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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05405985
• Other study ID #: RD.06.SPR.201590
• Status: Completed
• Phase: Phase 1
• Start date: August 11, 2022
• Est. completion date: December 8, 2022

Study information

• Verified date: May 2022
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: December 8, 2022
• Est. primary completion date: November 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male and female participants aged 18 to 65 years at screening visit.

• Body weight = 45 kg and body mass index between =18.0 and <30.0 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 are not believed to affect subject's safety or the overall results of the study may 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.

• Understand and sign and informed consent form before any investigational procedure(s) are performed.

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Nemolizumab
Nemolizumab with Auto-Injector (AI).
• Nemolizumab
Nemolizumab with Dual-Chamber Syringe (DCS).

Locations

Country	Name	City	State
United States	Galderma Investigational Site 7023	Lincoln	Nebraska
United States	Galderma Investigational Site 7024	Tempe	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Observed Maximum Serum Concentration (Cmax) of Nemolizumab Administered With Auto-Injector (AI)		From Baseline up to Week 12
Primary	Change in Observed Maximum Serum Concentration (Cmax) of Nemolizumab Administered With Dual-Chamber Syringe (DCS)		From Baseline up to Week 12
Primary	Change in Area under Concentration-time Curve Extrapolated to Infinity (AUC 0-inf) of Nemolizumab Administered With AI (Auto-Injector)		From Baseline up to Week 12
Primary	Change in Area under Concentration-time Curve Extrapolated to Infinity (AUC 0-inf) of Nemolizumab Administered With Dual-Chamber Syringe (DCS)		From Baseline up to Week 12
Secondary	Change in Area Under the Concentration-time Curve Over the Specified Interval (AUC 0-4 weeks) of Nemolizumab Administered With Auto-Injector (AI)		From Baseline up to Week 12
Secondary	Change in Area Under Concentration-time Curve From Administration to the Last Observed Concentration Time t (AUC 0-last) of Nemolizumab Administered With Auto-Injector (AI)		From Baseline up to Week 12
Secondary	Change in T max (Time to Achieve C max) of Nemolizumab Administered With Auto-Injector (AI)		From Baseline up to Week 12
Secondary	Change in t 1/2 (Half-life) of Nemolizumab Administered With Auto-Injector (AI)		From Baseline up to Week 12
Secondary	Change in Area Under the Concentration-Time Curve Over the Specified Interval (AUC 0-4 weeks) Nemolizumab Administered With Dual-Chamber Syringe (DCS)		From Baseline up to Week 12
Secondary	Change in Area Under Concentration-time Curve From Administration to the Last Observed Concentration Time t (AUC 0-last) of Nemolizumab Administered With Dual-Chamber Syringe (DCS)		From Baseline up to Week 12
Secondary	Change in T max (Time to Achieve C max) of Nemolizumab Administered With Dual-Chamber Syringe (DCS)		From Baseline up to Week 12
Secondary	Change in t 1/2 (Half-life) of Nemolizumab When Administered With Dual-Chamber Syringe (DCS)		From Baseline up to Week 12
Secondary	Assessment of the Immunogenicity (anti-drug antibodies, ADA) of Nemolizumab Administered With Auto-Injector (AI)		From Baseline up to Week 12
Secondary	Assessment of the Immunogenicity (anti-drug antibodies, ADA) of Nemolizumab Administered With Dual-Chamber Syringe (DCS)		From Baseline up to Week 12
Secondary	Number of participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)		From Baseline up to Week 12