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

Phase 1

Not yet recruiting

• Conditions: Skin Aging
• Interventions: Biological: SPOT-mRNA01; Other: Placebo

• Registration Number: NCT06567119
• Lead Sponsor: SIPO Biotechnology Co. Ltd.

Brief 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.

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.

Study Timeline

• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-22
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-15
• Study Start: 2025-11-12
• Primary Completion: 2027-11-12
• Study Completion: 2027-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPOT-mRNA01	SPOT-mRNA01	SPOT-mRNA01 (COL1A1 mRNA-loaded by EVs)
Placebo	Placebo	Sterile isotonic solution

Primary Outcome Measures

Name	Time	Method
Assessment of the frequency and severity of AEs caused by SPOT-mRNA01	3 months	The investigator will collect a description of the events, time of onset and resolution, assessment of severity and causal relationship to SPOT-mRNA01.

Secondary Outcome Measures

Name	Time	Method
level of COL1A1 protein expression in local dermal tissue after subcutaneous injection of SPOT-mRNA01	Days 4, 7 and 31	Local collagen expression in injection area biopsy by ELISA detection
Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01	Baseline and days 7， 15， 31， 61 and 91	Detecting local skin thickness by Skin ultrasound.