A Clinical Study to Evaluate SM17 in Healthy Participants (NCT07466940) | Clinical Trial Compass
CompletedPhase 1
A Clinical Study to Evaluate SM17 in Healthy Participants
China30 participantsStarted 2025-10-14
Plain-language summary
This is a phase I study in Chinese healthy adult volunteer participants. It aims to evaluate the safety, tolerability, PK profile and immunogenicity of a single dose of SM17 SC in healthy Chinese adult participants. It also aims to evaluate the bioavailability of SM17 SC compared to SM17 IV.
Who can participate
Age range18 Years ā 55 Years
SexALL
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Inclusion criteria
ā. Be willing to sign the ICF, and be able to complete clinical visits and study-related procedures.
ā. Aged 18-55 years (both inclusive) at the time of signing the ICF, regardless of sex.
ā. Body mass index (BMI) ā„ 18.5 and \< 28.0 kg/m2, and body weight ā„ 50 kg (for males) and ā„ 45 kg (for females) at screening.
ā. Normal or abnormal but clinically insignificant findings in medical history and inquiries, vital signs, physical examination, laboratory tests (hematology, clinical chemistry, urinalysis, and coagulation tests), immunoglobulins, 12-lead ECG, and non-contrast chest CT at screening.
ā. Fertile men and women of childbearing potential must consent to use one of the highly effective contraceptive methods specified in Appendix 1 of the protocol from signing the ICF to 6 months after dosing, and have no plan to donate sperm or egg cells during this period.
Exclusion criteria
ā. Frequent alcohol consumption within 6 months prior to the screening visit, defined as an average weekly intake of \> 14 units of alcohol (1 unit of alcohol ā 360 mL of beer, 45 mL of spirit with the alcohol content of 40%, or 150 mL of wine), inability to abstain from alcohol from the screening visit or within 48 h pre-dose until the end of study (EOS), or a positive breath alcohol test at baseline.
ā. Current or history of clinically significant diseases deemed by the investigator to be clinically significant or likely to interfere with the study, including but not limited to diseases related to the neurological, cardiovascular, respiratory, hematological, endocrine, genitourinary, gastrointestinal, musculoskeletal systems, etc.
. Planned major surgery during the study, major surgery within 4 weeks prior to dosing, or surgical history deemed clinically significant by the investigator.
ā. Smoking history (\> 5 cigarettes per day on average) within 3 months prior to the screening visit, or inability to abstain from any tobacco products during the study.
ā. PR interval \> 210 ms on 12-lead ECG or QT interval corrected for heart rate using Fridericia's formula (QTcF; see Appendix 3): QTcF ā„ 450 ms for males and QTcF ā„ 470 ms for females.
ā. Abnormal laboratory parameter values as follows: a) total bilirubin \> 1.5 Ć upper limit of normal (ULN); b) alanine aminotransferase or aspartate aminotransferase \> 1.5 Ć ULN; c) serum creatinine \> ULN; d) white blood cell count below the lower limit of normal (LLN); or other abnormalities deemed by the investigator to be clinically significant, rendering the participant ineligible for enrollment.
ā. Recent infections (including chronic or localized infections) within 7 days prior to the screening visit, or presence of recurrent infections that, as assessed by the investigator, may affect the interpretation of trial results.
ā. Received a vaccine within 1 month prior to dosing.