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This trial is a phase 1, first-in-human, randomized, double-blind, placebo-controlled dose escalation trial following single and multiple doses intravenous administration of SM17.
It aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect and immunogenicity of single and multiple doses of SM17 injection in healthy subjects.
Enrollment
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Inclusion criteria
Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study:
Healthy, adult, male or female* (of non childbearing potential only), 19-55 years of age, inclusive, at the time of consent.
* Females of non-childbearing potential are defined as follows:
Females who have undergone one of the following sterilization procedures at least 6 months prior to the first dosing:
Females who are postmenopausal with amenorrhea for at least 1 year prior to the first dosing and follicle stimulating hormone (FSH) serum levels consistent with postmenopausal status at the screening visit.
Male subjects must follow protocol specified contraception guidance as described in Section 12.4.5.
Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
Is a non-smoker or ex-smoker who has stopped smoking for at least 6 months prior to the screening visit. Ex-smokers will have a history of <10 cigarettes pack-year.
Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs (12-lead reporting RR, PR, QRS, QT and QTcF), as deemed by the PI or designee, at the screening visit and prior to the first dosing, including the following:
Must sign an IRB-approved informed consent form (ICF) prior to any study-specific procedures.
Is able to comply with clinic visits and study-related procedures.
Exclusion criteria
Subjects must not be enrolled in the study if they meet any of the following criteria:
Primary purpose
Allocation
Interventional model
Masking
77 participants in 2 patient groups, including a placebo group
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Central trial contact
Angie Badgett, MBA
Data sourced from clinicaltrials.gov
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