Hypertrophic ScarPhase 1/2NCT05196373
Safety, Tolerability, Pharmacokinetics, Immunogenicity and Efficacy of STP705 in Adult Patients With Hypertrophic Scars
A Phase 1/2 study testing STP705 in people with Hypertrophic Scar, run by Sirnaomics at 1 site in China.
Trial summary
Adult patients with hypertrophic scars 30 Subjects in Dose Escalation 20 Subjects in Dose Expansion Intrascar injection of STP705 weekly for 4 weeks Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Hypertrophic Scar
- What is being tested?
- STP705
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 7 Dec 2021to 30 Jun 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female adult ≥ 18 and ≤ 45 years old at the time of signing the ICF,
- Diagnosed with hypertrophic scars, with all the following characteristics:
- Linear hypertrophic scar, with a width of 0.3-1.0 cm and a length of ≥10 cm;
- Scars with any of the following characteristics: redness or purpleness, stiffness, rough surface, significant swelling, visible dilated capillaries on the surface, and possibly accompanied by pain or itching;
- The course of the disease is 6 to 24 months (inclusive);
- Scars are not located on the face, front of the neck, feet, hands, knees, elbows or any joints;
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- The examination during the screening period must meet the following criteria: medical history, physical examination (excluding hypertrophic scar), 12-lead ECG, vital signs, laboratory examinations are judged by the investigator to meet the requirements, and no clinically significant abnormalities were observed;
- Subjects of childbearing potential (male or female) must take effective medical contraceptive measures during the study and within 6 months after the end of administration;
- Subjects voluntarily participate in this clinical trial and sign the ICF, can understand and comply with the study procedures, and complete the entire study as specified by the protocol.
Who cannot join
- Diagnosed with keloid or burn scar;
- Positive in hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV), or syphilis antibody tests;
- Medication history of corticosteroids use (including inhaled steroids, triamcinolone acetonide, etc.) and COX-2 inhibitors within 3 months before the first injection of the study (if 5 times the half-life is longer than 3 months, then 5 times the half-life will prevail);
- Impaired immune function (such as cancer, or other diseases that affect the basic immune responses);
- Concomitant diseases that is uncontrolled or poorly controlled or may affect the study, including clinically important cardiovascular, lung, kidney, endocrine, liver, nerve, mental, immune, gastrointestinal, blood, urogenital, skeletal or metabolic disorders at the investigator's discretion;
- Known to be allergic to STP705 or any components of its prescription;
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- Having difficulty in venous blood collection, or having a history of needle fainting or blood fainting;
- Infection or trauma in the site to be treated;
- Pregnant and lactating women;
- Participated in other clinical studies and received treatment within 3 months before the first injection;
- Blood donation or blood loss ≥400 mL within 3 months before the first injection (except for female blood loss during menstrual period), or planning to donate blood or blood components during the study period or within 3 months after the end of the study;
- History of drug abuse/dependence or drug history or positive in drug abuse screening (screening items can include: morphine, tetrahydrocannabinol acid, methamphetamine, methylenedioxy methanphetamine, ketamine and cocaine) within 1 year before the first injection;
- Medication history of any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, etc.) or health care products within 14 days before the first injection;
- Vaccinated with live vaccines within 4 weeks before the first injection or planning to receive live vaccines within 4 weeks after the last dose. Live vaccines include but not limited to: measles, mumps, rubella, chickenpox, yellow fever, rabies, Bacillus Calmette-Guerin, typhoid fever, COVID-19 live vaccines, etc.;
- Any surgical, medical or laboratory pathophysiological conditions that may interfere with the safety, distribution, metabolism or excretion of the investigational drug at the discretion of the investigator;
- Unable to communicate or cooperate with medical staff due to neurological, mental disorders or language/ verbal communication issues;
- Other situations not suitable for participation in the study as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
The 9th Hospital of Shanghai
Shanghai, Shanghai Municipality, 200000
About this study
Official title: A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of STP705 Administered as Intrascar Injection in Adult Patients With Hypertrophic Scars
Adult patients with hypertrophic scars 30 Subjects in Dose Escalation 20 Subjects in Dose Expansion Intrascar injection of STP705 weekly for 4 weeks
Read the detailed description
An open label study design to evaluate the preliminary efficacy of STP705 in adult patients with hypertrophic scars.
The study is divided into 2 stages:
- Dose Escalation: 30 subjects to be enrolled in this stage with a total of 6 dose groups.
3 subjects will be enrolled in 10ug and 20ug groups and 6 subjects in the subsequent groups of 40ug, 60ug, 80u and 100ug.
- Dose Expansion:1-2 dose groups will be selected and 20 subjects will be enrolled in each group.
- Conditions
- Hypertrophic Scar
- Being tested
- STP705
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STP705Drug
STP705 Powder for Injection composed of siRNA-TGF-B1 and siRNA-COX-2 packged in a proprietary polymer nanoparticle formulation for delivery.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Group 1 | Experimental | 10ug Intrascar injection Receives: Drug: STP705 |
| Part 1: Group 2 | Experimental | 20ug Intrascar injection Receives: Drug: STP705 |
| Part 1: Group 3 | Experimental | 40ug Intrascar injection Receives: Drug: STP705 |
| Part 1: Group 4 | Experimental | 60ug Intrascar injection Receives: Drug: STP705 |
| Part 1: Group 5 | Experimental | 80ug Intrascar injection Receives: Drug: STP705 |
| Part 1: Group 6 | Experimental | 100ug Intrascar injection Receives: Drug: STP705 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of siRNA-TGF-B1 and siRNA-COX-2 in serum
siRNA-TGF-B1 and siRNA-COX-2 and HKP will be calculated
Measured: 7 weeks
Secondary outcomes (2)
Change of the scar from baseline using Observer Scar Assessment Scale
The scale will be used to record: vascularity, pigmentation, thickness, releif, pliability, surface area of the scar where 1= Normal skin and 10 = the worst case.
Measured: 7 weeks
Change of the scar from baseline using Patient scale
The scale will be used to record: pain, itching, color, hardness, thickness, and relief where 1= No, not different from normal and 10 = Yes, very different from normal.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start7 Dec 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Why it stopped: Study was cancelled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic ScarStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Open label, Dose Escalation and Dose Expansion
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sirnaomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196373
- Sponsor's protocol ID
- SRN-705-009
- Status last verified
- Jul 2026
- First submitted
- 15 Dec 2021
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of STP705 Administered as Intrascar Injection in Adult Patients With Hypertrophic Scars
- ClinicalTrials.gov ID
- NCT05196373
- Acronym / sponsor ID
- SRN-705-009
- Conditions
- Hypertrophic Scar
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was cancelled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- SirnaomicsIndustry (pharma, biotech, devices)
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 19 Jan 2022 (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.
Adult patients with hypertrophic scars 30 Subjects in Dose Escalation 20 Subjects in Dose Expansion Intrascar injection of STP705 weekly for 4 weeks
Detailed description
An open label study design to evaluate the preliminary efficacy of STP705 in adult patients with hypertrophic scars.
The study is divided into 2 stages:
- Dose Escalation: 30 subjects to be enrolled in this stage with a total of 6 dose groups.
3 subjects will be enrolled in 10ug and 20ug groups and 6 subjects in the subsequent groups of 40ug, 60ug, 80u and 100ug.
- Dose Expansion:1-2 dose groups will be selected and 20 subjects will be enrolled in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- Open label, Dose Escalation and Dose Expansion
| Arm | Type | Receives |
|---|---|---|
| Part 1: Group 1 | Experimental | Drug: STP70510ug Intrascar injection |
| Part 1: Group 2 | Experimental | Drug: STP70520ug Intrascar injection |
| Part 1: Group 3 | Experimental | Drug: STP70540ug Intrascar injection |
| Part 1: Group 4 | Experimental | Drug: STP70560ug Intrascar injection |
| Part 1: Group 5 | Experimental | Drug: STP70580ug Intrascar injection |
| Part 1: Group 6 | Experimental | Drug: STP705100ug Intrascar injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female adult ≥ 18 and ≤ 45 years old at the time of signing the ICF,
- Diagnosed with hypertrophic scars, with all the following characteristics:
- The examination during the screening period must meet the following criteria: medical history, physical examination (excluding hypertrophic scar), 12-lead ECG, vital signs, laboratory examinations are judged by the investigator to meet the requirements, and no clinically significant abnormalities were observed;
- Subjects of childbearing potential (male or female) must take effective medical contraceptive measures during the study and within 6 months after the end of administration;
- Subjects voluntarily participate in this clinical trial and sign the ICF, can understand and comply with the study procedures, and complete the entire study as specified by the protocol.
Key exclusion criteria (17 listed)
- Diagnosed with keloid or burn scar;
- Positive in hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV), or syphilis antibody tests;
- Medication history of corticosteroids use (including inhaled steroids, triamcinolone acetonide, etc.) and COX-2 inhibitors within 3 months before the first injection of the study (if 5 times the half-life is longer than 3 months, then 5 times the half-life will prevail);
- Impaired immune function (such as cancer, or other diseases that affect the basic immune responses);
- Concomitant diseases that is uncontrolled or poorly controlled or may affect the study, including clinically important cardiovascular, lung, kidney, endocrine, liver, nerve, mental, immune, gastrointestinal, blood, urogenital, skeletal or metabolic disorders at the investigator's discretion;
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 |
|---|---|---|
| STP705STP705 Powder for Injection composed of siRNA-TGF-B1 and siRNA-COX-2 packged in a proprietary polymer nanoparticle formulation for delivery. | Drug | Part 1: Group 1, Part 1: Group 2, Part 1: Group 3, Part 1: Group 4, Part 1: Group 5, Part 1: Group 6 |
Primary outcome
Concentration of siRNA-TGF-B1 and siRNA-COX-2 in serum
Time frame: 7 weeks
siRNA-TGF-B1 and siRNA-COX-2 and HKP will be calculated
2 secondary outcomes
Change of the scar from baseline using Observer Scar Assessment Scale
Time frame: 7 weeks
Change of the scar from baseline using Patient scale
Time frame: 7 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing STP705 in people with Hypertrophic Scar, run by Sirnaomics at 1 site in China.
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 9 inclusion and 17 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: withdrawn, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Concentration of siRNA-TGF-B1 and siRNA-COX-2 in serum (time frame: 7 weeks). 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 29 Jul 2026.