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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-12

Study Completion Date

2027-12-15

Brief Summary

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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.

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Detailed Description

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SPOT-mRNA01 (collagen 1 alpha 1 (COL1A1) mRNA-loaded by Extracellular vesicles （EVs）) can induce collagen protein grafts in dermal tissue, thereby supplementing collagen and reducing wrinkle formation in collagen-depleted skin. Therefore, SPOTmRNA01 can provide a source of human collagen intradermally for cosmetic anti-aging use.

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

Biopsies will be used to detect the expression of collagen in the skin of the injection area.

Conditions

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Skin Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SPOT-mRNA01

SPOT-mRNA01 (COL1A1 mRNA-loaded by EVs)

Group Type ACTIVE_COMPARATOR

SPOT-mRNA01

Intervention Type BIOLOGICAL

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

Placebo

Sterile isotonic solution

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Sterile isotonic solution, subcutaneous injection

Interventions

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SPOT-mRNA01

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

Intervention Type BIOLOGICAL

Placebo

Sterile isotonic solution, subcutaneous injection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Aged 18 to 75 years inclusive at the time of informed consent.

Exclusion Criteria

1. Any transient or chronic skin condition, disorder, or infection within 20 cm of the target areas before treatment that, in the opinion of the investigator, may confound study results.
2. History of laser treatment or chemical peels or any cosmetic anti-aging treatments to the target areas within six months of the study treatment.
3. History of surgical procedures to target areas, including removal of benign or malignant skin cancers that, in the opinion of the investigator, may confound study results.
4. Participant with a history of heavy smoking, alcohol or drug abuse or steroid treatment.
5. Pregnant or breast-feeding females.
6. History of anaphylaxis or allergic reactions to any constituent of the study product and/or local anesthetics, and/or history of severe abnormal drug reaction.
7. Those who have participated in clinical trials of other investigational drugs within 3 months before the study treatment.
8. Those who are not suitable for subcutaneous injection and biopsy.
9. Any condition that the investigator or primary physician believes may not be appropriate for participating the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes