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Not yet recruiting NCT06567119

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

Phase I Interventional Skin Aging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SPOT-mRNA01, Placebo.
Who it may be relevant to
Registry conditions: Skin Aging. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Detailed description

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.

Interventions

  • Biological SPOT-mRNA01
    SPOT-mRNA01 (COL1A1 mRNA-loaded by EVs) ,single-dose subcutaneous injection
  • Other Placebo
    Sterile isotonic solution, subcutaneous injection

Primary outcome measures

  • Assessment of the frequency and severity of AEs caused by SPOT-mRNA01 [Time frame: 3 months]
Secondary outcome measures (3)
  • level of COL1A1 protein expression in local dermal tissue after subcutaneous injection of SPOT-mRNA01 [Time frame: Days 4, 7 and 31]
  • Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01 [Time frame: Days 4, 7 and 31]
  • Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01 [Time frame: Baseline and days 7， 15， 31， 61 and 91]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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.
  • History of laser treatment or chemical peels or any cosmetic anti-aging treatments to the target areas within six months of the study treatment.
  • 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.
  • Participant with a history of heavy smoking, alcohol or drug abuse or steroid treatment.
  • Pregnant or breast-feeding females.
  • 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.
  • Those who have participated in clinical trials of other investigational drugs within 3 months before the study treatment.
  • Those who are not suitable for subcutaneous injection and biopsy.
  • Any condition that the investigator or primary physician believes may not be appropriate for participating the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06567119 · FM-T1-SH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗