## Protocol Section
### Identification Module
**NCT ID:** NCT06438341

**Brief Title:** Preliminary Evaluation of the Safety and Tolerability of SPOT-mRNA01 Subcutaneously Administered in Healthy Subjects

**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

#### Organization Study ID Info
**ID:** FM-T1-SH
#### Organization
**Class:** INDUSTRY
**Full Name:** Spot Biosystems Ltd.
### Status Module
#### Completion Date
**Date:** 2025-12-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-30

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-09-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-15

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-30
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Spot Biosystems Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 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.

### Conditions Module

**Conditions:**

- Skin Aging

**Keywords:**

- SPOT-mRNA01

- EVs

- COL1A1 mRNA

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** SPOT-mRNA01 (COL1A1 mRNA-loaded EVs)

**Intervention Names:**

- Biological: SPOT-mRNA01

**Label:** SPOT-mRNA01

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Sterile isotonic solution

**Intervention Names:**

- Other: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- SPOT-mRNA01

**Description:** SPOT-mRNA01 (COL1A1 mRNA-loaded EVs) ,single-dose subcutaneous injection

**Name:** SPOT-mRNA01

**Type:** BIOLOGICAL

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Sterile isotonic solution

**Name:** Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** The investigator will collect a description of the events, time of onset and resolution, assessment of severity and causal relationship to SPOT-mRNA01.

**Measure:** Assessment of the safety and tolerability of SPOT-mRNA01 by recording adverse events

**Time Frame:** 3 months

#### Secondary Outcomes

**Description:** Local collagen expression in injection area biopsy by ELISA detection

**Measure:** Assessment of changes in collagen expression level after subcutaneous injection of SPOT-mRNA01

**Time Frame:** Days 4, 7 and 31

**Description:** Detecting local skin thickness in injection area biopsy by Masson trichrome stain

**Measure:** Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01

**Time Frame:** Days 4, 7 and 31

**Description:** Detecting local skin thickness by Skin ultrasound

**Measure:** Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01

**Time Frame:** Baseline and days 7, 15, 31, 61 and 91

### Eligibility Module

**Eligibility Criteria:** 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.

   -

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

## Document Section

### Large Document Module

#### Large Docs

- Date: 2023-08-14

- Filename: Prot_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 687192

- Type Abbrev: Prot

- Upload Date: 2024-05-24T07:36

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M8219

- Name: Exanthema

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
