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

Skin Aging Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06438341
• Other study ID #: FM-T1-SH
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 15, 2024
• Est. completion date: December 15, 2025

Study information

• Verified date: May 2024
• Source: Spot Biosystems Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

SPOT-mRNA01 (collagen 1 alpha 1 (COL1A1) mRNA-loaded EVs) can induce collagen protein grafts in dermal tissue, thereby supplementing collagen and reducing wrinkle formation in collagen-depleted skin. Therefore, SPOT-mRNA01 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 15, 2025
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

-

Related Conditions & MeSH terms

• Skin Aging

Intervention

Biological:
• SPOT-mRNA01
SPOT-mRNA01 (COL1A1 mRNA-loaded EVs) ,single-dose subcutaneous injection

Other:
• Placebo
Sterile isotonic solution

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Spot Biosystems Ltd.	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the safety and tolerability of SPOT-mRNA01 by recording adverse events	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	Assessment of changes in collagen expression level after subcutaneous injection of SPOT-mRNA01	Local collagen expression in injection area biopsy by ELISA detection	Days 4, 7 and 31
Secondary	Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01	Detecting local skin thickness in injection area biopsy by Masson trichrome stain	Days 4, 7 and 31
Secondary	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