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

NCT06567119 | Not Yet Recruiting Phase 1

• 1 other identifier: FM-T1-SH
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Skin Aging

Keywords

SPOT-mRNA01; COL1A1 mRNA; EVs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• level of COL1A1 protein expression in local dermal tissue after subcutaneous injection of SPOT-mRNA01

  Days 4, 7 and 31

• Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01

  Days 4, 7 and 31

• Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01

  Baseline and days 7， 15， 31， 61 and 91

Study Arms (2)

SPOT-mRNA01

ACTIVE COMPARATOR

SPOT-mRNA01 (COL1A1 mRNA-loaded by EVs)

Biological: SPOT-mRNA01

Placebo

PLACEBO COMPARATOR

Sterile isotonic solution

Other: Placebo

Interventions

SPOT-mRNA01 BIOLOGICAL

SPOT-mRNA01 (COL1A1 mRNA-loaded by EVs) ,single-dose subcutaneous injection

SPOT-mRNA01

Placebo OTHER

Sterile isotonic solution, subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75 years inclusive at the time of informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 22, 2024
• Study Start (Estimated): January 11, 2027
• Primary Completion (Estimated): January 12, 2029
• Study Completion (Estimated): February 12, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04