HealthyPhase 1NCT07684196
A First-in-Human SAD/MAD Study to Evaluate Safety, Tolerability and PK of ENC0653 Ointment in Healthy Adult Subjects
A Phase 1 study testing Low Dose, 10%BSA, Low Dose, 20%BSA and Middle Dose, 20%BSA in people with Healthy, run by EnnovaBio at 1 site in China.
Trial summary
This is a FIH, randomized, double-blind, single-center, placebo-controlled, dose -escalation clinical study to evaluate the safety, tolerability and pharmacokinetics of ENC0653 ointment following single and multiple topical dermal administration in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Low Dose, 10%BSA, Low Dose, 20%BSA and Middle Dose, 20%BSA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2026to 30 Dec 2026
- 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
- The subject signs the informed consent form (ICF) prior to enrollment after full disclosure of study procedures and requirements. The subject understands the necessity of following study rules and completing all assessments on time, is fully informed of study procedures, and potential adverse reactions, and is able to complete the study in accordance with the protocol requirements.
- Aged ≥ 18 years and ≤ 55 years on the date of signing the informed consent form, male or female.
- Male subjects with body weight ≥ 50 kg, female subjects with body weight ≥ 45 kg, and body mass index (BMI) within the range of 18.0-32.0 kg/m² (inclusive).
- No ulceration, injury, sunburn, erythema, rash, or abnormal warmth, as well as tattoos, birthmarks, skin scars, or skin perforations shall be present on the target application regions at screening and prior to dosing.
- The subject gives voluntary consent to employ adequate contraceptive methods from 2 weeks prior to dosing until 1 month after the last study visit, and to refrain from sperm or egg donation during this period.
Who cannot join
- The subject has any skin disorders deemed by the investigator to be a study contraindication or to compromise assessment of the application region, including psoriasis, eczema, acne, atopic dermatitis, dysplastic nevi, other dermatologic lesions, or a history of cutaneous malignancy.
- Presence of any of the following high-risk conditions: history of deep vein thrombosis, arterial thrombosis, or pulmonary embolism; family history of thromboembolism (e.g., myocardial infarction or cerebral infarction in family members); history of malignancy; serious organ or systemic disease, immune-mediated disease (including but not limited to rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, Crohn's disease, psoriatic arthritis, etc.), or any diseases deemed by the investigator to render the subject unsuitable for enrollment in this study.
- Presence of any active cutaneous infections of acute bacterial, fungal, or viral (e.g., herpes simplex, herpes zoster, varicella, etc.) within 1 week prior to signing the ICF; or any acute or chronic infections requiring systemic treatment with antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to signing the ICF.
- History of severe trauma or major surgery within 3 months prior to screening; plan to receive surgery during the trial or within 2 weeks after completion of the trial.
- History of active tuberculosis, or clinical symptoms/signs or chest X-ray findings suggestive of active tuberculosis.
- Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody (TP-Ab).
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- Pregnant, breast-feeding and/or lactating women.
- ALT, AST or TBiL ≥1.5ULN
- Has received any live vaccines within 1 month prior to screening or intend to receive a live vaccine during the study period or within 30 days after the last dose.
- The subject who has participated in any clinical trial of investigational drugs or medical devices within 3 months prior to screening (or 5 half-lives, whichever is longer).
- Other factors considered inappropriate for inclusion in this study at the discretion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Xuhui Central Hospital
Shanghai, Xuhui District, 200237
Yun Liu, 86-021-36682212, yliu@shxh-centerlab.com
About this study
Official title: A Phase 1 Randomized, Double-Blind, Single-Center, Placebo-Controlled Single Ascending Dose and Multiple Ascending Dose (SAD/MAD) Study by Topical Dermal Administration to Evaluate the Safety, Tolerability, and Pharmacokinetics of ENC0653 Ointment in Healthy Adult Subjects
This is a FIH, randomized, double-blind, single-center, placebo-controlled, dose -escalation clinical study to evaluate the safety, tolerability and pharmacokinetics of ENC0653 ointment following single and multiple topical dermal administration in healthy adult subjects.
Up to 56 subjects will be enrolled at a single site in up to 4 cohorts in Part A (SAD study), and up to 3 cohorts in Part B (MAD study). Part A is for the single dose use of IP, while Part B is twice-daily use for 7 consecutive days and once daily use on Day 8. Each cohort will include 8 subjects (6 receiving ENC0653 ointment and 2 receiving placebo ointment).
Dosing will be escalated on a review of safety, tolerability, and available PK data by a Safety Review Committee (SRC).
- Conditions
- Healthy
- Being tested
- Low Dose, 10%BSA, Low Dose, 20%BSA, Middle Dose, 20%BSA, High Dose, 20%BSA, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Dose, 10%BSADrug
Topical dermal administration
Low Dose, 20%BSADrug
Topical dermal administration
Middle Dose, 20%BSADrug
Topical dermal administration
High Dose, 20%BSADrug
Topical dermal administration
Low Dose, 20%BSADrug
Topical dermal administration
Middle Dose, 20%BSADrug
Topical dermal administration
High Dose, 20%BSADrug
Topical dermal administration
PlaceboDrug
Topical dermal administration
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose, Low Dose, 10%BSA | Experimental | Topical dermal administration Receives: Drug: Low Dose, 10%BSA |
| Single Ascending Dose, Low Dose, 20%BSA | Experimental | Topical dermal administration Receives: Drug: Low Dose, 20%BSA |
| Single Ascending Dose, Middle Dose, 20%BSA | Experimental | Topical dermal administration Receives: Drug: Middle Dose, 20%BSA |
| Single Ascending Dose, High Dose, 20%BSA | Experimental | Topical dermal administration Receives: Drug: High Dose, 20%BSA |
| Multiple Ascending Dose, Low Dose, 20%BSA | Experimental | Topical dermal administration Receives: Drug: Low Dose, 20%BSA |
| Multiple Ascending Dose, Middle Dose, 20%BSA | Experimental | Topical dermal administration Receives: Drug: Middle Dose, 20%BSA |
| Multiple Ascending Dose, High Dose, 20%BSA | Experimental | Topical dermal administration Receives: Drug: High Dose, 20%BSA |
| Single/Multiple Ascending Dose, Placebo Ointment | Placebo comparator | Placebo ointment for topical dermal administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and types of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) following ENC0653 ointment administration
Measured: D-28 to Day 4 (± 1) for SAD and D-28 to Day 11 (± 1) for MAD
Secondary outcomes (1)
Plasma drug concentrations
Measured: Single Ascending Dose (SAD) part: up to Day 4, 72 hours post dose; Multiple Ascending Dose (MAD) part: up to Day 11, 72 hours post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start17 Jun 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EnnovaBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07684196
- Sponsor's protocol ID
- ENC0653-P1-CN-01
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-Blind, Single-Center, Placebo-Controlled Single Ascending Dose and Multiple Ascending Dose (SAD/MAD) Study by Topical Dermal Administration to Evaluate the Safety, Tolerability, and Pharmacokinetics of ENC0653 Ointment in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT07684196
- Acronym / sponsor ID
- ENC0653-P1-CN-01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- EnnovaBioIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 6 Jul 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.
This is a FIH, randomized, double-blind, single-center, placebo-controlled, dose -escalation clinical study to evaluate the safety, tolerability and pharmacokinetics of ENC0653 ointment following single and multiple topical dermal administration in healthy adult subjects.
Up to 56 subjects will be enrolled at a single site in up to 4 cohorts in Part A (SAD study), and up to 3 cohorts in Part B (MAD study). Part A is for the single dose use of IP, while Part B is twice-daily use for 7 consecutive days and once daily use on Day 8. Each cohort will include 8 subjects (6 receiving ENC0653 ointment and 2 receiving placebo ointment).
Dosing will be escalated on a review of safety, tolerability, and available PK data by a Safety Review Committee (SRC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose, Low Dose, 10%BSA | Experimental | Drug: Low Dose, 10%BSATopical dermal administration |
| Single Ascending Dose, Low Dose, 20%BSA | Experimental | Drug: Low Dose, 20%BSATopical dermal administration |
| Single Ascending Dose, Middle Dose, 20%BSA | Experimental | Drug: Middle Dose, 20%BSATopical dermal administration |
| Single Ascending Dose, High Dose, 20%BSA | Experimental | Drug: High Dose, 20%BSATopical dermal administration |
| Multiple Ascending Dose, Low Dose, 20%BSA | Experimental | Drug: Low Dose, 20%BSATopical dermal administration |
| Multiple Ascending Dose, Middle Dose, 20%BSA | Experimental | Drug: Middle Dose, 20%BSATopical dermal administration |
| Multiple Ascending Dose, High Dose, 20%BSA | Experimental | Drug: High Dose, 20%BSATopical dermal administration |
| Single/Multiple Ascending Dose, Placebo Ointment | Placebo comparator | Drug: PlaceboPlacebo ointment for topical dermal administration |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The subject signs the informed consent form (ICF) prior to enrollment after full disclosure of study procedures and requirements. The subject understands the necessity of following study rules and completing all assessments on time, is fully informed of study procedures, and potential adverse reactions, and is able to complete the study in accordance with the protocol requirements.
- Aged ≥ 18 years and ≤ 55 years on the date of signing the informed consent form, male or female.
- Male subjects with body weight ≥ 50 kg, female subjects with body weight ≥ 45 kg, and body mass index (BMI) within the range of 18.0-32.0 kg/m² (inclusive).
- No ulceration, injury, sunburn, erythema, rash, or abnormal warmth, as well as tattoos, birthmarks, skin scars, or skin perforations shall be present on the target application regions at screening and prior to dosing.
- The subject gives voluntary consent to employ adequate contraceptive methods from 2 weeks prior to dosing until 1 month after the last study visit, and to refrain from sperm or egg donation during this period.
Key exclusion criteria (11 listed)
- The subject has any skin disorders deemed by the investigator to be a study contraindication or to compromise assessment of the application region, including psoriasis, eczema, acne, atopic dermatitis, dysplastic nevi, other dermatologic lesions, or a history of cutaneous malignancy.
- Presence of any of the following high-risk conditions: history of deep vein thrombosis, arterial thrombosis, or pulmonary embolism; family history of thromboembolism (e.g., myocardial infarction or cerebral infarction in family members); history of malignancy; serious organ or systemic disease, immune-mediated disease (including but not limited to rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, Crohn's disease, psoriatic arthritis, etc.), or any diseases deemed by the investigator to render the subject unsuitable for enrollment in this study.
- Presence of any active cutaneous infections of acute bacterial, fungal, or viral (e.g., herpes simplex, herpes zoster, varicella, etc.) within 1 week prior to signing the ICF; or any acute or chronic infections requiring systemic treatment with antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to signing the ICF.
- History of severe trauma or major surgery within 3 months prior to screening; plan to receive surgery during the trial or within 2 weeks after completion of the trial.
- History of active tuberculosis, or clinical symptoms/signs or chest X-ray findings suggestive of active tuberculosis.
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 |
|---|---|---|
| Low Dose, 10%BSATopical dermal administration | Drug | Single Ascending Dose, Low Dose, 10%BSA |
| Low Dose, 20%BSATopical dermal administration | Drug | Single Ascending Dose, Low Dose, 20%BSA |
| Middle Dose, 20%BSATopical dermal administration | Drug | Single Ascending Dose, Middle Dose, 20%BSA |
| High Dose, 20%BSATopical dermal administration | Drug | Single Ascending Dose, High Dose, 20%BSA |
| Low Dose, 20%BSATopical dermal administration | Drug | Multiple Ascending Dose, Low Dose, 20%BSA |
| Middle Dose, 20%BSATopical dermal administration | Drug | Multiple Ascending Dose, Middle Dose, 20%BSA |
| High Dose, 20%BSATopical dermal administration | Drug | Multiple Ascending Dose, High Dose, 20%BSA |
| PlaceboTopical dermal administration | Drug | Single/Multiple Ascending Dose, Placebo Ointment |
Primary outcome
Number and types of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) following ENC0653 ointment administration
Time frame: D-28 to Day 4 (± 1) for SAD and D-28 to Day 11 (± 1) for MAD
1 secondary outcome
Plasma drug concentrations
Time frame: Single Ascending Dose (SAD) part: up to Day 4, 72 hours post dose; Multiple Ascending Dose (MAD) part: up to Day 11, 72 hours post last 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 6 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Low Dose, 10%BSA, Low Dose, 20%BSA and Middle Dose, 20%BSA in people with Healthy, run by EnnovaBio 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 5 inclusion and 11 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 6 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and types of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) following ENC0653 ointment administration (time frame: D-28 to Day 4 (± 1) for SAD and D-28 to Day 11 (± 1) for MAD). 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 6 Jul 2026; AzTrials last refreshed its copy on 29 Oct 2026.