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A Clinical Study to Evaluate SM17 in Healthy Participants

NCT07466940 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

SM17

SM17 monoclonal antibody

DRUG

SM17 placebo

placebo to be compared with SM17, excipient solution of SM17 monoclonal antibody without protein

Sponsors & Collaborators

  • SinoMab BioScience Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-14
Primary Completion
2026-02-03
Completion
2026-02-03
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07466940 on ClinicalTrials.gov