A Phase 1 Study of Single and Multiple Intravenous Doses of SM17 in Healthy Subjects (NCT05332834) | Clinical Trial Compass
CompletedPhase 1
A Phase 1 Study of Single and Multiple Intravenous Doses of SM17 in Healthy Subjects
United States77 participantsStarted 2022-06-14
Plain-language summary
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.
Who can participate
Age range19 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Healthy, adult, male or female\* (of non childbearing potential only), 19-55 years of age, inclusive, at the time of consent.
✓. 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
✕. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
✕. History or evidence of a clinically significant disorder (including psychiatric), condition or disease that, in the opinion of the PI or designee would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
✕. History or current medical conditions, such as myocardial infarction or stroke within the 3 months prior to the screening visit, known cardiac disease, uncontrolled hypertension, and aortic or cerebral aneurysm.
What they're measuring
1
Part A and Part B: Number of subjects with adverse events
Timeframe: Until Follow-up (FU) Visit/Early Termination (ET) Visit (14 and 28 days post-last dose)
✕. Previously hospitalized for severe acute respiratory syndrome-coronavirus 2 (SARS Cov 2) prior to the screening visit.
✕. Positive polymerase chain reaction test for SARS-CoV-2, either with the absence or presence of the clinical symptoms of COVID 19
✕. Has evidence of any active or suspected bacterial, viral, fungal, or parasitic infections within the past 6 weeks prior to the screening visit (e.g., common cold, viral syndrome, flu-like symptoms). Subject who, in the opinion of the PI or designee, has a high risk of parasitic disease is also excluded.
✕. Has known Type I/II diabetes.
✕. Was vaccinated with live (attenuated) vaccinations within 1 month prior to the first dosing.