First-in-human Study of HSK56630 in Healthy Subjects (NCT07580794) | Clinical Trial Compass
RecruitingPhase 1
First-in-human Study of HSK56630 in Healthy Subjects
Australia40 participantsStarted 2026-06-17
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the safety and tolerability of single ascending doses of HSK56630 in healthy adult subjects
. 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.
. 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.