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

Status: Completed
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a first-in-human, two-part, Phase 1 study that will characterize the safety, tolerability, PK, and immunogenicity of HuL001.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
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⁃ 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

Locations
Other Locations
Taiwan
Mackay Memorial Hospital
New Taipei City
National Taiwan University Hospital
Taipei
Time Frame
Start Date: 2021-08-31
Completion Date: 2024-01-19
Participants
Target number of participants: 24
Treatments
Placebo_comparator: Part A 1 (1 mg/kg HuL001)
6 healthy subjects will be enrolled and randomized to receive 1 dose of HuL001 (n = 4) or 1 dose of placebo (n = 2).
Placebo_comparator: Part A 2 (3 mg/kg HuL001)
6 healthy subjects will be enrolled and randomized to receive 1 dose of HuL001 (n = 4) or 1 dose of placebo (n = 2).
Placebo_comparator: Part A 3 (5 mg/kg HuL001)
6 healthy subjects will be enrolled and randomized to receive 1 dose of HuL001 (n = 4) or 1 dose of placebo (n = 2).
Experimental: Part B 1 (Selected Dose)
At the end of Part A, the SRC will review the accumulated unblinded data of safety, tolerability, PK (any available data), and immunogenicity (any available data) to select a dose to initiate Part B in IPF subjects. Part B will be conducted in multiple-dose, uncontrolled, and open-label manner to explore the safety, tolerability, PK, and immunogenicity in IPF subjects. Only one cohort will be enrolled to receive 3 repeated doses of the selected HuL001 dose, which will be administered bi-weekly.~A total of 6 IPF subjects will be enrolled in this multiple-dose cohort.
Authors
Chao-Hsien Chen
Sponsors
Leads: HuniLife Biotechnology, Inc.

This content was sourced from clinicaltrials.gov