Health TrialsbyHealthPanel

First-in-human Study of HSK56630 in Healthy Subjects

ConditionHealthy Volunteer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHaisco Pharmaceutical Group Co., Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • HSK56630

    Drug

    Orally administered tablets of HSK56630

  • Placebo

    Drug

    Orally administered tablets of placebo

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: DrugExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
8 days

Secondary outcomes

1

To evaluate the pharmacokinetics (PK) of a single dose of HSK56630 in healthy participants.

Peak plasma Concentration (Cmax)

Time frame
8 days
2

To evaluate the pharmacokinetics (PK) of a single dose of HSK56630 in healthy participants.

Area under the drug concentration-time curve (AUC)

Time frame
8 days
3

To evaluate the pharmacokinetics (PK) of a single dose of HSK56630 in healthy participants.

Apparent terminal half-life (t½)

Time frame
8 days
4

To evaluate the pharmacokinetics (PK) of a single dose of HSK56630 in healthy participants.

Apparent total plasma clearance of drug (CL/F)

Time frame
8 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haisco Pharmaceutical Group Co., Ltd.

Lead sponsor

Veritus Research Pty Ltd

Collaborator

Source ClinicalTrials.gov
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