Skin AgingPhase 1NCT06567119
Preliminary Evaluation of the Safety and Tolerability of SPOT-mRNA01 Subcutaneously Administered in Healthy Subjects
A Phase 1 study testing SPOT-mRNA01 in people with Skin Aging, run by SIPO Biotechnology Co. Ltd..
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- SPOT-mRNA01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 11 Jan 2027to 12 Feb 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years inclusive at the time of informed consent.
Who cannot join
- 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.
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- 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.
About this study
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.
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.
Read the 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.
- Conditions
- Skin Aging
- Being tested
- SPOT-mRNA01, Placebo
- Keywords
- SPOT-mRNA01, COL1A1 mRNA, EVs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPOT-mRNA01Biological
SPOT-mRNA01 (COL1A1 mRNA-loaded by EVs) ,single-dose subcutaneous injection
PlaceboOther
Sterile isotonic solution, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| SPOT-mRNA01 | Active comparator | SPOT-mRNA01 (COL1A1 mRNA-loaded by EVs) Receives: Biological: SPOT-mRNA01 |
| Placebo | Placebo comparator | Sterile isotonic solution Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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
Measured: Days 4, 7 and 31
Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01
Detecting local skin thickness in injection site biopsy by Masson trichrome stain.
Measured: Days 4, 7 and 31
Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01
Detecting local skin thickness by Skin ultrasound.
Measured: Baseline and days 7， 15， 31， 61 and 91
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start11 Jan 2027 (estimated)
- Primary completion12 Jan 2029 (estimated)
- Study completion12 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SIPO Biotechnology Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567119
- Sponsor's protocol ID
- FM-T1-SH
- Status last verified
- Apr 2026
- First submitted
- 14 Aug 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06567119
- Acronym / sponsor ID
- FM-T1-SH
- Conditions
- Skin Aging
- Keywords
- SPOT-mRNA01, COL1A1 mRNA, EVs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- SIPO Biotechnology Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Study start
- 11 Jan 2027 (estimated)
- Primary completion
- 12 Jan 2029 (estimated)
- Study completion
- 12 Feb 2029 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPOT-mRNA01 | Active comparator | Biological: SPOT-mRNA01SPOT-mRNA01 (COL1A1 mRNA-loaded by EVs) |
| Placebo | Placebo comparator | Other: PlaceboSterile isotonic solution |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18 to 75 years inclusive at the time of informed consent.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPOT-mRNA01SPOT-mRNA01 (COL1A1 mRNA-loaded by EVs) ,single-dose subcutaneous injection | Biological | SPOT-mRNA01 |
| PlaceboSterile isotonic solution, subcutaneous injection | Other | Placebo |
Primary outcome
Assessment of the frequency and severity of AEs caused by SPOT-mRNA01
Time frame: 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.
3 secondary outcomes
level of COL1A1 protein expression in local dermal tissue after subcutaneous injection of SPOT-mRNA01
Time frame: Days 4, 7 and 31
Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01
Time frame: Days 4, 7 and 31
Assessment of skin thickness after subcutaneous injection of SPOT-mRNA01
Time frame: Baseline and days 7， 15， 31， 61 and 91
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SPOT-mRNA01 in people with Skin Aging, run by SIPO Biotechnology Co. Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the frequency and severity of AEs caused by SPOT-mRNA01 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.