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 .
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).
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.
Parallel
RC010 Inhalation Powder
DrugParticipants were randomly assigned to the 0.1, 0.3, 0.75, 1.5 and 2 mg dose groups
RC010 Inhalation Powder placebo
DrugMatch to RC010 Inhalation Powder dose groups
The incidence of Treatment-emergent adverse events (TEAEs)
The severity of Treatment-emergent adverse events (TEAEs)
The incidence of Serious adverse events (SAEs)
The severity of Serious adverse events (SAEs)
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
AUC from time zero to infinity (AUC0-∞)
Maximum observed concentration (Cmax)
Time of maximum observed concentration (Tmax)
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This trial is not recruiting at the moment. You can still explore other options:
