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 range

18 Years – 55 Years

Sex

ALL

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

. Be willing to sign the ICF, and be able to complete clinical visits and study-related procedures.
. Aged 18-55 years (both inclusive) at the time of signing the ICF, regardless of sex.
. Body mass index (BMI) ≥ 18.5 and \< 28.0 kg/m2, and body weight ≥ 50 kg (for males) and ≥ 45 kg (for females) at screening.
. 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.
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of treatment emergent AEs

Timeframe: Day 0 to Day 85

Trial details

NCT IDNCT07466940

SponsorSinoMab BioScience Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-03

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