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SK10 Safety Study in Healthy Adults

Phase 1

Waitlist Available

Research Sponsored by Guangzhou Zhiyi Biotechnology Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening (day -28), days -1,1,3, 11,19 up to fu (days 24±2)

Awards & highlights

Study Summary

This trial tests the safety of a drug given orally to adults at 3 different levels, both once and multiple times.

Who is the study for?

Healthy adults who can join this trial must not have hepatitis, HIV, or be pregnant. They should weigh enough and have a BMI of 18-28 kg/m2. Men must use birth control with their partners and avoid donating sperm for 90 days post-trial. Women need to use birth control too and cannot donate eggs for 30 days after the trial.Check my eligibility

What is being tested?

The study is testing SK10 powders against a placebo in healthy people to see if they're safe at different doses when taken once or multiple times. Participants will receive either SK10 or an inactive substance without knowing which one.See study design

What are the potential side effects?

While specific side effects are not listed, the study aims to identify any adverse reactions from taking SK10 powder orally at various single and repeated doses compared to a placebo.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening (day -28), days -1,1,3, 11,19 up to fu (days 24±2)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening (day -28), days -1,1,3, 11,19 up to fu (days 24±2)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening (day -28), days -1,1,3, 11,19 up to fu (days 24±2) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3Experimental Treatment2 Interventions

Participants will receive dose C of SK10 (n=6) or placebo (n=2)

Group II: Cohort 2Experimental Treatment2 Interventions

Participants will receive dose B of SK10 (n=6) or placebo (n=2)

Group III: Cohort 1Experimental Treatment2 Interventions

Participants will receive dose A of SK10 (n=6) or placebo (n=2)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SK10

2023

Completed Phase 1

~30

Placebo

1995

Completed Phase 3

~2670

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Guangzhou Zhiyi Biotechnology Co., Ltd.Lead Sponsor

1 Previous Clinical Trials

1,298 Total Patients Enrolled

1 Trials studying Diarrhea

1,298 Patients Enrolled for Diarrhea

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age limit for the participants enrolled in this study?

"This trial is open to individuals who are within the 18-55 age bracket."

Answered by AI

What level of safety can be expected from Cohort 1 participants?

"Our experts rate Cohort 1's safety as a '1' since this is an exploratory Phase 1 trial, in which there are limited findings regarding its efficacy and safety."

Answered by AI

Who has been identified as a potential participant for this experiment?

"To take part in this trial, individuals must have episodes of diarrhea and be aged between 18-55. The researchers are looking for approximately 24 participants to join the study."

Answered by AI

Are there any available positions for participants in this research study?

"According to the information listed on clinicaltrials.gov, this experiment is still actively seeking participants. The initial posting for it was published in late August of 2023 with recent updates occurring a few days later."

Answered by AI

How many participants are being monitored in this clinical trial?

"Affirmative. On clinicaltrials.gov, there is evidence that this medical experiment, which was first published on August 22nd 2023, is actively seeking participants. Exactly 24 people must be enlisted from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Sequential Single and Multiple Ascending Dose (SAD/MAD) Study of SK10 Powders in Healthy Adult Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06026397.