Healthy VolunteersPhase 1FANTASYNCT05121246
A PK Study Comparing MB05, EU-sourced Synagis® and US-sourced Synagis® in Healthy Volunteers.
A Phase 1 study testing MB05 (Proposed palivizumab biosimilar), EU-Synagis® and US-Synagis® in people with Healthy Volunteers, run by mAbxience Research S.L. at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- MB05 (Proposed palivizumab biosimilar), EU-Synagis® and US-Synagis®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 Jun 2022to 31 Mar 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
- Adequate renal function, as defined by:
- Creatinine or measured or calculated creatinine clearance ≤ 1.5 x ULN. Note. Glomerular filtration rate (GFR) can be used in place of creatinine or CrCl.
- No other clinically significant findings in serum chemistry, haematology, coagulation and urinalysis examinations, in the opinion of the Investigator.
- Note. The above assessments may be repeated once, if abnormal values were recorded in the first instance, at the discretion of the Investigator.
- No prior history of chronic alcohol abuse or excessive alcohol intake, at the discretion of the PI, within 12 weeks prior to screening, and negative alcohol test results (at screening and on Day -1). Excessive alcohol intake is defined as regular consumption of > 12 standard units of alcohol per week, or more than 4 standard drinks on > 3 days per week, where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% Alc./Vol], 100 mL wine [12% Alc./Vol], 30 mL spirit [40% Alc./Vol]).
- No prior history of substance abuse or drug addiction within 12 months prior to first study drug administration and negative drug test results (at screening and on Day -1).
- Female volunteers must:
- Be of non-childbearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the Screening visit) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone [FSH] level indicative of postmenopausal status per local laboratory definition), OR
- If of childbearing potential:
- Must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test within 24 hours prior to dose administration on Day 1
- Must not be breastfeeding, lactating or planning pregnancy during the study period
- Must agree not to attempt to become pregnant
- If not exclusively in same-sex relationships, must agree to use adequate contraception (which is defined as use of a condom by the male partner combined with the use of a highly effective method of contraception per APPENDIX 4) from 30 days prior to dosing until at least 190 days after the last dose of study drug.
- Must agree not to donate ova for at least 190 days after the last dose of study drug.
- Male volunteers, must agree not to donate sperm for at least 190 days after the last dose of study drug, and if engaging in sexual intercourse, must agree to:
- use a condom, PLUS
- when engaging in sexual intercourse with a female who may become pregnant, must agree to have the female use an acceptable form of contraception (refer to APPENDIX 4) from 30 days prior to dosing until at least 190 days after the last dose of study drug.
- Have suitable venous access for blood sampling.
- Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Who cannot join
- 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.
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- 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.
- Have had major surgery within 30 days prior to screening or will have an operation between screening and the end of study visit.
- Have donated > 100 mL blood or plasma within 4 weeks prior to the administration of the study drug. Participant must also agree to refrain from donating blood or blood products throughout the duration of the study.
- Use of any prescription or over-the-counter medication (including herbal products, diet aids, and hormone supplements) within 10 days or 5 half-lives of the medication (whichever is longer) prior to the first study drug administration, which, in the opinion of the Investigator, could affect the outcome of the study. The following exceptions apply:
- Contraceptives for WOCBP.
- Paracetamol (up to a maximum of 4 doses of 500 mg per day, and no more than 3g per week).
- Ibuprofen (up to a maximum of 4 doses of 200 mg per day).
- Has received (or plans to receive) a vaccine within the following timeframes:
- Live or attenuated vaccine within 3 months prior to dose administration on Day 1 or plans to receive a live or live attenuated vaccine during the study.
- Other vaccines (including COVID-19 vaccines) within 14 days prior to dose administration on Day 1 or plans to receive other vaccines within 14 days following dose administration on Day 1.
- Any person who is an employee of an Investigator or Sponsor, or an immediate relative of an Investigator.
- Any other condition or prior therapy that in the opinion of the Investigator would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
New Zealand2 sites
New Zealand Clinical Research Ltd.
Auckland, 1010
New Zealand Clinical Research Ltd.
Christchurch, 8011
About this study
Official title: A Randomized, Double-Blind, 3-arm Parallel Study to Compare PK, Safety, IMM and Tolerability of MB05, EU-sourced Synagis® and US-sourced Synagis®, as a Single Dose Intramuscular Injection in Healthy Volunteers.
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.
Read the detailed description
MB05 is being developed as a potential biosimilar to Synagis® for all indications for which Synagis® is approved. This study is designed to demonstrate PK similarity of the proposed biosimilar test product MB05 and the reference products EU- and US-Synagis®.This is a first-in-human study of the Synagis® biosimilar MB05. The reference product ynagis® was first approved by the US Food and Drug Administration (FDA) in 1998 and by the European Medicines agency (EMA) in 1999.
As a proposed biosimilar, the clinical experience with Synagis® (as described in the Synagis® summary of product characteristics) (most recent versions) is deemed applicable to MB05.
- Conditions
- Healthy Volunteers
- Being tested
- MB05 (Proposed palivizumab biosimilar), EU-Synagis®, US-Synagis®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MB05 (Proposed palivizumab biosimilar)Drug
Single IM dose of 3 mg/kg
EU-Synagis®Drug
Single IM dose of 3 mg/kg
US-Synagis®Drug
Single IM dose of 3 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| MB05 (Proposed palivizumab biosimilar) | Experimental | Sterile vial 100mg/1ml, single-dose 3mg/kg administered as intramuscular injection on day 1. Receives: Drug: MB05 (Proposed palivizumab biosimilar) |
| EU-Synagis® | Active comparator | Sterile vial 100mg/1ml, single-dose 3mg/kg administered as intramuscular injection on day 1 Receives: Drug: EU-Synagis® |
| US-Synagis® | Active comparator | Sterile vial 100mg/1ml, single-dose 3mg/kg administered as intramuscular injection on day 1 Receives: Drug: US-Synagis® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Day 1 - Day 100
Pharmacokinetics (PK)- (AUC0-inf)
Pharmacokinetic (PK) profiles for each arm (AUC0-inf)
Measured: Day 1 - Day 100
Pharmacokinetics (PK) - (Cmax)
Pharmacokinetic (PK) profiles for each arm (Cmax)
Measured: Day 1 - Day 100
Secondary outcomes (6)
Tmax
Time to reach maximum observed serum concentration (Cmax)
Measured: Day 1 - Day 100
t1/2
Apparent terminal elimination half-life (t1/2)
Measured: Day 1 - Day 100
Vz
Apparent volume of distribution (Vz)
Measured: Day 1- Day 100
CL
Apparent total serum clearance ((CL)
Measured: Day 1- Day 100
Safety and Tolerability
Treatment-related Adverse Events
Measured: Day 1- Day 100
Immunogenicity
Assessment of anti-drug antibodies (ADA) against palivizumab
Measured: Day 1- Day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start15 Jun 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
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.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- mAbxience Research S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121246
- Sponsor's protocol ID
- MB05-A-01-21
- Acronym
- FANTASY
- Status last verified
- Sep 2023
- First submitted
- 4 Nov 2021
- Last updated
- 2 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, 3-arm Parallel Study to Compare PK, Safety, IMM and Tolerability of MB05, EU-sourced Synagis® and US-sourced Synagis®, as a Single Dose Intramuscular Injection in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT05121246
- Acronym / sponsor ID
- FANTASY / MB05-A-01-21
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- mAbxience Research S.L.Industry (pharma, biotech, devices)
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Posted 2 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
MB05 is being developed as a potential biosimilar to Synagis® for all indications for which Synagis® is approved. This study is designed to demonstrate PK similarity of the proposed biosimilar test product MB05 and the reference products EU- and US-Synagis®.This is a first-in-human study of the Synagis® biosimilar MB05. The reference product ynagis® was first approved by the US Food and Drug Administration (FDA) in 1998 and by the European Medicines agency (EMA) in 1999.
As a proposed biosimilar, the clinical experience with Synagis® (as described in the Synagis® summary of product characteristics) (most recent versions) is deemed applicable to MB05.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MB05 (Proposed palivizumab biosimilar) | Experimental | Drug: MB05 (Proposed palivizumab biosimilar)Sterile vial 100mg/1ml, single-dose 3mg/kg administered as intramuscular injection on day 1. |
| EU-Synagis® | Active comparator | Drug: EU-Synagis®Sterile vial 100mg/1ml, single-dose 3mg/kg administered as intramuscular injection on day 1 |
| US-Synagis® | Active comparator | Drug: US-Synagis®Sterile vial 100mg/1ml, single-dose 3mg/kg administered as intramuscular injection on day 1 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (34 listed)
- 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:
Key exclusion criteria (26 listed)
- 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.
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 |
|---|---|---|
| MB05 (Proposed palivizumab biosimilar)Single IM dose of 3 mg/kg | Drug | MB05 (Proposed palivizumab biosimilar) |
| EU-Synagis®Single IM dose of 3 mg/kg | Drug | EU-Synagis® |
| US-Synagis®Single IM dose of 3 mg/kg | Drug | US-Synagis® |
Primary outcome
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)
Time frame: Day 1 - Day 100
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).
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.
Time frame: Day 1 - Day 100
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).
Pharmacokinetics (PK)- (AUC0-inf)
Time frame: Day 1 - Day 100
Pharmacokinetic (PK) profiles for each arm (AUC0-inf)
Pharmacokinetics (PK) - (Cmax)
Time frame: Day 1 - Day 100
Pharmacokinetic (PK) profiles for each arm (Cmax)
6 secondary outcomes
Tmax
Time frame: Day 1 - Day 100
t1/2
Time frame: Day 1 - Day 100
Vz
Time frame: Day 1- Day 100
CL
Time frame: Day 1- Day 100
Safety and Tolerability
Time frame: Day 1- Day 100
Immunogenicity
Time frame: Day 1- Day 100
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MB05 (Proposed palivizumab biosimilar), EU-Synagis® and US-Synagis® in people with Healthy Volunteers, run by mAbxience Research S.L. at 3 sites in 2 countries.
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 34 inclusion and 26 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 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in New Zealand, Australia. 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 2 Apr 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?
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) (time frame: Day 1 - Day 100). The study lists 4 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 2 Apr 2025.