A PK Study Comparing MB05, EU-sourced Synagis® and US-sourced Synagis® in Healthy Volunteers.

NCT05121246 | Completed Phase 1 Results

• 1 other identifier: MB05-A-01-21
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 3

Brief Summary

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. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• Comparison of the Pharmacokinetic (PK) Profiles Between MB05 and EU-Synagis®, Between MB05 and US-Synagis® and Between EU-Synagis® and US-Synagis® in Terms of Area Under the Serum Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf)

  Bioequivalence between MB05 and EU Synagis®, between MB05 and US-Synagis® and between EU-Synagis® and US-Synagis® will be investigated for AUC0-inf and Cmax by analysis of variance using log-transformed PK parameter values. Bioequivalence will be assessed by calculating the 90% CIs for the ratio of the least squares geometric means for each pairwise comparison and each PK parameter. Bioequivalence will be concluded where the 90% CIs for the ratio of least squares geometric means are contained within the range 80.00% to 125.00%. Blood samples collection timepoints: pre-dose (within 60 minutes prior); 4 hr (+/- 15 min); 12 hr (+/- 15 min); 24 hr (+/- 1 hr); 48 hr (+/- 5 hr); 72 hr (+/- 5 hr); 96 hr (+/- 5 hr); 120 hr (+/- 5 hr); 168 hr (+/- 5 hr) post-dose, and then at Days 15; 22; 29; 36; 43; 57; 71; 85; and 99 (end of study).

  Day 1 - Day 100

• Compare the Pharmacokinetic (PK) Profiles Between MB05 and EU-Synagis®, Between MB05 and US-Synagis® and Between EU-Synagis® and US-Synagis® in Terms of Maximum Observed Serum Concentration Cmax.

  Bioequivalence between MB05 and EU Synagis®, between MB05 and US-Synagis® and between EU-Synagis® and US-Synagis® will be investigated for AUC0-inf and Cmax by analysis of variance using log-transformed PK parameter values. Bioequivalence will be assessed by calculating the 90% CIs for the ratio of the least squares geometric means for each pairwise comparison and each PK parameter. Bioequivalence will be concluded where the 90% CIs for the ratio of least squares geometric means are contained within the range 80.00% to 125.00%. Blood samples collection timepoints: pre-dose (within 60 minutes prior); 4 hr (+/- 15 min); 12 hr (+/- 15 min); 24 hr (+/- 1 hr); 48 hr (+/- 5 hr); 72 hr (+/- 5 hr); 96 hr (+/- 5 hr); 120 hr (+/- 5 hr); 168 hr (+/- 5 hr) post-dose, and then at Days 15; 22; 29; 36; 43; 57; 71; 85; and 99 (end of study).

  Day 1 - Day 100

• Pharmacokinetics (PK)- (AUC0-inf)

  Pharmacokinetic (PK) profiles for each arm (AUC0-inf)

  Day 1 - Day 100

• Pharmacokinetics (PK) - (Cmax)

  Pharmacokinetic (PK) profiles for each arm (Cmax)

  Day 1 - Day 100

Secondary Outcomes (6)

• Tmax

  Day 1 - Day 100

• t1/2

  Day 1 - Day 100

• Vz

  Day 1- Day 100

• CL

  Day 1- Day 100

• Safety and Tolerability

  Day 1- Day 100

Study Arms (3)

MB05 (Proposed palivizumab biosimilar)

EXPERIMENTAL

Sterile vial 100mg/1ml, single-dose 3mg/kg administered as intramuscular injection on day 1.

Drug: MB05 (Proposed palivizumab biosimilar)

EU-Synagis®

ACTIVE COMPARATOR

Sterile vial 100mg/1ml, single-dose 3mg/kg administered as intramuscular injection on day 1

Drug: EU-Synagis®

US-Synagis®

ACTIVE COMPARATOR

Sterile vial 100mg/1ml, single-dose 3mg/kg administered as intramuscular injection on day 1

Drug: US-Synagis®

Interventions

MB05 (Proposed palivizumab biosimilar) DRUG

Single IM dose of 3 mg/kg

MB05 (Proposed palivizumab biosimilar)

EU-Synagis® DRUG

Single IM dose of 3 mg/kg

EU-Synagis®

US-Synagis® DRUG

Single IM dose of 3 mg/kg

US-Synagis®

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers will be included in the study if they meet all of the following criteria at screening, and after check-in on Day -1 (prior to dose administration on Day 1):
• Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
• Adult male and female volunteers, 18 to 55 years of age (inclusive).
• Body mass index (calculated) within the range of 18 to 30 kg/m2 inclusive and total body weight between 50 and 95 kg, inclusive, at screening and check-in.
• Medically healthy without clinically significant abnormalities, including:
• Physical examination without any clinically significant findings, in the opinion of the Investigator.
• Systolic blood pressure (BP) in the range of 90 to 145 mm Hg (inclusive) and diastolic BP in the range of 50 to 90 mm Hg (inclusive) after at least 5 minutes in the supine position.
• Pulse rate (PR) in the range of 40 to 100 beats/min (inclusive) after at least 5 minutes rest in a supine position.
• Normal body temperature 35.1 to 37.6°C (inclusive) (Tympanic temperature).
• Triplicate 12-lead electrocardiogram (ECG), taken after the volunteer has been supine for at least 5 minutes, with a QT interval corrected using the Fridericia method (QTcF) ≤ 450 msec for males and ≤ 470 msec for females and no clinically significant abnormalities, in the opinion of the Investigator.
• Adequate bone marrow function defined by absolute neutrophil count, platelet count and haemoglobin levels within normal ranges (per local laboratory standard).
• Adequate liver function as defined by:
• Alanine aminotransferase (ALT) aspartate aminotransferase (AST), alkaline phosphatase (ALP) and bilirubin ≤ 1.5 x upper limit of normal (ULN). Note: Bilirubin \> 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is \< 35%.
• Adequate coagulation, as defined by:
• Prothrombin time (PT) / International Normalised Ratio (INR), thrombin time (TT), or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN.

You may not qualify if:

• Healthy volunteers will be excluded from the study if there is evidence of any of the following at screening or any time after check-in on Day -1 (prior to dose administration on Day 1):
• Prior exposure to Synagis® (palivizumab).
• Have a history of hypersensitivity or allergic reactions (either spontaneous or following drug administration) to any drug compound or its excipients, food, or other substance. Minor (non-anaphylactic) reactions to food substances (non-excipients) may be permitted, at the discretion of the Investigator.
• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, deemed to be clinically relevant as determined by the Investigator (or designee).
• Presence or evidence of recent sunburn, scar tissue, tattoo (more than 25% of body area), open sore or branding that, in the opinion of the Investigator, would interfere with interpretation of skin adverse reactions.
• Have a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or human immunodeficiency virus (HIV). Screening only.
• Have a positive test result for COVID-19 (polymerase chain reaction \[PCR\] or antigen test) within 72 hours prior to dose administration.
• If subject smokes, subject is unwilling to abstain from smoking for 7 days prior to admission and during the confinement period.
• Positive serum pregnancy test for women of childbearing potential (WOCBP) at the screening visit or positive urine pregnancy test with confirmatory serum pregnancy test prior to dosing on Day 1.
• Females who are breastfeeding.
• Have a history of cancer including lymphoma, leukaemia and skin cancer (volunteers with surgically resected basal cell carcinoma or squamous cell carcinomas are permitted).
• Have an illness within 30 days prior to screening, or prior to dosing, that is classed as clinically significant by the Investigator.
• Any clinically significant infection, in the opinion of the Investigator, ongoing at screening or admission to the clinical unit.
• Prior exposure to any investigational monoclonal antibody within 6 months or 5 half-lives of the previous drug (if known), whichever is longer, prior to study drug administration.
• Have been dosed in another clinical study with an investigational drug (excluding monoclonal antibody) within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to the administration of the study drug or are currently participating in another clinical study of an investigational drug or intending to participate in another clinical study of an investigational drug before completion of all scheduled evaluations in this clinical study.

Sponsors & Collaborators

• mAbxience Research S.L.: lead

Study Sites (3)

Nucleus Network. Q-Pharm Pty Ltd

Brisbane, Queensland, 4006, Australia

Location

New Zealand Clinical Research Ltd.

Auckland, 1010, New Zealand

Location

New Zealand Clinical Research Ltd.

Christchurch, 8011, New Zealand

Location

Results Point of Contact

• Title: Dr. Susana Millán
• Organization: mAbxience Research S.L.U.

susana.millan@mabxience.com

+34 682821346

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: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2021
• First Posted: November 16, 2021
• Study Start: June 15, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: April 2, 2025
• Results First Posted: April 2, 2025

Record last verified: 2023-09

Locations

AU (1); NZ (2)