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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Aging
• Intervention / Treatment: Biological: SPOT-mRNA01; Other: Placebo

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Sterile isotonic solution	Other: Placebo; Sterile isotonic solution, subcutaneous injection
Active Comparator: SPOT-mRNA01; SPOT-mRNA01 (COL1A1 mRNA-loaded by EVs)	Biological: SPOT-mRNA01; SPOT-mRNA01 (COL1A1 mRNA-loaded by EVs) ,single-dose subcutaneous injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: SIPO Biotechnology Co. Ltd.
• Collaborators: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Estimated): January 11, 2027
• Primary Completion (Estimated): January 12, 2029
• Study Completion (Estimated): February 12, 2029

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 19, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: SPOT-mRNA01; EVs; COL1A1 mRNA
• Other Study ID Numbers: FM-T1-SH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No