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

SIPO Biotechnology Co. Ltd.

Status and phase

Not yet enrolling

Phase 1

Conditions

Skin Aging

Treatments

Biological: SPOT-mRNA01

Other: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06567119

FM-T1-SH

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.