A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of RC010 Inhalation Powder in Healthy Participants

Официальное название

A Phase Ia Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of RC010 Inhalation Powder in Healthy Chinese Participants

Обзор

This is a Phase 1A, first in human, randomized, double-blinded, placebo-controlled, dose escalation study of RC010 in healthy adult volunteers. RC010 is a small-molecule drug , being developed as a novel therapeutic treatment for patients with Idiopathic Pulmonary fibrosis (IPF). This study aims to evaluate the safety, tolerability and pharmacokinetics of RC010 after Single ascending doses .

Вмешательства

• Препарат RC010 Inhalation Powder
  Participants were randomly assigned to the 0.1, 0.3, 0.75, 1.5 and 2 mg dose groups
• Препарат RC010 Inhalation Powder placebo
  Match to RC010 Inhalation Powder dose groups

Первичные конечные точки

• The incidence of Treatment-emergent adverse events (TEAEs) [Срок оценки: Day1-Day14]
• The severity of Treatment-emergent adverse events (TEAEs) [Срок оценки: Day 1-Day 14]
• The incidence of Serious adverse events (SAEs) [Срок оценки: Day 1-Day 14]
• The severity of Serious adverse events (SAEs) [Срок оценки: Day 1- Day 14]
• Number of participants with abnormal clinically significant 12-lead electrocardiogram (ECG) parameters [Срок оценки: Day 1-Day 14]
• Number of participants with abnormal clinically significant clinical laboratory results [Срок оценки: Day 1- Day 14]
• Number of patients with abnormal clinically significant results from physical examination [Срок оценки: Day 1-Day 14]

Вторичные конечные точки (5)

• Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) [Срок оценки: Day 1-Day 14]
• AUC from time zero to infinity (AUC0-∞) [Срок оценки: Day 1-Day 14]
• Maximum observed concentration (Cmax) [Срок оценки: Day 1-Day 14]
• Time of maximum observed concentration (Tmax) [Срок оценки: Day 1 - Day 14]
• Terminal elimination half life(t1/2) [Срок оценки: Day 1-Day 14]

Критерии участия

Критерии включения

• Be able to communicate well with the researchers, fully understand the objectives and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form;
• Aged between 18 and 55 years inclusive, of both genders;
• Have a body mass index (BMI) between 19.0 kg/m² and 28.0 kg/m² inclusive, and a body weight of ≥ 50.0 kg for males or ≥ 45.0 kg for females;
• Have no plans for childbearing, sperm donation or egg donation from the time of voluntarily signing the informed consent form until 90 days after the last dose, and voluntarily adopt medically approved contraceptive measures (including their partners, see Appendix 1 for details).

Критерии исключения

• Received clinical trial medication or participated in other medical research activities within 3 months prior to screening, and is deemed unsuitable for study enrollment by the investigator.
• Has a history of or currently suffers from clinically unstable diseases/abnormalities of the cardiovascular, respiratory, endocrine, metabolic, renal, hepatic, gastrointestinal, dermatological, infectious, hematological, nervous, or neuropsychiatric systems, which the investigator judges to interfere with study conduct.
• Has a history of glaucoma, functional constipation, benign prostatic hyperplasia, urinary tract obstruction, or similar conditions.
• Has a history of severe oral/maxillofacial deformities, or presents with oral candidiasis, ulcers, or other mucosal lesions at screening that may affect oral inhalation administration.
• Has a past or current history of bleeding risk-increasing diseases (e.g., acute gastritis, active bleeding peptic ulcers), clinically significant thrombocytopenia/anemia (Hb < 80 g/L and/or PLT < 100×10⁹/L), active pathological bleeding, or intracranial hemorrhage history.
• Suffered from lower respiratory tract infection, or upper respiratory tract infection requiring antibiotic therapy, within 6 weeks prior to screening/enrollment.
• Has a history of chronic obstructive pulmonary disease (COPD) or other respiratory diseases, including but not limited to tuberculosis infection, α-1 antitrypsin deficiency, cystic fibrosis, symptomatic asthma, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary arterial hypertension, pulmonary edema, or interstitial lung disease.
• Received any live vaccine (excluding influenza vaccine) within 30 days prior to screening, or plans to receive vaccines during the study period.
• Has a history of drug allergies, specific allergic conditions (e.g., asthma, urticaria, eczema), is an atopic individual (allergic to ≥2 types of drugs/foods/pollen), or has a known allergy to any component of RC010 Inhalation Powder.
• Lost blood or donated blood > 400 mL within 3 months prior to screening (excluding female menstrual blood loss), or intends to donate blood during the study or within 1 month post-study.
• Underwent surgery within 1 month prior to screening, or plans to undergo surgery during the study period.
• Excessively consumed tea, coffee, or caffeinated beverages (average ≥ 8 cups/day, 250 mL/cup) within 6 months prior to screening.
• Ingested caffeine/xanthine-containing products (e.g., coffee, tea, cola, chocolate), poppy seed-containing foods, or CYP2C8/CYP3A4-affecting substances (e.g., limes, grapefruit/juice, pomelos) within 48 hours prior to investigational product administration.
• Used hepatic drug-metabolizing enzyme inhibitors/inducers within 28 days prior to screening; or used prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health supplements within 14 days prior to screening. For long half-life drugs, the washout period shall be at least 5 times the drug half-life.
• Has special dietary requirements and cannot comply with the unified study diet.
• Has venous blood collection difficulties, or a history of needle phobia/hematophobia.
• Is a heavy smoker (smoking ≥ 5 cigarettes/day within 3 months prior to the first dose), cannot comply with smoking prohibition during the study, or has a positive smoking test result.
• Has a history of regular alcohol consumption within 6 months prior to screening (women > 14 standard units/week, men > 21 standard units/week; 1 unit = 14g alcohol), cannot abstain from alcohol during the study, or has a positive breath alcohol test result.
• Has a history of drug abuse, or has a positive drug abuse screening result (including benzodiazepines, methamphetamine, cocaine, morphine, ketamine, tetrahydrocannabinol carboxylic acid).
• Has clinically significant abnormal findings in screening physical examination, vital signs, laboratory tests (blood/urine/stool routine, biochemistry, coagulation, thyroid function, etc.), abdominal B-ultrasound, or chest X-ray, as judged by the investigator.
• Has positive screening results for HBsAg, anti-HCV, TPPA, or HIV-Ag/Ab.
• Has screening pulmonary function test results showing FEV₁/predicted value ≤ 80%, FVC ≤ 80% of predicted value, or other clinically significant abnormalities.
• Is a pregnant/lactating woman, or has a positive screening blood pregnancy test result.
• Has clinically significant abnormal 12-lead ECG findings at screening (e.g., bradycardia/tachycardia, QTcF ≥ 450 ms \[male\]/≥ 470 ms \[female\], arrhythmia), as judged by the investigator.
• Has screening serum potassium concentration < 3.5 mmol/L.
• Is unwilling/unable to correctly use the inhaler for investigational product administration, or fails inhalation training.
• Is deemed unsuitable for study participation due to other circumstances judged by the investigator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• China-Japan Friendship Hospital — Пекин

Идентификаторы

NCT: NCT07528703 · RC010-CN101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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