A Phase 1 Single and Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of HuL001 in Healthy Volunteers and Idiopathic Pulmonary Fibrosis Subjects
This is a first-in-human, two-part, Phase 1 study that will characterize the safety, tolerability, PK, and immunogenicity of HuL001.
⁃ Subjects who meet the following criteria will be eligible to participate in the study:
⁃ Healthy and IPF Subjects
• Female subjects and male subjects with female partners of child-bearing potential must agree to use adequate contraception (2 forms of birth control, one of which must be a barrier method). This criterion must be followed from the time of the first dose of treatment.
• Able to understand, sign the written informed consent form, and follow the study procedures.
• With no clinically significant abnormalities in vital signs, 12-lead ECG, and clinical laboratory assessments at screening as judged by the Investigator
• Corrected QT interval using Fridericia's (QTcF) \< 450 milliseconds (msec).
⁃ Healthy Subjects only
• Aged between 20 and 55 years of age inclusive, at the time of signing the informed consent.
• Alanine aminotransferase (ALT), alkaline phosphatase (ALP), and bilirubin ≤ 1.5x upper limit of normal (ULN) (isolated bilirubin \> 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%).
• Body weight ≥ 50 kilogram (kg), \< 75 kg and body mass index (BMI) within the range 19.0 - 29.9 kg/m2 (inclusive).
⁃ IPF Subjects only
• Aged between 40 and 90 years of age inclusive, at the time of signing the informed consent.
• FVC≥ 40% and DLCO≥30%
• Alanine aminotransferase (ALT), alkaline phosphatase (ALP), and bilirubin ≤ 2x upper limit of normal (ULN) (isolated bilirubin \> 2xULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%).
• Diagnosis of IPF as defined by ATS/ERS/JRS/ALAT guidelines (Raghu 2018) within the past 7 years prior to study participation.
• Patients who are ineffective with an approved therapy (i.e., pirfenidone or nintedanib), or who are judged by the Investigator to be unsuitable for receiving approved therapy