IPFPhase 1NCT07493031
A PhaseⅠ Study of HW252001 in Healthy Subjects
A Phase 1 study testing HW252001 in people with IPF, run by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. at 1 site in China.
Trial summary
This is a phase 1, randomized, double-blind, placebo-controlled, Single/multiple ascending doses (SAD/MAD) study of HW252001 in healthy subjects. This study aims to evaluate the safety, tolerability, pharmacokinetics and Pharmacodynamics of HW252001. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- IPF
- What is being tested?
- HW252001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2026to 11 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- The participant must sign informed consent prior to the trial, understand the trial's content, procedures, and potential adverse reactions, and be able to complete the study in accordance with the trial protocol requirements.
- Healthy male or female subjects, aged ≥18 and ≤55 years on the day of signing the informed consent form.
- During the screening period, male participants must weigh ≥50 kg, and female participants must weigh ≥45 kg. Body Mass Index (BMI) = weight (kg) / height² (m²), and must be within the range of 19 kg/m² to 26 kg/m².
Who cannot join
- Subjects with a history of malignant tumors (except for cancer with confirmed cure or remission for ≥5 years, radically resected basal or squamous cell skin cancer, carcinoma in situ of the cervix, and resected colonic polyps);
- Subjects judged by the investigator to have any condition or disorder that may affect the absorption, metabolism, and/or excretion of the study drug.
- Subjects with severe infection, severe trauma, or major surgery within 3 months prior to the screening or baseline period; or those with planned surgery during the trial period.
- Subjects with a history of blood donation or significant blood loss (≥400 mL) within 8 weeks prior to the screening or baseline period, or those who have received a blood transfusion within 4 weeks prior to the screening or baseline period; or those who intend to donate blood during the trial period.
- Subjects with a positive result for any of the following at screening: Hepatitis B virus surface antigen (HBsAg), human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, or hepatitis C virus antibody.
- Subjects with a history of heavy smoking (averaging >5 cigarettes per day) within 4 weeks prior to screening or baseline, or those unable to discontinue the use of any tobacco products during the trial period.
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- Subjects with an average daily alcohol intake exceeding 15g (equivalent to 450 mL of beer, 150 mL of wine, or approximately 50 mL of low-alcohol liquor) within 4 weeks prior to the screening or baseline period; or those unable to abstain from alcohol during the trial; or those with a positive breath alcohol test at baseline.
- Subjects with a history of drug abuse or drug dependency prior to screening or baseline; or those with a positive urine drug test at baseline.
- Subjects who consumed excessive amounts of tea, coffee, or caffeine-containing beverages (averaging more than 8 cups per day, 250 mL per cup) within 48 hours prior to the first dose.
- Subjects with specific dietary requirements who are unable to comply with the unified diet.
- Subjects allergic to any component of the study drug; or those with a history of allergic diseases or a predisposition to allergies.
- Subjects with dysphagia, difficulty with venous blood collection, or physical conditions that cannot tolerate intensive blood sampling.
- Subjects judged by the investigator as unsuitable to participate in this trial for any other reason.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430100
JingLin Wang, Doctor, +86 13871116418, linlinvc202@163.com
About this study
Official title: A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HW252001 Tablets After Single and Multiple Dosing in Healthy Subjects
This is a phase 1, randomized, double-blind, placebo-controlled, Single/multiple ascending doses (SAD/MAD) study of HW252001 in healthy subjects. This study aims to evaluate the safety, tolerability, pharmacokinetics and Pharmacodynamics of HW252001.
- Conditions
- IPF
- Being tested
- HW252001, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HW252001Drug
HW252001 will be administered as oral tablets at assigned dose levels within each cohort in Part 1 (SAD) and Part 2 (MAD).
PlaceboDrug
Placebo will be administered as oral tablets at assigned dose levels within each cohort in Part 1 (SAD) and Part 2 (MAD).
| Study group | Role | What they receive |
|---|---|---|
| HW252001 | Experimental | Single or multiple oral dose of HW252001 Receives: Drug: HW252001 |
| Placebo | Placebo comparator | Single or multiple oral dose of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and severity of treatment emergent adverse events (TEAEs)
To assess the safety and tolerability of HW252001
Measured: up to 11 days
Secondary outcomes (2)
Cmax
PK Paramete
Measured: up to 11 days
Tmax
PK Paramete
Measured: up to 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start31 Mar 2026 (estimated)
- Primary completion11 Dec 2026 (estimated)
- Study completion11 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPFStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493031
- Sponsor's protocol ID
- HW252001-101
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this stage, it is not planned that any IPD information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HW252001 Tablets After Single and Multiple Dosing in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07493031
- Acronym / sponsor ID
- HW252001-101
- Conditions
- IPF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 11 Dec 2026 (estimated)
- Study completion
- 11 Dec 2026 (estimated)
- First posted
- 25 Mar 2026 (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 phase 1, randomized, double-blind, placebo-controlled, Single/multiple ascending doses (SAD/MAD) study of HW252001 in healthy subjects. This study aims to evaluate the safety, tolerability, pharmacokinetics and Pharmacodynamics of HW252001.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HW252001 | Experimental | Drug: HW252001Single or multiple oral dose of HW252001 |
| Placebo | Placebo comparator | Drug: PlaceboSingle or multiple oral dose of placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The participant must sign informed consent prior to the trial, understand the trial's content, procedures, and potential adverse reactions, and be able to complete the study in accordance with the trial protocol requirements.
- Healthy male or female subjects, aged ≥18 and ≤55 years on the day of signing the informed consent form.
- During the screening period, male participants must weigh ≥50 kg, and female participants must weigh ≥45 kg. Body Mass Index (BMI) = weight (kg) / height² (m²), and must be within the range of 19 kg/m² to 26 kg/m².
Key exclusion criteria (13 listed)
- Subjects with a history of malignant tumors (except for cancer with confirmed cure or remission for ≥5 years, radically resected basal or squamous cell skin cancer, carcinoma in situ of the cervix, and resected colonic polyps);
- Subjects judged by the investigator to have any condition or disorder that may affect the absorption, metabolism, and/or excretion of the study drug.
- Subjects with severe infection, severe trauma, or major surgery within 3 months prior to the screening or baseline period; or those with planned surgery during the trial period.
- Subjects with a history of blood donation or significant blood loss (≥400 mL) within 8 weeks prior to the screening or baseline period, or those who have received a blood transfusion within 4 weeks prior to the screening or baseline period; or those who intend to donate blood during the trial period.
- Subjects with a positive result for any of the following at screening: Hepatitis B virus surface antigen (HBsAg), human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, or hepatitis C virus antibody.
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 |
|---|---|---|
| HW252001HW252001 will be administered as oral tablets at assigned dose levels within each cohort in Part 1 (SAD) and Part 2 (MAD). | Drug | HW252001 |
| PlaceboPlacebo will be administered as oral tablets at assigned dose levels within each cohort in Part 1 (SAD) and Part 2 (MAD). | Drug | Placebo |
Primary outcome
The number and severity of treatment emergent adverse events (TEAEs)
Time frame: up to 11 days
To assess the safety and tolerability of HW252001
2 secondary outcomes
Cmax
Time frame: up to 11 days
Tmax
Time frame: up to 11 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No. At this stage, it is not planned that any IPD information will be shared.
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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.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HW252001 in people with IPF, run by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. at 1 site in China.
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 3 inclusion and 13 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: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number and severity of treatment emergent adverse events (TEAEs) (time frame: up to 11 days). 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 27 Mar 2026.