ClinicalTrials.gg
Not yet recruitingNCT07936032Updated Nov 13, 2026

Phase I Study to Evaluate Single and Multiple Oral Doses of HW281171 Tablets in Healthy Participants

A Phase 1 interventional study of HW281171 tablets and Placebo tablets in Chronic Urticaria, sponsored by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. · Phase 1, Interventional, and Treatment

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 34 studies in Chronic Urticaria with a site in China — 16 open to participants now, 20 under way, 5 of them phase 3. Chronic Urticaria · China.

Planned enrollment
18th of 30
80 · median 110
Started
2026
with 10 others
Phase 1
7 of 34
3 open now
Primary completion
2027-08
later than 16 of 19 live
Registered
34th of 34
by date

Among the 34 studies in Chronic Urticaria with a site in China, this one is the 18th largest by planned enrollment of the 30 interventional ones that give a count, is one of 11 that started in 2026, is one of 7 in phase 1, reaches primary completion later than 16 of the 19 other live ones, and was the 34th registered.

Chronic Urticaria

196 studies on the registry are indexed under Chronic Urticaria; 48 are open to participants now.

Browse Chronic Urticaria studies →

Open to participants now

16 of the 34 studies in Chronic Urticaria with a site in China are open now. Recruiting first, the newest first:

10 more — sign in →

All 16 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 25 Chronic Urticaria studies recruiting now, 11 (44%) set no upper age limit and 10 (40%) stop at 75 or younger; 1 takes children under 18; 6 take healthy volunteers.

This study: 18 Years to 45 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 34 studies in Chronic Urticaria with a site in China, or all of them as a file.
02

Study summary

This phase 1 study aims to evaluate the safety, tolerability and pharmacokinetic profiles of HW281171 in healthy Participants. The study consists of three parts: Part A (Single-Dose Escalation Study), Part B (Food Effect and Metabolite Study), and Part C (Multiple-Dose Escalation Study).

03

Conditions studied

  • Chronic Urticaria

Browse trials for

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants sign the form prior to the initiation of any study procedures.
  • Healthy male and female participants aged 18 to 45 years (inclusive), with no less than 3 participants of a single gender.
  • Female participants have a body weight of ≥45.00 kg, male participants have a body weight of ≥50.00 kg, and the (BMI) ranges from 19.0 to 26.0 kg/m\^2 (inclusive).
  • Participants whose vital signs, physical examination, 12-lead , laboratory tests, abdominal B-ultrasound and posteroanterior chest X-ray results at screening or on Day -1 are judged by the Investigator to be normal or abnormal without clinical significance.
  • Participants agree to have no fertility plan and no sperm/egg donation plan from the time of signing the informed consent form until 3 months after study withdrawal, and are willing to practice abstinence or use highly effective methods during this period.
  • Participants can communicate well with the Investigator, understand and comply with all requirements of this study, and fully understand the study purpose, nature, methods and potential Adverse Events.

Exclusion criteria

Exclusion Criteria:

  • Participants with a history of drug or food allergy, allergic diseases, or allergic diathesis (allergic to two or more substances), or with confirmed allergy to any component or analogue of the product.
  • Participants with any past or current severe or chronic diseases of the circulatory, endocrine, nervous, digestive, respiratory, hematological, immune, psychiatric systems or metabolic disorders, or any other diseases judged by the investigator that may interfere with trial results.
  • Participants with a history of gastrointestinal, hepatic or renal diseases affecting drug absorption or metabolism, or known or suspected diseases affecting drug intake, transport, absorption, distribution, metabolism or excretion; participants who have undergone surgeries affecting drug absorption or metabolism (appendectomy excluded).
  • Participants with abnormal examination results specified in the protocol at screening or on Day -1.
  • Participants with a history of drug abuse, drug dependence, or positive drug screening results.
  • Participants with positive results for any of antibody, virus surface antigen, virus antibody, or treponema pallidum specific antibody.
  • Female participants who are pregnant, lactating at screening or during the trial, or have a pregnancy test result above the , or have had unprotected sexual intercourse within 2 weeks before screening.
  • Participants with prior or concomitant medications/non-drug interventions specified in the protocol.
  • Participants who have participated in any clinical trial of drugs or medical devices within 90 days before screening (participation in a clinical trial is defined as receiving or using the investigational drug/device).
  • Participants with severe trauma or surgical operation within 3 months before screening; participants who plan to receive surgery during the trial or within two weeks after trial completion.
  • Participants who have donated blood or experienced a total blood loss of ≥400 ml within 3 months before the first dose.
  • Participants with difficult venous access and intolerance to venipuncture.
  • Participants with a smoking history within 3 months before screening (average daily consumption >5 cigarettes), or who cannot stop using any tobacco products during the trial.
  • Participants with an average weekly alcohol intake of more than 14 alcohol units within 3 months before screening (1 alcohol unit is approximately 360 ml beer, or 45 ml spirits with 40 Percentage alcohol content, or 150 ml wine), or positive alcohol breath test, or who cannot abstain from alcohol during the trial.
  • Participants consuming excessive tea, coffee or caffeinated beverages on average every day (more than 8 cups, 1 cup = 250 ml) within 48 hours before the first dose, or who cannot stop consuming tea, coffee or caffeinated beverages during the trial; participants who have consumed special diets within 48 hours before the first dose (including pitaya, mango, lime, pomelo, carambola, orange, grapefruit or grapefruit products and other fruits or corresponding juices that may affect drug metabolism), or other special diets affecting drug absorption, distribution, metabolism or excretion.
  • Participants with special dietary requirements and unable to follow the unified diet.
  • Participants with other factors judged by the investigator to be unsuitable for participating in the clinical trial.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Part A:HW281171

    Single dose of HW281171 tablets

    Drug: HW281171 tablets

  • Placebo comparator
    Part A:Placebo

    Single dose of Placebo tablets

    Drug: Placebo tablets

  • Experimental
    Part B:Sequence A

    Single dose of HW281171 tablets under fasting-fed sequence

    Drug: HW281171 tablets

  • Experimental
    Part B:Sequence B

    Single dose of HW281171 tablets under fed-fasting sequence

    Drug: HW281171 tablets

  • Experimental
    Part C:HW281171

    Multiple doses of HW281171 tablets

    Drug: HW281171 tablets

  • Placebo comparator
    Part C:Placebo

    Multiple doses of Placebo tablets

    Drug: Placebo tablets

Interventions

  • DrugHW281171 tablets

    Administered orally daily at pre-specified dose and frequency.

  • DrugPlacebo tablets

    Administered orally daily at pre-specified dose and frequency.

06

What researchers measure

Primary outcomes

  1. The number and severity of treatment emergent adverse events (TEAEs)

    To assess the safety and tolerability of single or multiple doses of HW281171 tablets in healthy participants.

    Time frame: Up to 1 month

Secondary outcomes

  1. The maximum serum concentration (Cmax)

    Pharmacokinetic parameter

    Time frame: Up to 1 month

  2. The Area Under the Curve from dosing to the time of the last measured concentration (AUC0-t)

    Pharmacokinetic parameter

    Time frame: Up to 1 month

  3. The time to reach Cmax (Tmax)

    Pharmacokinetic parameter

    Time frame: Up to 1 month

  4. The Half life (t1/2)

    Pharmacokinetic parameter

    Time frame: Up to 1 month

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Aug 2027, 9 months later.

Of 15 phase 1 interventional studies under Chronic Urticaria, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 21. This study's planned 9 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2026
First posted
Nov 13, 2026
StartEst.
Nov 18, 2026
Primary completionEst.
Aug 2027
CompletionEst.
Sep 2027
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07936032
Lead sponsor
Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
Responsible party
Sponsor
First posted
Nov 13, 2026
Start date
Nov 18, 2026 (estimated)
Primary completion
Aug 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Nov 13, 2026

Study contacts

Lifei Liu
Contact
liulifei@renfu.com.cn
+86-27-87173753

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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