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NOT YET RECRUITING
NCT06567119
PHASE1

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

Sponsor: SIPO Biotechnology Co. Ltd.

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-blind, Placebo-controlled Exploratory Clinical Study to Evaluate the Safety and Tolerability of SPOT-mRNA01 Injection in Healthy Adult Subjects.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-11-12

Completion Date

2027-12-15

Last Updated

2025-05-15

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

SPOT-mRNA01

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

OTHER

Placebo

Sterile isotonic solution, subcutaneous injection