NCT07684196招募中1 期
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
EnnovaBio1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2026年6月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Number and types of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) following ENC0653 ointment administration
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
- •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.
结局指标
主要结局
Number and types of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) following ENC0653 ointment administration
时间窗: D-28 to Day 4 (± 1) for SAD and D-28 to Day 11 (± 1) for MAD
次要结局
- Plasma drug concentrations(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)
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
1 期
A Phase I Study of PepGNP-ChikV in Healthy VolunteersChikungunyaChikungunya FeverNCT07394426Gylden Pharma Ltd40
尚未招募
1 期
Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Participants..Cutaneous Lupus ErythematosusSystemic Lupus ErythematosusNCT07408908Xiamen Amoytop Biotech Co., Ltd.48
招募中
1 期
Evaluate the Safety, Tolerability, PK, and PD of JMT206 Injection in Healthy ParticipantsNCT07419698Shanghai JMT-Bio Inc.44
尚未招募
1 期
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of ACT500 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Complicated With Chronic Hepatitis BNCT07589400Xiamen Amoytop Biotech Co., Ltd.24
已完成
1 期
A Phase 1 MAD Study of KINE-101 in Healthy VolunteersNCT07324642Kine Sciences Co., Ltd.24