Healthy VolunteerPhase 1NCT07580794
First-in-human Study of HSK56630 in Healthy Subjects
A Phase 1 study testing HSK56630 in people with Healthy Volunteer, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in Australia.
Trial summary
This is a first-in-human, single ascending dose (SAD) study in healthy adult participants. This is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and PK of HSK56630 in healthy adult participants and preliminarily evaluate the PD of HSK56630. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- HSK56630
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Jun 2026to 31 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
- Adult males and females between ≥ 18 and ≤ 60 years (inclusive) at Screening.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 with a body weight ≥ 50 kg (males) or ≥45 kg (females) at Screening.
- Participants with normal results or non-clinically significant (NCS) abnormal results in the opinion of the PI or delegate for a comprehensive examination, including physical examination, vital signs examination, laboratory tests (hematology, biochemistry, coagulation and urinalysis), chest X-ray and abdominal ultrasound.
- Female participants are eligible to participate if they are not pregnant, not breastfeeding. Male participants must agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior to screening and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom plus effective contraception methods for their female partner.
- Able and willing to attend the necessary visits to the study site.
Who cannot join
- Participants with any clinically significant medical history that may affect the safety evaluation or in vivo process of IP as judged by the PI or delegate, including central nervous, cardiovascular, digestive, respiratory, urinary, blood, immune and endocrine diseases. Participants with childhood asthma (resolved) can be included at the discretion of the PI.
- Underlying physical or psychological medical condition that, in the opinion of the PI or delegate, would make the participant unlikely to comply with the protocol or complete the study per protocol.
- Participants having special dietary requirements that cannot be accommodated by the unit or that may interfere with study safety or data (e.g. exclusively vegan diet).
- Participants who have taken any prescription drugs (excluding contraception) or herbal medicines within 14 days prior to dosing, or have taken any over-the-counter drugs or dietary supplements (including vitamin and calcium supplements) within 7 days prior to dosing; or participants still within 5 half-lives of a drug prior to dosing.
- Alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) >1.5 × upper limit of normal (ULN) at Screening or Day -1. Repeat testing at Screening is acceptable for out-of-range values following approval by the PI or delegate.
- Participants who have been vaccinated 4 weeks prior to first dose or plan to be vaccinated during the study.
Show all 20Show fewer
- Participants who have taken any other investigational product, participated in any other clinical trial, or participated in other medical research activities within 30 days or 5 half-lives whichever is longer prior to first dose and are unsuitable for participating in this study as judged by the PI or delegate.
- Ascertained or presumptive hypersensitivity (including allergies) to any ingredient of the IP; history of other significant allergies or anaphylaxis, as determined by the PI or delegate.
- Participants who have lost or donated more than 400 mL of blood (excluding menstrual blood loss in females) within 3 months prior to first dose, or plan to donate blood during the study or within 1 month after the end of the study.
- Participants who drink excessive tea, coffee or caffeinated beverages (over 8 cups per day on average, 250 mL per cup) within 6 months prior to Screening, or those who cannot abstain from them on Day -1 and during confinement study in the CRU.
- Current smoker who smoke more than 5 cigarettes (or equivalent for other nicotine-containing products) per day within 3 months prior to the first dose, or those who cannot abstain from smoking tobacco or the use of nicotine-containing products during the confinement period.
- Participants who regularly drink more than 14 standard units of alcohol per week for females and more than 21 standard units of alcohol per week for males; 1 standard unit contains 10 g of alcohol, such as 285 mL of beer, 30 mL of 40% spirits or 100 mL of wine within 6 months prior to Screening or those who cannot abstain from alcohol on Day -1 and during the confinement study; or those with positive alcohol breath test.
- Substance abuse-related disorder or a history of drug, and/or substance abuse deemed significant by the PI or delegate at Screening or a positive urine drug screen on Screening or Day -1 (including amphetamine, benzodiazepine, cocaine, methamphetamines, opiates, THC, MDMA, tricyclic antidepressants, barbiturates).
- Participants with clinically significant abnormal 12-lead electrocardiogram (ECG) results as judged by the PI or delegate or with a corrected QTc (formula: QTcF = QT/RR1/3) interval ≤ 350 msec or greater than 450 msec in males and 470 msec in females.
- Participants with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), treponema pallidum antibody (Syphilis TP Ab) or human immunodeficiency virus antibody (HIV Ab) at Screening.
- Participants with positive result for quantiFERON gold at Screening.
- Participants with estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m2 (using the CKD-EPI equation).
- History or presence of a condition associated with significant immunosuppression.
- Exposure to any drugs that cause significant immunosuppression (including experimental therapies as part of a clinical study) within 4 months or 5 half lives (whichever is longer), prior to Screening.
- Participants who may not be able to complete the study for other reasons, cannot comply with the requirements of the study, or are unsuitable to participate in the study as judged by the PI or delegate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Veritus Research Pty Ltd
Bayswater, Victoria, 3153
Benjamin Snyder, 03 8736 1750, bensnyder@veritusresearch.com
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HSK56630 in Healthy Participants
This is a first-in-human, single ascending dose (SAD) study in healthy adult participants. This is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and PK of HSK56630 in healthy adult participants and preliminarily evaluate the PD of HSK56630.
- Conditions
- Healthy Volunteer
- Being tested
- HSK56630, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK56630Drug
Orally administered tablets of HSK56630
PlaceboDrug
Orally administered tablets of placebo
| Study group | Role | What they receive |
|---|---|---|
| Drug | Experimental | Not described Receives: Drug: HSK56630 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of single ascending doses of HSK56630 in healthy adult subjects
Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 6.0
Measured: 8 days
Secondary outcomes (6)
To evaluate the pharmacokinetics (PK) of a single dose of HSK56630 in healthy participants.
Peak plasma Concentration (Cmax)
Measured: 8 days
To evaluate the pharmacokinetics (PK) of a single dose of HSK56630 in healthy participants.
Area under the drug concentration-time curve (AUC)
Measured: 8 days
To evaluate the pharmacokinetics (PK) of a single dose of HSK56630 in healthy participants.
Apparent terminal half-life (t½)
Measured: 8 days
To evaluate the pharmacokinetics (PK) of a single dose of HSK56630 in healthy participants.
Apparent total plasma clearance of drug (CL/F)
Measured: 8 days
To evaluate the pharmacokinetics (PK) of a single dose of HSK56630 in healthy participants.
Apparent volume of distribution after oral administration (Vz/F)
Measured: 8 days
To evaluate the pharmacodynamics (PD) of HSK56630.
Change from baseline of VAV1 protein levels
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start17 Jun 2026
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Veritus Research Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07580794
- Sponsor's protocol ID
- HSK56630-101
- Status last verified
- Jun 2026
- First submitted
- 17 Apr 2026
- Last updated
- 24 Jun 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 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HSK56630 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07580794
- Acronym / sponsor ID
- HSK56630-101
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Veritus Research Pty Ltd
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 May 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 first-in-human, single ascending dose (SAD) study in healthy adult participants. This is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and PK of HSK56630 in healthy adult participants and preliminarily evaluate the PD of HSK56630.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug | Experimental | Drug: HSK56630 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
- Adult males and females between ≥ 18 and ≤ 60 years (inclusive) at Screening.
- Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 with a body weight ≥ 50 kg (males) or ≥45 kg (females) at Screening.
- Participants with normal results or non-clinically significant (NCS) abnormal results in the opinion of the PI or delegate for a comprehensive examination, including physical examination, vital signs examination, laboratory tests (hematology, biochemistry, coagulation and urinalysis), chest X-ray and abdominal ultrasound.
- Female participants are eligible to participate if they are not pregnant, not breastfeeding. Male participants must agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior to screening and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom plus effective contraception methods for their female partner.
Key exclusion criteria (20 listed)
- Participants with any clinically significant medical history that may affect the safety evaluation or in vivo process of IP as judged by the PI or delegate, including central nervous, cardiovascular, digestive, respiratory, urinary, blood, immune and endocrine diseases. Participants with childhood asthma (resolved) can be included at the discretion of the PI.
- Underlying physical or psychological medical condition that, in the opinion of the PI or delegate, would make the participant unlikely to comply with the protocol or complete the study per protocol.
- Participants having special dietary requirements that cannot be accommodated by the unit or that may interfere with study safety or data (e.g. exclusively vegan diet).
- Participants who have taken any prescription drugs (excluding contraception) or herbal medicines within 14 days prior to dosing, or have taken any over-the-counter drugs or dietary supplements (including vitamin and calcium supplements) within 7 days prior to dosing; or participants still within 5 half-lives of a drug prior to dosing.
- Alkaline phosphatase (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) >1.5 × upper limit of normal (ULN) at Screening or Day -1. Repeat testing at Screening is acceptable for out-of-range values following approval by the PI or delegate.
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 |
|---|---|---|
| HSK56630Orally administered tablets of HSK56630 | Drug | Drug |
| PlaceboOrally administered tablets of placebo | Drug | Placebo |
Primary outcome
To evaluate the safety and tolerability of single ascending doses of HSK56630 in healthy adult subjects
Time frame: 8 days
Frequency of adverse events as assessed by the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 6.0
6 secondary outcomes
To evaluate the pharmacokinetics (PK) of a single dose of HSK56630 in healthy participants.
Time frame: 8 days
To evaluate the pharmacokinetics (PK) of a single dose of HSK56630 in healthy participants.
Time frame: 8 days
To evaluate the pharmacokinetics (PK) of a single dose of HSK56630 in healthy participants.
Time frame: 8 days
To evaluate the pharmacokinetics (PK) of a single dose of HSK56630 in healthy participants.
Time frame: 8 days
To evaluate the pharmacokinetics (PK) of a single dose of HSK56630 in healthy participants.
Time frame: 8 days
To evaluate the pharmacodynamics (PD) of HSK56630.
Time frame: 8 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 24 Jun 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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 HSK56630 in people with Healthy Volunteer, run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in Australia.
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 6 inclusion and 20 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 24 Jun 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 Australia. 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 Chen Meixia (028-67258779, chenmeixia@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of single ascending doses of HSK56630 in healthy adult subjects (time frame: 8 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 24 Jun 2026.