CompletedPhase 1

A Sequential Single and Multiple Ascending Dose (SAD/MAD) Study of SK10 Powders in Healthy Adult Subjects

United States24 participantsStarted 2023-08-01

Plain-language summary

The purpose of this study is to assess the safety and tolerability of orally administered SK10 powders in healthy adult subjects at three dose levels, following single and multiple doses.

Who can participate

Age range

18 Years – 55 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: * Subject must have negative test results for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), anti-hepatitis C virus antibodies (anti-HCV) and anti-human immunodeficiency virus (HIV) antibodies at Screening Visit * Body weight ≥ 50.0 kg for males, or ≥ 45.0 kg for females, and body mass index within the range of 18.0-28.0 kg/m2 (inclusive). * A male subject must agree to use together with his female partner/ spouse a highly effective contraception form of birth control in combination with a barrier method throughout the clinical study period and until 90 days after the last dose of IMP. Male subjects must also refrain from donating sperm from the time of informed consent until 90 days after the last dose of IMP. * A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: * Non-childbearing potential (OR) * A woman of childbearing potential (WOCBP) who agrees to use highly effective methods of birth control in combination with a barrier method at least 3 months prior to the Screening Visit until 30 days after the last dose of IMP. * WOCBP must agree not to donate ova from the time of informed consent until 30 days after the last dose of IMP. * WOCBP must have a negative serum pregnancy test at the Screening Visit. Exclusion Criteria: * History or presence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal…

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

Number of participants with Treatment-Emergent Adverse Events (TEAEs)

Timeframe: From screening (Day -28) up to follow-up [FU] (Days 24±2)

Number of participants with clinically relevant changes from baseline electrocardiogram (ECG) parameters

Timeframe: From screening (Day -28), Days -1,1,3, 11,19 up to FU (Days 24±2)

Trial details

NCT IDNCT06026397

SponsorGuangzhou Zhiyi Biotechnology Co., Ltd.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-11

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