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Preliminary Evaluation of the Safety and Tolerability of SPOT-mRNA01 Subcutaneously Administered in Healthy Subjects

NCT06567119 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-23

No results posted yet for this study

Summary

This is a first-in-human, randomized, double-blind, placebo-controlled clinical study to evaluate the Safety and Tolerability of SPOT-mRNA01 injection in healthy adult volunteers.

Conditions

  • Skin Aging

Interventions

BIOLOGICAL

SPOT-mRNA01

SPOT-mRNA01 (COL1A1 mRNA-loaded by EVs) ,single-dose subcutaneous injection

OTHER

Placebo

Sterile isotonic solution, subcutaneous injection

Sponsors & Collaborators

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    collaborator OTHER

  • SIPO Biotechnology Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2027-01-11
Primary Completion
2029-01-12
Completion
2029-02-12

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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 NCT06567119 on ClinicalTrials.gov