A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva

NCT05299073 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: MB09-A-01-19
• Study Type: interventional
• Target: 257
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, double blind, parallel group, single dose, 3 arm study to investigate and compare the PK, PD, safety and immunogenicity profile of MB09 with EU/US-Xgeva® in healthy male subjects. During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms. Pharmacodynamics, safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• AUC0-last

  Area under the plasma concentration versus time curve from time zero to the last quantifiable concentration

  Day 1 to Day 253

• Cmax

  Maximum observed plasma concentration

  Day 1 to Day 253

Secondary Outcomes (8)

• AUC0-∞

  Day 1 to Day 253

• Tmax

  Day 1 to Day 253

• CL

  Day 1 to Day 253

• t1/2

  Day 1 to Day 253

• Pharmacodynamics (sCTX) AUEC0-253

  Day 1 to Day 253

Study Arms (3)

MB09 (denosumab biosimilar)

EXPERIMENTAL

Sterile vial 120mg/1.7mL, Single dose, 35mg SC

Drug: MB09

US-sourced Xgeva

ACTIVE COMPARATOR

Sterile vial 120mg/1.7mL, Single dose, 35mg SC

Drug: US-sourced Xgeva

EU-sourced Xgeva

ACTIVE COMPARATOR

Sterile vial 120mg/1.7mL, Single dose, 35mg SC

Drug: EU-sourced Xgeva

Interventions

MB09 DRUG

Single dose of 35mg SC administered

Also known as: denosumab biosimilar

MB09 (denosumab biosimilar)

US-sourced Xgeva DRUG

Single dose of 35mg SC administered

Also known as: US-licensed Xgeva

US-sourced Xgeva

EU-sourced Xgeva DRUG

Single dose of 35mg SC administered

Also known as: EU-licensed Xgeva

EU-sourced Xgeva

Eligibility Criteria

• Age: 28 Years - 55 Years
• Gender Eligibility Details: Only male subjects may be enrolled
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The subject is a male of any race, between 28 and 55 years of age, inclusive, at screening.
• The subject has a BMI between 18.5 and 29.9 kg/m2, inclusive, (total body weight between 60 and 95 kg, inclusive) at screening and check-in.
• The subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results (congenital nonhaemolytic hyperbilirubinemia \[eg, Gilbert's syndrome\] is acceptable), vital sign measurements (systolic BP ≥90 mm Hg and ≤140 mm Hg, diastolic BP ≥50 mm Hg and ≤90 mm Hg), 12 lead ECG results, and physical examination findings at screening and check in.
• The subject must use an adequate method of contraception (eg, condom) or be willing to practice sexual abstinence during the study starting from the day of dosing and for 140 days after dosing. The subject must agree to not donating sperm during the study and for at least 140 days after dosing. Participating subject's female partner of childbearing potential should use an additional form of contraception such as an intra uterine device, barrier method with spermicide, oral contraceptive, injectable progesterone, or sub-dermal implant starting from the male partner's day of dosing until at least 140 days after dosing. The female partner of the participating subject should be familiar with the use of the respective contraceptive methods. Intra-uterine devices and hormonal methods for contraception should be used for at least 1 menstruation cycle prior to the administration of study drug.
• The subject must be able to comprehend and willing to sign an ICF and to abide by the study restrictions. Subjects must have signed an ICF before any study-related procedure or evaluation is performed.

You may not qualify if:

• The subject has had previous exposure to denosumab.
• The subject has a significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator.
• The subject has a history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator.
• The subject has any current or recent history of infections, including localised infections (within 2 months prior to screening for any serious infection that requires hospitalisation or IV anti-infective or within 14 days prior to screening for any active infection which requires oral treatment).
• The subject has a dental or jaw disease requiring oral surgery or dental surgery within 6 months prior to study product administration or plans to have dental surgery within 6 months after dosing.
• The subject has a history of osteomyelitis or osteonecrosis of the jaw requiring suturing within 30 days before dosing, or within 30 days after the last study visit.
• The subject has a medically significant dental disease or dental neglect, with signs and/or symptoms of local or systemic infection that would likely require a dental procedure during the course of the study. Standard dentistry treatments (eg, dental filling or prophylaxis/cleaning) are allowed.
• The subject has clinically relevant history of alcoholism, addiction or drug/chemical abuse prior to check in, and/or positive urinary test for alcohol or drugs of abuse at screening or check in.
• The subject has positive hepatitis panel (HBV and HCV) or positive HIV test. Subjects whose results are compatible with prior immunisation and not infection may be included at the discretion of the investigator.
• The subject has participated in a clinical study involving administration of an investigational drug (new chemical entity), with dosing in the past 90 days prior to Day 1, or within 5 half-lives of the investigational drug used in the study, whichever is longer.
• The subject has used or intends to use slow-release medications/products considered to still be active within 30 days prior to check in, unless deemed acceptable by the investigator.
• The subject has used or intends to use any nonprescription medications/products (except paracetamol \[up to 2 g/day\] and ibuprofen \[800 mg/day\]), including vitamins, minerals, supplements (eg, Biotin), and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to check in, unless deemed acceptable by the investigator. Vitamin C, vitamin D, and calcium in daily recommended doses (≤1000 mg elemental calcium and 1000 IU vitamin D based on screening levels of vitamin D) are allowed.
• The subject has received the COVID-19 vaccine within 14 days before Day 1 or plans to receive a COVID-19 vaccine within 12 weeks after study drug dosing or has positive test for COVID 19 during screening or presence of COVID 19 symptoms within 4 weeks prior to Day -1.
• The subject has received a live or attenuated vaccine within 3 months prior to screening or has the intention to receive a vaccine during the study. The subject intends to travel to a region where a vaccination will be required due to endemic disease during the study.
• The subject has used tobacco- or nicotine-containing products within 1 year prior to check-in or anytime during the study, or has a positive cotinine test upon screening or check-in.

Sponsors & Collaborators

• mAbxience Research S.L.: lead

Study Sites (1)

Biokinetica - Early Phase Institute

Józefów, Poland

Location

MeSH Terms

Interventions

QL1206

Results Point of Contact

• Title: Susan Millan PhD
• Organization: mAbxience Research S.L.U.

susana.millan@mabxience.com

+34 917711500

Study Officials

• Monika Tomaszewska-Kiecana, MD

  Biokinetica S.A.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 28, 2022
• Study Start: March 1, 2022
• Primary Completion: March 18, 2023
• Study Completion: March 18, 2023
• Last Updated: January 3, 2025
• Results First Posted: January 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)