Idiopathic Pulmonary FibrosisPhase 1NCT04540770
A Phase 1 Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of HuL001
A Phase 1 study testing HuL001 in people with Idiopathic Pulmonary Fibrosis, run by HuniLife Biotechnology, Inc. at 2 sites in Taiwan.
Trial summary
This is a first-in-human, two-part, Phase 1 study that will characterize the safety, tolerability, PK, and immunogenicity of HuL001. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- HuL001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesTaiwan
- Study dates
- 31 Aug 2021to 19 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
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- 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
Who cannot join
- 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.
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- 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
- Creatinine > 2x ULN, calculated creatinine clearance < 60 mL/min (per Cockcroft \& Gault)
- International Normalized Ratio (INR) larger than upper limit of the normal reference range (0.9 - 1.3)
- Current chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 14 days or 5 half-lives (whichever is longer) prior to screening, unless in the opinion of the Investigator the medication will not interfere with the study procedures or compromise subject safety.
- Previous exposure to any chimeric, humanized, or human monoclonal antibody, whether licensed or investigational.
- Using tobacco products, nicotine products (patches, gum etc.) within 6 months prior to screening.
- IPF Subjects only
- A positive test for Human Immunodeficiency Virus (HIV) antibody, 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) > 2x ULN, ALP and bilirubin > 2x ULN (isolated bilirubin > 2x 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
- Creatinine > 2x ULN, calculated creatinine clearance < 60 mL/min (per Cockcroft \& Gault)
- International Normalized Ratio (INR) larger than upper limit of the normal reference range (0.9 - 1.3)
- Interstitial lung disease other than IPF.
- Medical conditions, e.g., recent MI/stroke, severe chronic heart failure, pulmonary hypertension, or cancers, unsuitable for the study in the opinion of Investigator.
- Acute IPF exacerbation during Screening.
- Relevant airways obstruction (pre-bronchodilator FEV1/FVC< 0.7).
- History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies.
- Treatment with prescription drugs for IPF within 5 half-lives of the drug, whichever is longer, prior to dosing.
- Major surgery (major according to the investigator's assessment) planned during the course of the trial. (Being on a transplant list is allowed).
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Mackay Memorial Hospital
New Taipei City
National Taiwan University Hospital
Taipei
About this study
Official title: 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.
Read the detailed description
This is a first-in-human, two-part, Phase 1 study that will characterize the safety, tolerability, PK, and immunogenicity of HuL001 after single ascending doses in healthy subjects followed by multiple doses in IPF subjects. The study will be conducted in 2 parts:
- Part A will enroll 3 single ascending doses (SAD) cohorts in healthy subjects. (HuL001:Placebo=4:2)
- Part B will enroll 1 multiple-dose cohort in IPF subjects. The proposed dose of HuL001 will be selected from the single-dose range of HuL001 evaluated in the healthy subjects of Part A. (HuL001=6)
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- HuL001
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HuL001Drug
Also called Anti-Enolase 1 monoclonal antibody
Anti-ENO1 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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. Receives: Drug: HuL001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency, severity, and causality of adverse events (AEs), including solicited local AEs
Frequency, severity, and causality of adverse events (AEs), including solicited local AEs
Measured: 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
Measured: 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
Measured: 70 Days in Part A and 84 Days in Part B
Change from baseline in respiratory rate
Change from baseline in respiratory rate
Measured: 70 Days in Part A and 84 Days in Part B
Change from baseline in heart rate
Change from baseline in heart rate
Measured: 70 Days in Part A and 84 Days in Part B
Change from baseline in body temperature
Change from baseline in body temperature
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
PK of single ascending doses of HuL001 in healthy subjects and multiple doses of HuL001 in IPF subjects- maximum observed concentration (Cmax)
Measured: 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)
PK of single ascending doses of HuL001 in healthy subjects and multiple doses of HuL001 in IPF subjects-time to reach Cmax (tmax)
Measured: 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)
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)
Measured: 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)
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)
Measured: 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)
PK of single ascending doses of HuL001 in healthy subjects and multiple doses of HuL001 in IPF subjects- terminal half-life (t1/2)
Measured: 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 volume of distribution during terminal phase (Vz/F)
PK of single ascending doses of HuL001 in healthy subjects and multiple doses of HuL001 in IPF subjects- apparent volume of distribution during terminal phase (Vz/F)
Measured: 70 Days in Part A and 84 Days in Part B
Proportion of subjects with positive anti-HuL001 antibodies
Proportion of subjects with positive anti-HuL001 antibodies
Measured: 70 Days in Part A and 84 Days in Part B
Change from baseline in serum levels of cytokines
Change from baseline in serum levels of cytokines
Measured: 70 Days in Part A and 84 Days in Part B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start31 Aug 2021
- Primary completion4 Mar 2022
- Study completion19 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- HuniLife Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hao-Chien Wang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540770
- Sponsor's protocol ID
- HuL001-CT-101
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2020
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04540770
- Acronym / sponsor ID
- HuL001-CT-101
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- HuniLife Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 4 Mar 2022 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human, two-part, Phase 1 study that will characterize the safety, tolerability, PK, and immunogenicity of HuL001.
Detailed description
This is a first-in-human, two-part, Phase 1 study that will characterize the safety, tolerability, PK, and immunogenicity of HuL001 after single ascending doses in healthy subjects followed by multiple doses in IPF subjects. The study will be conducted in 2 parts:
- Part A will enroll 3 single ascending doses (SAD) cohorts in healthy subjects. (HuL001:Placebo=4:2)
- Part B will enroll 1 multiple-dose cohort in IPF subjects. The proposed dose of HuL001 will be selected from the single-dose range of HuL001 evaluated in the healthy subjects of Part A. (HuL001=6)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A 1 (1 mg/kg HuL001) | Placebo comparator | Drug: HuL0016 healthy subjects will be enrolled and randomized to receive 1 dose of HuL001 (n = 4) or 1 dose of placebo (n = 2). |
| Part A 2 (3 mg/kg HuL001) | Placebo comparator | Drug: HuL0016 healthy subjects will be enrolled and randomized to receive 1 dose of HuL001 (n = 4) or 1 dose of placebo (n = 2). |
| Part A 3 (5 mg/kg HuL001) | Placebo comparator | Drug: HuL0016 healthy subjects will be enrolled and randomized to receive 1 dose of HuL001 (n = 4) or 1 dose of placebo (n = 2). |
| Part B 1 (Selected Dose) | Experimental | Drug: HuL001At 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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).
Key exclusion criteria (35 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HuL001Also: Anti-Enolase 1 monoclonal antibodyAnti-ENO1 monoclonal antibody | Drug | 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) |
Primary outcome
Frequency, severity, and causality of adverse events (AEs), including solicited local AEs
Time frame: 70 Days in Part A and 84 Days in Part B
Frequency, severity, and causality of adverse events (AEs), including solicited local AEs
Proportion of subjects who report clinically significant abnormal findings in physical examination
Time frame: 70 Days in Part A and 84 Days in Part B
Proportion of subjects who report clinically significant abnormal findings in physical examination
Change from baseline in blood pressure
Time frame: 70 Days in Part A and 84 Days in Part B
Change from baseline in systolic and diastolic blood pressure
Change from baseline in respiratory rate
Time frame: 70 Days in Part A and 84 Days in Part B
Change from baseline in respiratory rate
Change from baseline in heart rate
Time frame: 70 Days in Part A and 84 Days in Part B
Change from baseline in heart rate
Change from baseline in body temperature
Time frame: 70 Days in Part A and 84 Days in Part B
Change from baseline in body temperature
Change from baseline in hematology assessments
Time frame: 70 Days in Part A and 84 Days in Part B
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.
Change from baseline in biochemistry assessments
Time frame: 70 Days in Part A and 84 Days in Part B
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.
Change from baseline in electrocardiogram (ECG) results (including PR, QRS, QT, QTcF, and RR intervals)
Time frame: 70 Days in Part A and 84 Days in Part B
Change from baseline in electrocardiogram (ECG) results
Tolerability of HuL001 in terms of frequency of events meeting the intra-cohort stopping criteria within the tolerability observation period
Time frame: 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
8 secondary outcomes
PK of single ascending doses of HuL001 in healthy subjects and multiple doses of HuL001 in IPF subjects- maximum observed concentration (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 volume of distribution during terminal phase (Vz/F)
Time frame: 70 Days in Part A and 84 Days in Part B
Proportion of subjects with positive anti-HuL001 antibodies
Time frame: 70 Days in Part A and 84 Days in Part B
Change from baseline in serum levels of cytokines
Time frame: 70 Days in Part A and 84 Days in Part B
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hao-Chien Wang, MD principal investigator
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HuL001 in people with Idiopathic Pulmonary Fibrosis, run by HuniLife Biotechnology, Inc. at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency, severity, and causality of adverse events (AEs), including solicited local AEs (time frame: 70 Days in Part A and 84 Days in Part B). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.