HealthyPhase 1NCT07737496
A Study of HW243040 in Healthy Participants
A Phase 1 study testing HW243040 in people with Healthy, run by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. at 1 site in China.
Trial summary
This is a randomised, double-blind, placebo-controlled clinical trial intended to evaluate the safety, tolerability and pharmacokinetic profiles of HW243040 following single and multiple administrations in healthy study participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HW243040
- 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
- 20 Aug 2026to 31 May 2027
- 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
- Informed consent must be obtained/signed prior to trial participation.
- Aged between 18 and 55 years old, both healthy males and females are eligible.
- Female participates must have a body weight of ≥ 45 kg and male participates ≥ 50 kg, with a body mass index (BMI) ranging from 19 to 26 kg/m^2.
Who cannot join
- History or presence of any clinically severe disorders of urinary, cardiovascular, endocrine, nervous, gastrointestinal, respiratory, hematologic, immune systems, psychiatric illnesses or metabolic abnormalities; or other conditions judged by the Investigator to confound trial outcomes, e.g., intestinal diseases (irritable bowel syndrome), urinary tract infections.
- 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).
- Any conditions or diseases that, in the Investigator's judgment, may affect the absorption, metabolism and/or excretion of the investigational product.
- History of drug abuse or dependence.
- Hypersensitivity to any ingredient of the study drug，or history of allergic disorders or allergic diathesis.
- Any other condition that, in the opinion of the investigator, renders the participant unsuitable to participate in the study.
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, 1 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Guoping Yang, 86-0731-89918665, ygp9880@163.com
About this study
Official title: A Phase 1, Randomized, Double-Blind, Single-Center, Dose-Escalation, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HW243040 in Healthy Participants
This is a randomised, double-blind, placebo-controlled clinical trial intended to evaluate the safety, tolerability and pharmacokinetic profiles of HW243040 following single and multiple administrations in healthy study participants.
- Conditions
- Healthy
- Being tested
- HW243040, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HW243040Drug
HW243040 will be administered orally as a tablet.
PlaceboDrug
Placebo will be administered orally as a tablet.
| Study group | Role | What they receive |
|---|---|---|
| HW243040 group | Experimental | Single or multiple dose of HW243040 will be administered orally. Receives: Drug: HW243040 |
| Placebo group | Placebo comparator | Single or multiple dose of placebo will be administered orally. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse events
Measured: Up to day 11
Secondary outcomes (4)
Maximum Concentration (Cmax) of HW243040
Measured: Up to day 11
Area Under the Concentration Versus Time Curve (AUC) of HW243040
Measured: Up to day 11
Time for Cmax (Tmax) of HW243040
Measured: Up to day 11
Half-life of HW243040
Measured: Up to day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start20 Aug 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- 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
- NCT07737496
- Sponsor's protocol ID
- HW243040-101
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Single-Center, Dose-Escalation, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HW243040 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07737496
- Acronym / sponsor ID
- HW243040-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 30 Jul 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 randomised, double-blind, placebo-controlled clinical trial intended to evaluate the safety, tolerability and pharmacokinetic profiles of HW243040 following single and multiple administrations in healthy study participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HW243040 group | Experimental | Drug: HW243040Single or multiple dose of HW243040 will be administered orally. |
| Placebo group | Placebo comparator | Drug: PlaceboSingle or multiple dose of placebo will be administered orally. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Informed consent must be obtained/signed prior to trial participation.
- Aged between 18 and 55 years old, both healthy males and females are eligible.
- Female participates must have a body weight of ≥ 45 kg and male participates ≥ 50 kg, with a body mass index (BMI) ranging from 19 to 26 kg/m^2.
Key exclusion criteria (6 listed)
- History or presence of any clinically severe disorders of urinary, cardiovascular, endocrine, nervous, gastrointestinal, respiratory, hematologic, immune systems, psychiatric illnesses or metabolic abnormalities; or other conditions judged by the Investigator to confound trial outcomes, e.g., intestinal diseases (irritable bowel syndrome), urinary tract infections.
- 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).
- Any conditions or diseases that, in the Investigator's judgment, may affect the absorption, metabolism and/or excretion of the investigational product.
- History of drug abuse or dependence.
- Hypersensitivity to any ingredient of the study drug，or history of allergic disorders or allergic diathesis.
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 |
|---|---|---|
| HW243040HW243040 will be administered orally as a tablet. | Drug | HW243040 group |
| PlaceboPlacebo will be administered orally as a tablet. | Drug | Placebo group |
Primary outcome
The incidence and severity of adverse events
Time frame: Up to day 11
4 secondary outcomes
Maximum Concentration (Cmax) of HW243040
Time frame: Up to day 11
Area Under the Concentration Versus Time Curve (AUC) of HW243040
Time frame: Up to day 11
Time for Cmax (Tmax) of HW243040
Time frame: Up to day 11
Half-life of HW243040
Time frame: Up to day 11
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 Aug 2026.
- 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.
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 HW243040 in people with Healthy, 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 6 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: looking for participants now, as of the sponsor's last update on 27 Aug 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?
Contact Lifei Liu (86-027-87173753, liulifei@renfu.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of adverse events (time frame: Up to day 11). 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 Aug 2026.