception, and as permitted under Exclusion 2. Limited use of non-prescription medications/supplements that were not believed to affect participant's safety or the overall results of the study might be permitted at the discretion of investigator.
Female participants of childbearing potential (i.e., fertile, after menarche and, until becoming postmenopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the study drug injection, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the study drug injection. Males are not required to use contraception, and there is no restriction on sperm donation.
Female participants of non-childbearing potential must meet one of these criteria; absence of menstrual bleeding for 1 year before the screening visit with no other medical reason, confirmed with follicle-stimulating hormone (FSH) level in the postmenopausal range or documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy at least 3 months before the study.
Willing and able to comply with all of the time commitments and procedural requirements of the clinical study protocol.
Understood and signed an informed consent form before any investigational procedure(s) are performed.

Who cannot join

History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, e.g., monoclonal antibody) or to any of the study drug excipients.
Cutaneous infection within 1 week before the baseline visit or any infection requiring treatment with oral, parental antibodies, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit.
Any confirmed or suspected coronavirus disease (COVID-19) infection within 2 weeks before screening or baseline visit.
Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb], hepatitis C [HCV] antibody with positive HCV RNA, or human immunodeficiency virus [HIV] antibody) at the screening visit.
Known or suspected immunosuppression or unusually frequent, recurrent, severe, or prolonged infections as per investigator judgment.
History of lymphoproliferative disease or history of malignancy of any organ system within last 5 years, except for basal cell carcinoma, squamous cell carcinoma in situ (Bowen's disease), or carcinomas in situ of the cervix that have been treated and have no clinical evidence of recurrence in the last 12 weeks before baseline visit, or actinic keratoses that have been treated.

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Previous treatment with Nemolizumab.
Known active or untreated latent tuberculosis infection.
Any condition that may interfere with study assessments (e.g., poor venous access or needle phobia).
Having received a live-attenuated or non-live vaccine within 4 weeks before the baseline visit or are expected to be vaccinated during the study or during the 12 weeks after the last study drug injection, except for non-live seasonal vaccinations, COVID-19 and /or emergency vaccinations.
Planned or expected major surgical procedure during the clinical study.
Pregnant women, breastfeeding women, or women planning a pregnancy during the study or 12 weeks after the study drug injection.
Participating or participated in any other study with an investigational drug or device within the past 8 weeks before the screening visit, or is in an exclusion period from a previous study.
Participants who have donated ≥ 500 mL of blood in the last 3 months before doing.
History of alcohol or substance abuse within 6 months of the screening visit.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Galderma Investigational Site 7023
Lincoln, Nebraska, 68502
Galderma Investigational Site 7024
Tempe, Arizona, 85283

Other trials in United States

About this study

Official title: A Randomized, Single-Dose, Open-Label, Parallel-Group Study in Healthy Volunteers to Assess the Relative Bioavailability of a Subcutaneous Dose of Nemolizumab When Administered With Auto-Injector Compared to Dual-Chamber Syringe

Conditions: Healthy Volunteers
Being tested: Nemolizumab
Keywords: Auto-Injector (AI), Dual-Chamber Syringe (DCS), Atopic dermatitis (AD), Prurigo nodularis (PN)
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NemolizumabDrug
Nemolizumab with Auto-Injector (AI).
NemolizumabDrug
Nemolizumab with Dual-Chamber Syringe (DCS).

Study groups in NCT05405985
Study group	Role	What they receive
Nemolizumab With Auto-Injector (AI)	Experimental	Participants received a 60 milligrams (mg) dose of nemolizumab as 2 successive subcutaneous (SC) injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 centimeters [cm]) apart with AI on Day 0 (injection day). Receives: Drug: Nemolizumab
Nemolizumab With Dual Chamber Syringe (DCS)	Experimental	Participants received a 60-mg dose of nemolizumab as 2 successive subcutaneous injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with DCS on Day 0 (injection day). Receives: Drug: Nemolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of Nemolizumab
Cmax was defined as the observed maximum serum concentration of nemolizumab. Cmax was used to measure the rate of absorption of nemolizumab.
Measured: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
Area Under Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Nemolizumab
AUC0-inf was defined as area under the plasma concentration-time curve from time 0 to infinity according to the equation: AUC0-inf = AUClast + Clast/λz; where λz = slope of the regression line of the terminal phase of the plasma concentration versus time curve, in semi-logarithmic scale; and Clast = last measurable drug concentration.
Measured: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose

Secondary outcomes (5)

Area Under the Concentration-time Curve Over the Specified Interval (AUC0-4 Weeks) of Nemolizumab
AUC0-4 weeks was defined as area under the concentration-time curve from time 0 to 4 weeks after study drug administration calculated with the linear trapezoidal method.
Measured: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22 and 29 post-dose
Area Under Concentration-time Curve From Administration to the Last Observed Concentration Time t (AUC0-last) of Nemolizumab
AUC0-last was defined as area under the concentration-time curve from administration to the last observed concentration time t, calculated with the linear trapezoidal method.
Measured: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
Time to Reach Maximum Observed Serum Concentration (Tmax) of Nemolizumab
Tmax was defined as the time taken to reach the maximum observed serum concentration.
Measured: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
Half-life (t1/2) of Nemolizumab
t1/2 is defined as time required for the concentration of the drug to reach half of its original value.
Measured: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
Number of Participants With Positive Anti-drug Antibodies (ADA) Response Against Nemolizumab
ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result.
Measured: Pre-dose, Day 29 and 85 post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Aug 20228 Dec 2022

First posted6 Jun 2022
Study start11 Aug 2022
Primary completion11 Nov 2022
Study completion8 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Galderma R&DThe sponsor's other registered studies.
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: None (open label)
Enrolment: 192 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05405985
Sponsor's protocol ID: RD.06.SPR.201590
Status last verified: Nov 2024
First submitted: 1 Jun 2022
Last updated: 3 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Single-Dose, Open-Label, Parallel-Group Study in Healthy Volunteers to Assess the Relative Bioavailability of a Subcutaneous Dose of Nemolizumab When Administered With Auto-Injector Compared to Dual-Chamber Syringe
ClinicalTrials.gov ID: NCT05405985
Acronym / sponsor ID: RD.06.SPR.201590
Conditions: Healthy Volunteers
Keywords: Auto-Injector (AI), Dual-Chamber Syringe (DCS), Atopic dermatitis (AD), Prurigo nodularis (PN)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 192 participants (actual)
Lead sponsor: Galderma R&DIndustry (pharma, biotech, devices)
Study start: 11 Aug 2022 (actual)
Primary completion: 11 Nov 2022 (actual)
Study completion: 8 Dec 2022 (actual)
First posted: 6 Jun 2022 (actual)
Results: Posted 3 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Nemolizumab With Auto-Injector (AI)	Experimental	Drug: NemolizumabParticipants received a 60 milligrams (mg) dose of nemolizumab as 2 successive subcutaneous (SC) injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 centimeters [cm]) apart with AI on Day 0 (injection day).
Nemolizumab With Dual Chamber Syringe (DCS)	Experimental	Drug: NemolizumabParticipants received a 60-mg dose of nemolizumab as 2 successive subcutaneous injections of 30 mg nemolizumab at either of the same location i.e., abdomen, front upper thigh, or outer upper arm and on the same side with injection sites at least 1 inch (2.5 cm) apart with DCS on Day 0 (injection day).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male and female participants aged 18 to 65 years at screening visit.
Body weight >= 45 kilogram (kg) and body mass index between >=18.0 and <30.0 kilograms per meter squared (kg/m^2) at both screening and baseline visits.
Medically healthy with normal clinical status as judged by the investigator based on medical history, physical examination, and clinical laboratory tests.
Willing to abstain from all prescription medications during the study, (defined hereafter as after signing of informed consent form), except to treat AEs and contraception, and as permitted under Exclusion 2. Limited use of non-prescription medications/supplements that were not believed to affect participant's safety or the overall results of the study might be permitted at the discretion of investigator.
Female participants of childbearing potential (i.e., fertile, after menarche and, until becoming postmenopausal unless permanently sterile) must agree either to be strictly abstinent throughout the study and for 12 weeks after the study drug injection, or to use an adequate and approved method of contraception throughout the study and for 12 weeks after the study drug injection. Males are not required to use contraception, and there is no restriction on sperm donation.

Key exclusion criteria (15 listed)

History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, e.g., monoclonal antibody) or to any of the study drug excipients.
Cutaneous infection within 1 week before the baseline visit or any infection requiring treatment with oral, parental antibodies, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit.
Any confirmed or suspected coronavirus disease (COVID-19) infection within 2 weeks before screening or baseline visit.
Positive serology results (hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb], hepatitis C [HCV] antibody with positive HCV RNA, or human immunodeficiency virus [HIV] antibody) at the screening visit.
Known or suspected immunosuppression or unusually frequent, recurrent, severe, or prolonged infections as per investigator judgment.

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
NemolizumabNemolizumab with Auto-Injector (AI).	Drug	Nemolizumab With Auto-Injector (AI)
NemolizumabNemolizumab with Dual-Chamber Syringe (DCS).	Drug	Nemolizumab With Dual Chamber Syringe (DCS)

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Nemolizumab
Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
Cmax was defined as the observed maximum serum concentration of nemolizumab. Cmax was used to measure the rate of absorption of nemolizumab.
Area Under Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Nemolizumab
Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
AUC0-inf was defined as area under the plasma concentration-time curve from time 0 to infinity according to the equation: AUC0-inf = AUClast + Clast/λz; where λz = slope of the regression line of the terminal phase of the plasma concentration versus time curve, in semi-logarithmic scale; and Clast = last measurable drug concentration.

5 secondary outcomes

Area Under the Concentration-time Curve Over the Specified Interval (AUC0-4 Weeks) of Nemolizumab
Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22 and 29 post-dose
Area Under Concentration-time Curve From Administration to the Last Observed Concentration Time t (AUC0-last) of Nemolizumab
Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
Time to Reach Maximum Observed Serum Concentration (Tmax) of Nemolizumab
Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
Half-life (t1/2) of Nemolizumab
Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
Number of Participants With Positive Anti-drug Antibodies (ADA) Response Against Nemolizumab
Time frame: Pre-dose, Day 29 and 85 post-dose

Results and safety

Results posted to the registry on 3 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nemolizumab With Auto-Injector (AI)	96	95
Nemolizumab With Dual Chamber Syringe (DCS)	96	96

Primary outcome: Maximum Observed Plasma Concentration (Cmax) of Nemolizumab

Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose. Mean (Standard Deviation). Unit: micrograms per milliliter (mcg/mL)

Measure	Nemolizumab With AI n = 96	Nemolizumab With DCS n = 96
Value	8.00 (2.34)	7.51 (2.31)

Population analysed: Analysis was performed on pharmacokinetics (PK) population which included all randomized participants who received the dose of nemolizumab and provided evaluable data that can be used for the PK analyses.

Primary outcome: Area Under Concentration-time Curve Extrapolated to Infinity (AUC0-inf) of Nemolizumab

Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose. Mean (Standard Deviation). Unit: micrograms*day per milliliter

Measure	Nemolizumab With AI n = 95	Nemolizumab With DCS n = 96
Value	270 (85.8)	279 (89.7)

Population analysed: Analysis was performed on PK population which included all randomized participants who received the dose of nemolizumab and provided evaluable data that can be used for the PK analyses. Here, 'overall number of participants analyzed, N' signifies participants who were evaluable for this outcome measure.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Baseline up to Week 12. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nemolizumab With AI	0 of 96 (0%)	41 of 96 (42.7%)	0 of 96
Nemolizumab With DCS	0 of 96 (0%)	54 of 96 (56.3%)	0 of 96

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nemolizumab in people with Healthy Volunteers, run by Galderma R&D at 2 sites 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 8 inclusion and 15 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 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 3 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Observed Plasma Concentration (Cmax) of Nemolizumab (time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05405985.

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 3 Jan 2025.