Your session is about to expire
← Back to Search
Protein Replacement Therapy
BMN 111 injection with injector pen for Achondroplasia
Phase 1
Waitlist Available
Research Sponsored by BioMarin Pharmaceutical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose, 2, 5, 15, 30, 45, 60, and 75 minutes and 1.5, 2, 2.5, 3, 4, 6, and 8 hours postdose
Awards & highlights
Study Summary
This trial looks at if a single dose of medicine is the same when injected using two different devices.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose, 2, 5, 15, 30, 45, 60, and 75 minutes and 1.5, 2, 2.5, 3, 4, 6, and 8 hours postdose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose, 2, 5, 15, 30, 45, 60, and 75 minutes and 1.5, 2, 2.5, 3, 4, 6, and 8 hours postdose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Area under the concentration versus time curve from time 0 to infinity (AUC0-∞)
Area under the concentration versus time curve from time 0 to t, where t is the last timepoint with a measurable concentration (AUC0-t)
Maximum observed drug concentration (Cmax)
Secondary outcome measures
Incidence and severity of adverse events
Time of Cmax (tmax)
Time of t1/2
+1 moreSide effects data
From 2019 Phase 3 trial • 121 Patients • NCT0319776673%
Injection site reaction
68%
Injection site erythema
38%
Injection site swelling
27%
Vomiting
27%
Nasopharyngitis
23%
Headache
17%
Pyrexia
15%
Arthralgia
13%
Injection site urticaria
13%
Upper respiratory tract infection
12%
Blood pressure decreased
12%
Cough
10%
Ear pain
10%
Oropharyngeal pain
10%
Otitis media
10%
Diarrhoea
10%
Ear infection
8%
Pain in extremity
8%
Viral infection
8%
Injection site bruising
8%
Influenza
7%
Fatigue
7%
Gastroenteritis
7%
Gastroenteritis viral
7%
Injection site mass
7%
Seasonal allergy
7%
Dizziness
7%
Fall
5%
Arthropod bite
5%
Nausea
5%
Tonsillitis
5%
Injection site rash
5%
Otorrhoea
5%
Abdominal pain
5%
Nasal congestion
5%
Dry skin
5%
Vitamin D deficiency
3%
Ligament sprain
3%
Procedural anxiety
3%
Neck pain
3%
Bone contusion
3%
Injection site induration
3%
Body temperature increased
3%
Injection site vesicles
3%
Bronchitis
3%
Otitis externa
3%
Injection site pain
3%
Injection site haemorrhage
3%
Enterobiasis
3%
Injection site inflammation
3%
Abdominal pain upper
3%
Paraesthesia
3%
Presyncope
3%
Rhinorrhoea
3%
Tympanic membrane perforation
2%
Pallor
2%
Nasal obstruction
2%
Skin abrasion
2%
Localised infection
2%
Streptococcal infection
2%
Arthropod sting
2%
Thermal burn
2%
Drug eruption
2%
Back injury
2%
Procedural dizziness
2%
Viral pharyngitis
2%
Gingival pain
2%
Pharyngitis
2%
Dermatitis allergic
2%
Rash pruritic
2%
Hyperhidrosis
2%
Adenoidal hypertrophy
2%
Impetigo
2%
Migraine
2%
Otitis media acute
2%
Viral upper respiratory tract infection
2%
Scarlet fever
2%
Tooth abscess
2%
Pruritus
2%
Enuresis
2%
Cellulitis
2%
Influenza like illness
2%
Lower respiratory tract infection
2%
Back pain
2%
Contusion
2%
Sleep apnoea syndrome
2%
Ocular hyperaemia
2%
Arthropathy
2%
Sinusitis
2%
Radius fracture
2%
Varicella
2%
Constipation
2%
Pulmonary congestion
2%
Gait disturbance
2%
Lethargy
2%
Injection site discolouration
2%
Injection site pruritus
2%
Croup infectious
2%
Hand-foot-and-mouth disease
2%
Disturbance in attention
2%
Hyperreflexia
2%
Hypotension
2%
Scratch
2%
Ear discomfort
2%
Excessive cerumen production
2%
External ear inflammation
2%
Middle ear effusion
2%
Acanthosis nigricans
2%
Acne
2%
Rash
2%
Malaise
2%
Pain
2%
Lip swelling
2%
Malpositioned teeth
2%
Device expulsion
2%
Vulvovaginal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
BMN 111 - 15 μg/kg
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: BMN 111 injection with injector penExperimental Treatment1 Intervention
Study treatment will be provided in a prefilled injector pen containing a dual chamber drug cartridge, for reconstitution and injection, after setting of the specified dose with the 2.0 mg/mL formulation.
Group II: BMN 111 injection with vial and syringeActive Control1 Intervention
Study treatment will be provided in glass vials. Each glass vial will be labeled as required per country requirement. Pre-filled Diluent Transfer Syringes will be provided for reconstitution.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
BioMarin PharmaceuticalLead Sponsor
156 Previous Clinical Trials
190,689 Total Patients Enrolled
13 Trials studying Achondroplasia
3,079 Patients Enrolled for Achondroplasia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Non-smokers of any ethnic background, who have either never smoked or quit more than three months ago, are eligible to participate.You must have no clinically significant abnormalities as per a medical assessment, which includes past medical history, physical examination and tests, cardiac monitoring, temperature check and evaluation of current medications.All participants must be non-pregnant, non-lactating females and all other genders should use contraception.This clinical study is open to both male and female participants.You weigh between 60 and 110 kg, with a body mass index of 18.0 to 32.0 kg/m2.Male and female participants must abide by local regulations regarding contraceptive methods when participating in clinical studies.You have a skin condition or tattoos that could prevent you from receiving the study drug.You are between 18 and 55 years of age at the time you signed your informed consent.In order to participate, you must be able to provide a signed and informed consent that adheres to the requirements and restrictions specified in the Informed Consent Form (ICF).You have a history of migraines.You have participated in a clinical trial involving a new, experimental drug within the last 30 days or five times the amount of time it takes for the drug to leave your body (whichever is longer).You have a significant medical history or symptoms of any health condition, as determined by the person in charge of the study.You have a history of severe allergic reactions or intolerance to any medication, food or substance, unless the study doctor has approved it.You are currently using medications that are not allowed in the study.You cannot take any medication or products that might change how the study drug is processed by your body, like St. John's wort, for at least 30 days before starting the study unless the investigator says it is okay.
Research Study Groups:
This trial has the following groups:- Group 1: BMN 111 injection with vial and syringe
- Group 2: BMN 111 injection with injector pen
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment accommodating individuals of advanced age?
"This research project is recruiting patients who are of legal age or above, and less than 55 years old."
Answered by AI
Is the enrollment period for this research still available?
"As reported by clinicaltrials.gov, this trial is actively seeking qualified applicants since its initial posting on March 15th 2023 and latest update on April 2nd 2023."
Answered by AI
What demographic is this clinical trial specifically targeting?
"Applicants to this medical trial must suffer from achondroplasia and be between 18-55 years old. A total of 72 people are needed for the study."
Answered by AI
What adverse effects have been documented with BMN 111 administered via an injector pen?
"Our team at Power has assessed the safety of BMN 111 injection with injector pen to be a 1 due to its status as a Phase 1 trial, indicating limited evidence supporting both efficacy and safety."
Answered by AI
What is the capacity of enrollees in this research program?
"Affirmative, clinicaltrials.gov states that this trial is currently enrolling people for the study. The posting date was March 15th 2023 and it has since been updated on April 2nd of the same year. 72 participants from one site are needed to complete this research project."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger