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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 until follow-up (fu) visit/early termination (et) visit (14 and 28 days post-last dose)
Awards & highlights
Summary
This trial tests a new drug called SM17 given through an IV in healthy people. It aims to see if SM17 is safe and how the body processes it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until follow-up (fu) visit/early termination (et) visit (14 and 28 days post-last dose)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until follow-up (fu) visit/early termination (et) visit (14 and 28 days post-last dose)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part A and Part B: Number of subjects with adverse events
Other study objectives
Pharmacokinetic parameters of SM17 in healthy subjects
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Drug SM17Experimental Treatment1 Intervention
Peripheral intravenous injection
Group II: Drug PlaceboPlacebo Group1 Intervention
Peripheral intravenous injection
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
SinoMab BioScience LtdLead Sponsor
4 Previous Clinical Trials
754 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You received any live vaccines within the month before starting the study.You have had any kind of infection, like a cold or the flu, in the past 6 weeks. You may also be excluded if the doctor thinks you have a high risk of getting a parasite infection.You have a history of alcohol or drug abuse within the past 2 years.You have had a bad reaction to protein treatments, medications, or any ingredients in SM17 or similar compounds in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Drug Placebo
- Group 2: Drug SM17
Awards:
This trial has 0 awards, including: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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