Superficial Skin and Soft Tissue Infections Caused by Gram-positive BacteriaPhase 1NCT07790770

A Phase I Clinical Trial to Evaluate CMS-F021 Following Single and Multiple Doses in Healthy Participants

A Phase 1 study testing CMS-F021 Gel and Drug: CMS-F021 Gel healthy participant in people with Superficial Skin and Soft Tissue Infections Caused by Gram-positive Bacteria, run by Dermavon Holdings Limited at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Superficial Skin and Soft Tissue Infections Caused by Gram-positive Bacteria
What is being tested?: CMS-F021 Gel and Drug: CMS-F021 Gel healthy participant
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 72 participants
Where: 1 siteChina
Study dates: 21 Jul 2026to Mar 2027
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Participants must meet all of the following eligibility criteria to be enrolled in this study:
Voluntarily participate in this study and sign the informed consent form, able to understand and comply with all requirements and restrictions of this study, and capable of completing the study according to the protocol;
Age between 18 and 55 years (inclusive of boundary values, based on the date of signing the informed consent form), male or female;
Body mass index (BMI) within the range of 19.0-26.0 kg/m² (inclusive of boundary values) at screening, with female weight ≥ 45.0 kg and male weight ≥ 50.0 kg;
Participants with reproductive potential (including their partners) must have no plans for pregnancy, egg donation, or sperm donation from the date of signing the informed consent form until 3 months after the last dose of study medication, and must strictly adhere to contraceptive measures during this period.

Who cannot join

Any participant meeting any of the following exclusion criteria will not be eligible for enrollment:
Those with a history of allergy or allergic constitution;
Abnormal vital signs, physical examination, laboratory tests (complete blood count, blood biochemistry, coagulation function, urinalysis), or 12-lead ECG findings at screening, judged by the investigator to have clinical significance;
History or clinical manifestations of significant diseases involving cardiovascular, respiratory, digestive, urinary/reproductive, hematologic, endocrine/metabolic, rheumatologic/immunologic, neurological/psychiatric, or musculoskeletal systems requiring medication and/or other treatments (including dietary restrictions and physical therapy), or considered by the investigator unsuitable for participation in this study; 4）Those with a history of severe skin diseases;
5) Evidence of current acute skin infection, or history of recurrent or chronic severe skin infections; 6) Researchers believe there may be some skin conditions that could interfere with skin assessment; 7) Use of any prescription or non-prescription medication (including herbal medicines, vitamins, minerals, and dietary supplements) within 2 weeks before dosing or within at least five half-lives (whichever is longer); 8) Participation in any other clinical trial involving drugs or medical devices within 3 months prior to screening, or planning to participate in such trials during this study, or still within the 5 half-life window of a previous investigational agent (whichever is longer); 9) History of drug abuse within the past 6 months, or positive results in any drug abuse screening test; 10) Weekly alcohol consumption exceeding 14 units within the past 3 months (1 unit = 360 mL beer, 150 mL wine, or 45 mL spirits), or positive alcohol breath test result, or inability to abstain from alcohol during the study; 11) Average daily smoking of more than 5 cigarettes within the past 3 months, or inability to discontinue use of any tobacco products during the study; 12) Pregnant or breast feeding females; 13) Difficulty with venipuncture (e.g., history of needle phobia or fainting due to blood draw), or poor venous access deemed unsuitable by the investigator; 14) Blood donation or blood loss ≥ 400 mL within 3 months prior to screening, or receipt of blood transfusion or blood products, or plan to donate blood during the study period; 15) Any other condition determined by the investigator to be unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

HAN WU contact

86-0755-82418801

h.wu@cms.net.cn

China1 site, 1 recruiting

Beijing Jishuitan Hospital,Capital Medical University
Beijing
Recruiting

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, PK Characteristics of CMS-F021 Following Single and Multiple Topical Administrations in Healthy Participants

"This study is a first-in-human (FIH) trial of CMS-F021 conducted in healthy Chinese adult participants, consisting of two parts: Part 1-a single ascending dose (SAD) study (referred to as Part 1 SAD), and Part 2-a multiple ascending dose (MAD) study (referred to as Part 2 MAD). The study aims to evaluate the safety, tolerability, pharmacokinetic (PK) characteristics of CMS-F021 gel following single and multiple topical administrations in healthy Chinese adult participants.

Both parts of the study are designed as randomized, double-blind, placebo controlled, sequential cohort trials. Part 1 SAD plans to include 5 dose cohorts,with 8 participants per cohort (6 receiving CMS-F021 and 2 receiving placebo),for a total of 40 participants. Part 2 MAD plans to include 4 dose cohorts, with 8 participants per cohort (6 receiving CMS-F021 and 2 receiving placebo), for a total of 32 participants."

Conditions: Superficial Skin and Soft Tissue Infections Caused by Gram-positive Bacteria
Being tested: CMS-F021 Gel, Drug: CMS-F021 Placebo Gel healthy participant, Drug: CMS-F021 Gel healthy participant, "Drug: CMS-F021 Placebo Gel healthy participant"

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CMS-F021 GelDrug
Single Dose
Drug: CMS-F021 Placebo Gel healthy participantDrug
Single Dose
Drug: CMS-F021 Gel healthy participantDrug
Multiple Dose
"Drug: CMS-F021 Placebo Gel healthy participant"Drug
Multiple Dose

Study groups in NCT07790770
Study group	Role	What they receive
"Experimental: Single Dose Escalation of CMS-F021 5 sequential dose escalation cohorts - participant	Active comparator	"Drug: CMS-F021 Gel healthy participant" Receives: Drug: CMS-F021 Gel
"Experimental: Single Dose Escalation of placebo 5 sequential dose escalation cohorts - par	Placebo comparator	"Drug: CMS-F021 Placebo Gel healthy participant" Receives: Drug: Drug: CMS-F021 Placebo Gel healthy participant
"Experimental: Multiple Dose Escalation of CMS-F021 4 sequential dose escalation cohorts - participa	Active comparator	"Drug: CMS-F021 Gel healthy participant" Receives: Drug: Drug: CMS-F021 Gel healthy participant
"Experimental: Multiple Dose Escalation of placebo 4 sequential dose escalation cohorts - participan	Placebo comparator	"Drug: CMS-F021 Placebo Gel healthy participant" Receives: Drug: "Drug: CMS-F021 Placebo Gel healthy participant"

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline to each visit point in vital signs (temperature, blood pressure, heart rate, respiratory rate)
Measured using electronic sphygmomanometer/thermometer according to standard procedures, record actual values at each visit point, and assess abnormal values.
Measured: through study completion,an average of 4 days or 10 days
Incidence rate of abnormal findings in comprehensive systemic physical examination
Record abnormal physical examination findings by system (cardiovascular, respiratory, digestive, etc.), summarize the number and incidence rate of abnormalities in each system, and categorize them as related or unrelated to the study drug.
Measured: through study completion,an average of 4 days or 10 days
Hematology, biochemistry, urinalysis ，and Coagulation Profilelaboratory test indicators
The tests include complete blood count (WBC, RBC, Hb, etc.), blood biochemistry (ALT, AST, Cr, etc.), urinalysis ，and Coagulation Profile; changes from baseline were calculated, and the incidence of abnormal values was summarized according to CTCAE 6.0 grading.
Measured: through study completion,an average of 4 days or 10days
12-lead electrocardiogram QTc interval, heart rate, and incidence of morphological abnormalities
Collected using standard 12-lead ECG equipment,with the number and incidence rate of QTc interval changes, heart rate abnormalities, and morphological abnormalities summarized.
Measured: through study completion,an average of 4 days or 10days
Skin Irritation Score
Skin reactions will be assessed using the skin irritation scoring scale specified in the FDA and CDE guidance documents, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs and Technical Guidance for Clinical Trials Evaluating Adhesion and Irritation/Sensitization of Transdermal and Topical Delivery Systems for Chemical Generic Drugs (Trial Implementation).
Measured: through study completion,an average of 4 days or 10days

Secondary outcomes (3)

Maximum plasma drug concentration (Cmax)
Calculate the maximum observed plasma concentration from the plasma drug concentration-time curve after administration using non-compartmental analysis (NCA)
Measured: Through 48 hours post-dose
Tmax
Using non-compartmental analysis (NCA) to calculate the time to reach Cmax after drug administration
Measured: Through 48 hours post-dose
Area under the curve (AUC0-t)
Calculate the area under the concentration-time curve from time of administration (0 h) to the last quantifiable concentration time point (t) using non-compartmental analysis (NCA)
Measured: Through 48 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jul 2026Mar 2027

First posted27 Aug 2026
Study start21 Jul 2026
Primary completionJan 2027 (estimated)
Study completionMar 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Superficial Skin and Soft Tissue Infections Caused by Gram-positive BacteriaStudies 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: 72 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07790770
Sponsor's protocol ID: F021-01-001
Status last verified: Jul 2026
First submitted: 30 Jul 2026
Last updated: 27 Aug 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, PK Characteristics of CMS-F021 Following Single and Multiple Topical Administrations in Healthy Participants
ClinicalTrials.gov ID: NCT07790770
Acronym / sponsor ID: F021-01-001
Conditions: Superficial Skin and Soft Tissue Infections Caused by Gram-positive Bacteria
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 72 participants (estimated)
Lead sponsor: Dermavon Holdings LimitedIndustry (pharma, biotech, devices)
Study start: 21 Jul 2026 (actual)
Primary completion: Jan 2027 (estimated)
Study completion: Mar 2027 (estimated)
First posted: 27 Aug 2026 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
"Experimental: Single Dose Escalation of CMS-F021 5 sequential dose escalation cohorts - participant	Active comparator	Drug: CMS-F021 Gel"Drug: CMS-F021 Gel healthy participant"
"Experimental: Single Dose Escalation of placebo 5 sequential dose escalation cohorts - par	Placebo comparator	Drug: Drug: CMS-F021 Placebo Gel healthy participant"Drug: CMS-F021 Placebo Gel healthy participant"
"Experimental: Multiple Dose Escalation of CMS-F021 4 sequential dose escalation cohorts - participa	Active comparator	Drug: Drug: CMS-F021 Gel healthy participant"Drug: CMS-F021 Gel healthy participant"
"Experimental: Multiple Dose Escalation of placebo 4 sequential dose escalation cohorts - participan	Placebo comparator	Drug: "Drug: CMS-F021 Placebo Gel healthy participant""Drug: CMS-F021 Placebo Gel healthy participant"

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Participants must meet all of the following eligibility criteria to be enrolled in this study:
Voluntarily participate in this study and sign the informed consent form, able to understand and comply with all requirements and restrictions of this study, and capable of completing the study according to the protocol;
Age between 18 and 55 years (inclusive of boundary values, based on the date of signing the informed consent form), male or female;
Body mass index (BMI) within the range of 19.0-26.0 kg/m² (inclusive of boundary values) at screening, with female weight ≥ 45.0 kg and male weight ≥ 50.0 kg;
Participants with reproductive potential (including their partners) must have no plans for pregnancy, egg donation, or sperm donation from the date of signing the informed consent form until 3 months after the last dose of study medication, and must strictly adhere to contraceptive measures during this period.

Key exclusion criteria (5 listed)

Any participant meeting any of the following exclusion criteria will not be eligible for enrollment:
Those with a history of allergy or allergic constitution;
Abnormal vital signs, physical examination, laboratory tests (complete blood count, blood biochemistry, coagulation function, urinalysis), or 12-lead ECG findings at screening, judged by the investigator to have clinical significance;
History or clinical manifestations of significant diseases involving cardiovascular, respiratory, digestive, urinary/reproductive, hematologic, endocrine/metabolic, rheumatologic/immunologic, neurological/psychiatric, or musculoskeletal systems requiring medication and/or other treatments (including dietary restrictions and physical therapy), or considered by the investigator unsuitable for participation in this study; 4）Those with a history of severe skin diseases;
5) Evidence of current acute skin infection, or history of recurrent or chronic severe skin infections; 6) Researchers believe there may be some skin conditions that could interfere with skin assessment; 7) Use of any prescription or non-prescription medication (including herbal medicines, vitamins, minerals, and dietary supplements) within 2 weeks before dosing or within at least five half-lives (whichever is longer); 8) Participation in any other clinical trial involving drugs or medical devices within 3 months prior to screening, or planning to participate in such trials during this study, or still within the 5 half-life window of a previous investigational agent (whichever is longer); 9) History of drug abuse within the past 6 months, or positive results in any drug abuse screening test; 10) Weekly alcohol consumption exceeding 14 units within the past 3 months (1 unit = 360 mL beer, 150 mL wine, or 45 mL spirits), or positive alcohol breath test result, or inability to abstain from alcohol during the study; 11) Average daily smoking of more than 5 cigarettes within the past 3 months, or inability to discontinue use of any tobacco products during the study; 12) Pregnant or breast feeding females; 13) Difficulty with venipuncture (e.g., history of needle phobia or fainting due to blood draw), or poor venous access deemed unsuitable by the investigator; 14) Blood donation or blood loss ≥ 400 mL within 3 months prior to screening, or receipt of blood transfusion or blood products, or plan to donate blood during the study period; 15) Any other condition determined by the investigator to be unsuitable for participation in this study.

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
CMS-F021 GelSingle Dose	Drug	"Experimental: Single Dose Escalation of CMS-F021 5 sequential dose escalation cohorts - participant
Drug: CMS-F021 Placebo Gel healthy participantSingle Dose	Drug	"Experimental: Single Dose Escalation of placebo 5 sequential dose escalation cohorts - par
Drug: CMS-F021 Gel healthy participantMultiple Dose	Drug	"Experimental: Multiple Dose Escalation of CMS-F021 4 sequential dose escalation cohorts - participa
"Drug: CMS-F021 Placebo Gel healthy participant"Multiple Dose	Drug	"Experimental: Multiple Dose Escalation of placebo 4 sequential dose escalation cohorts - participan

Primary outcome

Change from baseline to each visit point in vital signs (temperature, blood pressure, heart rate, respiratory rate)
Time frame: through study completion,an average of 4 days or 10 days
Measured using electronic sphygmomanometer/thermometer according to standard procedures, record actual values at each visit point, and assess abnormal values.
Incidence rate of abnormal findings in comprehensive systemic physical examination
Time frame: through study completion,an average of 4 days or 10 days
Record abnormal physical examination findings by system (cardiovascular, respiratory, digestive, etc.), summarize the number and incidence rate of abnormalities in each system, and categorize them as related or unrelated to the study drug.
Hematology, biochemistry, urinalysis ，and Coagulation Profilelaboratory test indicators
Time frame: through study completion,an average of 4 days or 10days
The tests include complete blood count (WBC, RBC, Hb, etc.), blood biochemistry (ALT, AST, Cr, etc.), urinalysis ，and Coagulation Profile; changes from baseline were calculated, and the incidence of abnormal values was summarized according to CTCAE 6.0 grading.
12-lead electrocardiogram QTc interval, heart rate, and incidence of morphological abnormalities
Time frame: through study completion,an average of 4 days or 10days
Collected using standard 12-lead ECG equipment,with the number and incidence rate of QTc interval changes, heart rate abnormalities, and morphological abnormalities summarized.
Skin Irritation Score
Time frame: through study completion,an average of 4 days or 10days
Skin reactions will be assessed using the skin irritation scoring scale specified in the FDA and CDE guidance documents, Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs and Technical Guidance for Clinical Trials Evaluating Adhesion and Irritation/Sensitization of Transdermal and Topical Delivery Systems for Chemical Generic Drugs (Trial Implementation).

3 secondary outcomes

Maximum plasma drug concentration (Cmax)
Time frame: Through 48 hours post-dose
Tmax
Time frame: Through 48 hours post-dose
Area under the curve (AUC0-t)
Time frame: Through 48 hours post-dose

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 27 Aug 2026.
Individual participant dataSharing planned: No

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.

HAN WU contact

86-0755-82418801

h.wu@cms.net.cn

MEIXIA WANG principal investigator

Beijing Jishuitan Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Aug 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. 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?

Contact HAN WU (86-0755-82418801, h.wu@cms.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline to each visit point in vital signs (temperature, blood pressure, heart rate, respiratory rate) (time frame: through study completion,an average of 4 days or 10 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07790770.

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 27 Aug 2026.