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A Phase 1 Study of Single and Multiple Intravenous Doses of SM17 in Healthy Subjects

NCT05332834 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2024-09-27

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

SM17

Peripheral intravenous injection

OTHER

Placebo

Peripheral intravenous injection

Sponsors & Collaborators

  • SinoMab BioScience Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2022-06-14
Primary Completion
2023-09-26
Completion
2023-09-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05332834 on ClinicalTrials.gov