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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 up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is evaluating two ways of administering a medication called BMN 111 to determine if they are equally effective.
Eligible Conditions
- Achondroplasia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
BioMarin PharmaceuticalLead Sponsor
159 Previous Clinical Trials
115,038 Total Patients Enrolled
13 Trials studying Achondroplasia
3,079 Patients Enrolled for Achondroplasia
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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.
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