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Tests treatment safety and results for Healthy
Official title A First-in-Human SAD/MAD Study to Evaluate Safety, Tolerability and PK of ENC0653 Ointment in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT07684196
What this study is testing
What is Low Dose, 10%BSA?
Low Dose, 10%BSA is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for healthy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- The subject signs the informed consent form (ICF) prior to enrollment after full disclosure of study procedures and requirements. The subject...
- Aged ≥ 18 years and ≤ 55 years on the date of signing the informed consent form, male or female.
- Male people with body weight ≥ 50 kg, female people with body weight ≥ 45 kg, and body mass index (BMI) within the range of 18.0-32.0 kg/m²...
- No ulceration, injury, sunburn, erythema, rash, or abnormal warmth, as well as tattoos, birthmarks, skin scars, or skin perforations shall be present...
- The subject gives voluntary consent to employ adequate contraceptive methods from 2 weeks prior to dosing until 1 month after the last study visit...
You likely can't join if
- The subject has any skin disorders deemed by the investigator to be a study contraindication or to compromise assessment of the application region...
- Presence of any of the following high-risk conditions: history of deep vein thrombosis, arterial thrombosis, or pulmonary embolism; family history of...
- Presence of any active cutaneous infections of acute bacterial, fungal, or viral (e.g., herpes simplex, herpes zoster, varicella, etc.) within 1 week...
- 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...
- 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...
See the full eligibility criteria
- 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...
- Aged ≥ 18 years and ≤ 55 years on the date of signing the informed consent form, male or female.
- Male people with body weight ≥ 50 kg, female people 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.
- 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...
- 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...
- 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...
- 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Xuhui District, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Xuhui District, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.