HealthyPhase 1NCT06350279

A Phase I Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy Subjects

A Phase 1 study testing HSK39297 in people with Healthy, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase I, randomized, subject-blinded, placebo controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD),and food effect (FE) of HSK39297 following (1) a single ascending dose (part 1), (2) 10 days of multiple ascending dose (part 2), and (3) a single dose two-period… Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: HSK39297
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 1 siteChina
Study dates: 25 Dec 2023to 29 Sep 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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Voluntarily sign the informed consent form, understand the trialprocedures, and be willing to comply with all trial procedures andrestrictions;
18 years to 45 years (inclusive), male and female;
Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Bodymass index (BMI) : 18-26 kg/m2 (inclusive) ;
Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 3 months after the last dose administration.

Who cannot join

Have a history of severe and uncontrolled diseases, such ascardiovascular, respiratory, liver, gastrointestinal, endocrine,hematologic, mental/nervous systems diseases within 3 months prior to screening;
Have an infection that requires systematic treatment with antibiotics, antifungal, antiparasitic or antiviral drugs;
Have a clear history of capsular bacteria infection within 6 months before screening, inncluding but not limited to Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae B, etc.;
Have a history of TB infection or are currently infected with TB;
Have a history of any malignant tumors;
The abnormalities were clinically significant during the screening period, such as physical examination, vital signs, blood biochemistry, blood routine, coagulation, urine routine, blood pregnancy test, infectious diseases and X-ray;

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Subjects whose results of routine 12-lead electrocardiograms were inconsistent with normal heart conduction and function;
Previous or current gastrointestinal, liver, kidney, or other disease known to interfere with drug absorption, distribution, metabolism, or excretion;
Smoking more than 5 cigarettes per day within 3 months prior toscreening or smoking during the study;
Average alcohol intake is more than 14 unit per week (1unit=10g alcohol , 1 unit=285 mL 4.9% alcohol beer, or 30 mL 40% alcohol spirit, or 100mL 12% alcohol wine) within the 3 months prior to screening;
Have a history of drug abuse prior to screening, or positive urine drug screen at screening;
Have a history of high consumption of grapefruit juice, methylxanthinerich food or beverage (such as coffee, tea, cola, chocolate, energydrinks) ,consumption of grapefruit juice, methylxanthine-rich food within 48 hours before the administration;
Blood donation (or blood loss) ≥400 mL, or receiving blood products to improve anemia within 3 months prior to the screening;
Subjects who have a allergic to any component of HSK30297 or allergic history to opiates;
Any drug that inhibits or induces drug metabolism enzymes or P-gp inhibitor have been administered within 28 days prior to initial administration of the investigational drug;
Subjects who use any live vaccine within 30 days prior to screening;
Have participated in any clinical investigator within 3 months prior to screening;
A pregnant/lactating woman, or has a positive pregnancy test at screening or during the trial;
Not suitable for this study as judged by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Tongren Hospital
Beijing

Other trials in China

About this study

Official title: A Single and Multiple Ascending Dose Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy Subjects

Conditions: Healthy
Being tested: HSK39297
Keywords: HSK39297, healthy subjects, Phase I

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HSK39297Drug
50-600mg

Study groups in NCT06350279
Study group	Role	What they receive
HSK39297	Experimental	Single or multiple oral doses of HSK39297 Receives: Drug: HSK39297
Placebo	Experimental	Placebo Receives: Drug: HSK39297

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 single or multiple oral dose of HSK39297 in healthy adult volunteers
Measured: 9 days after single dose and 16 days after the first dose of multiple doses

Secondary outcomes (6)

AUC
Area under the plasma concentration versus time curve (AUC) on Day 1 and D10
Measured: Pre-dose to 168 hours post-dose
Cmax
The maximun plasma concentration of HSK39297
Measured: Pre-dose to 168 hours post-dose
Tmax
Time of maximum concentration of HSK39297
Measured: Pre-dose to 168 hours post-dose
t1/2
half-life
Measured: Pre-dose to 168 hours post-dose
AP change
change from baselin of the alternative pathway activity
Measured: Pre-dose to 168 hours post-dose
Bb
change from baselin of the concentration of Bb
Measured: Pre-dose to 168 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Dec 202329 Sep 2024

First posted5 Apr 2024
Study start25 Dec 2023
Primary completion2 Aug 2024
Study completion29 Sep 2024

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.
More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06350279
Sponsor's protocol ID: HSK39297-101
Status last verified: Dec 2024
First submitted: 1 Apr 2024
Last updated: 1 Jan 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single and Multiple Ascending Dose Study to Assess the Safety,Tolerability, PK, PD, and Food Effect of HSK39297 in Healthy Subjects
ClinicalTrials.gov ID: NCT06350279
Acronym / sponsor ID: HSK39297-101
Conditions: Healthy
Keywords: HSK39297, healthy subjects, Phase I
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
Study start: 25 Dec 2023 (actual)
Primary completion: 2 Aug 2024 (actual)
Study completion: 29 Sep 2024 (actual)
First posted: 5 Apr 2024 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
HSK39297	Experimental	Drug: HSK39297Single or multiple oral doses of HSK39297
Placebo	Experimental	Drug: HSK39297Placebo

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Voluntarily sign the informed consent form, understand the trialprocedures, and be willing to comply with all trial procedures andrestrictions;
18 years to 45 years (inclusive), male and female;
Male subjects weight ≥50 kg and female subjects weight ≥45 kg. Bodymass index (BMI) : 18-26 kg/m2 (inclusive) ;
Subjects are willing to voluntarily use effectivecontraceptives from screening to at least 3 months after the last dose administration.

Key exclusion criteria (19 listed)

Have a history of severe and uncontrolled diseases, such ascardiovascular, respiratory, liver, gastrointestinal, endocrine,hematologic, mental/nervous systems diseases within 3 months prior to screening;
Have an infection that requires systematic treatment with antibiotics, antifungal, antiparasitic or antiviral drugs;
Have a clear history of capsular bacteria infection within 6 months before screening, inncluding but not limited to Neisseria meningitidis, Streptococcus pneumoniae, Haemophilus influenzae B, etc.;
Have a history of TB infection or are currently infected with TB;
Have a history of any malignant tumors;

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
HSK3929750-600mg	Drug	HSK39297, Placebo

Primary outcome

The number and severity of treatment emergent adverse events (TEAEs) .
Time frame: 9 days after single dose and 16 days after the first dose of multiple doses
To assess the safety and tolerability of single or multiple oral dose of HSK39297 in healthy adult volunteers

6 secondary outcomes

AUC
Time frame: Pre-dose to 168 hours post-dose
Cmax
Time frame: Pre-dose to 168 hours post-dose
Tmax
Time frame: Pre-dose to 168 hours post-dose
t1/2
Time frame: Pre-dose to 168 hours post-dose
AP change
Time frame: Pre-dose to 168 hours post-dose
Bb
Time frame: Pre-dose to 168 hours post-dose

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 1 Jan 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.

The record lists no contact. Use the official record to reach the sponsor.

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 HSK39297 in people with Healthy, run by Haisco Pharmaceutical Group Co., Ltd. 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 4 inclusion and 19 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 1 Jan 2025. 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. 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?

The number and severity of treatment emergent adverse events (TEAEs) . (time frame: 9 days after single dose and 16 days after the first dose of multiple doses). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06350279.

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 1 Jan 2025.