A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of HuL001

NCT04540770 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: HuL001-CT-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (10)

• Frequency, severity, and causality of adverse events (AEs), including solicited local AEs

  Frequency, severity, and causality of adverse events (AEs), including solicited local AEs

  70 Days in Part A and 84 Days in Part B

• Proportion of subjects who report clinically significant abnormal findings in physical examination

  Proportion of subjects who report clinically significant abnormal findings in physical examination

  70 Days in Part A and 84 Days in Part B

• Change from baseline in blood pressure

  Change from baseline in systolic and diastolic blood pressure

  70 Days in Part A and 84 Days in Part B

• Change from baseline in respiratory rate

  Change from baseline in respiratory rate

  70 Days in Part A and 84 Days in Part B

• Change from baseline in heart rate

  Change from baseline in heart rate

  70 Days in Part A and 84 Days in Part B

• Change from baseline in body temperature

  Change from baseline in body temperature

  70 Days in Part A and 84 Days in Part B

• Change from baseline in hematology assessments

  The hematology assessments including hematocrit, hemoglobin, platelet count, red blood cell (RBC) count, white blood cell (WBC) count (total and differential), reticulocyte count and absolute neutrophil count.

  70 Days in Part A and 84 Days in Part B

• Change from baseline in biochemistry assessments

  The biochemistry assessments including alanine aminotransferase (ALT), albumin, alkaline phosphatase (ALP), amylase, aspartate aminotransferase (AST), bicarbonate, blood urea nitrogen (BUN), calcium, chloride, creatinine, creatinine kinase, gamma glutamyl transferase (GGT), glucose, lactic acid dehydrogenase (LDH), lipid panel (low and high density lipids cholesterol, triglycerides; total cholesterol), magnesium, potassium, sodium, total bilirubin, total protein and uric acid.

  70 Days in Part A and 84 Days in Part B

• Change from baseline in electrocardiogram (ECG) results (including PR, QRS, QT, QTcF, and RR intervals)

  Change from baseline in electrocardiogram (ECG) results

  70 Days in Part A and 84 Days in Part B

• Tolerability of HuL001 in terms of frequency of events meeting the intra-cohort stopping criteria within the tolerability observation period

  Tolerability of HuL001 in terms of frequency of events meeting the intra-cohort stopping criteria within the tolerability observation period

  70 Days in Part A and 84 Days in Part B

Secondary Outcomes (8)

• PK of single ascending doses of HuL001 in healthy subjects and multiple doses of HuL001 in IPF subjects- maximum observed concentration (Cmax)

  70 Days in Part A and 84 Days in Part B

• PK of single ascending doses of HuL001 in healthy subjects and multiple doses of HuL001 in IPF subjects-time to reach Cmax (tmax)

  70 Days in Part A and 84 Days in Part B

• PK of single ascending doses of HuL001 in healthy subjects and multiple doses of HuL001 in IPF subjects- area under the curve from zero up to time t (AUC0-t)

  70 Days in Part A and 84 Days in Part B

• PK of single ascending doses of HuL001 in healthy subjects and multiple doses of HuL001 in IPF subjects- apparent total clearance of the drug from plasma (CL/F)

  70 Days in Part A and 84 Days in Part B

• PK of single ascending doses of HuL001 in healthy subjects and multiple doses of HuL001 in IPF subjects- terminal half-life (t1/2)

  70 Days in Part A and 84 Days in Part B

Other Outcomes (1)

• Mean percent change from baseline of migrated PBMCs after single dose of HuL001 in healthy subjects (Cohort 1 of Part A only) and after the first and third doses of HuL001 administration in IPF subjects (Part B).

  0 Days in Part A and 0 Days,28 Days in Part B

Study Arms (4)

Part A 1 (1 mg/kg HuL001)

PLACEBO COMPARATOR

6 healthy subjects will be enrolled and randomized to receive 1 dose of HuL001 (n = 4) or 1 dose of placebo (n = 2).

Drug: HuL001

Part A 2 (3 mg/kg HuL001)

PLACEBO COMPARATOR

6 healthy subjects will be enrolled and randomized to receive 1 dose of HuL001 (n = 4) or 1 dose of placebo (n = 2).

Drug: HuL001

Part A 3 (5 mg/kg HuL001)

PLACEBO COMPARATOR

6 healthy subjects will be enrolled and randomized to receive 1 dose of HuL001 (n = 4) or 1 dose of placebo (n = 2).

Drug: HuL001

Part B 1 (Selected Dose)

EXPERIMENTAL

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.

Drug: HuL001

Interventions

HuL001 DRUG

Anti-ENO1 monoclonal antibody

Also known as: Anti-Enolase 1 monoclonal antibody

Part A 1 (1 mg/kg HuL001); Part A 2 (3 mg/kg HuL001); Part A 3 (5 mg/kg HuL001); Part B 1 (Selected Dose)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Subjects presenting with any of the following criteria will be excluded from participating in the study:
• Healthy and IPF Subjects
• Female subjects who are breastfeeding, pregnant, or planning to become pregnant during the study period.
• The Investigator considers that the subject is not in the condition to participate in this study.
• Evidence or history of clinically significant (as judged by the Investigator) hematologic, renal, endocrine, pulmonary (except for IPF subjects), gastrointestinal, cardiovascular (except for IPF subjects), hepatic, psychiatric, immunologic, metabolic, urologic, dermatologic, neurologic or allergic diseases, or other significant clinical findings within 3 months prior to screening.
• Has participated in a clinical trial and has received an investigational product (IP) within 60 days prior to screening.
• Previous history of anaphylaxis and severe allergic reaction, generation of neutralizing antibodies, or hypersensitivity to albumin or a protein-based therapeutic, or any other monoclonal antibody.
• Had blood donation within 60 days or had blood donation over 250 mL within 90 days prior to screening, or cannot commit to stopping blood donation during the study period.
• Receipt of vaccination within 1 month of screening or plan to receive vaccination during the study.
• Have significant active infection (acute or chronic) within 28 days prior to screening.
• Healthy Subjects only
• A positive test for Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface antigen, or Hepatitis C antibody result within 3 months of screening.
• Abnormal baseline blood tests exceeding any of the limits defined below:
• ALT or aspartate transaminase (AST) \> 1.5x ULN, ALP and bilirubin \> 1.5x ULN (isolated bilirubin \> 1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%)
• Total white blood cell count \< 2,500/mm3; subjects with lymphocyte count less than the Lower Limit of Normal (LLN) may be included at the Investigator's discretion; platelet count \< 95,000/mm3

Sponsors & Collaborators

• HuniLife Biotechnology, Inc.: lead

Study Sites (2)

Mackay Memorial Hospital

New Taipei City, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Hao-Chien Wang, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 7, 2020
• Study Start: August 31, 2021
• Primary Completion: March 4, 2022
• Study Completion: January 19, 2024
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)