Chemotherapy-induced DiarrheaPhase 1NCT06026397
A Sequential Single and Multiple Ascending Dose (SAD/MAD) Study of SK10 Powders in Healthy Adult Subjects
A Phase 1 study testing SK10 in people with Chemotherapy-induced Diarrhea, run by Guangzhou Zhiyi Biotechnology Co., Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy-induced Diarrhea
- What is being tested?
- SK10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 11 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- History or presence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- History/current symptom related to gastrointestinal abnormalities within 2 weeks before the first dose.
- Subject is a pregnant or lactating women.
- Known or suspected hypersensitivity to the IMP or excipients of the IMP.
- Subjects with lactose intolerance/allergy.
- Known or ongoing psychiatric disorders, or active neuropsychiatric disease deemed clinically significant in the opinion of the investigator.
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- Subject has used over-the-counter or other oral medications (including vitamins), prescription medications, or herbal remedies within 14 days before dosing.
- Subject has had major surgery within 3 months before Screening, or plan to perform surgery during the study.
- Subject experiences an acute medical condition or uses concomitant medication during the Screening period.
- Subject has been treated with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of the IMP.
- Subject has taken probiotic foods and/or drinks and/or health products within 1 week before the first dose.
- History of alcohol and/or illicit drug abuse within 2 years before Screening.
- Subject has positive urine drug or alcohol test at the Screening Visit or Admission.
- No more than 5 cigarettes are allowed from screening to admission, and smoking is not allowed from admission until after the last follow-up visit.
- Subject has donated or lost ≥ 400 mL of whole blood within 3 months or donated plasma within 14 days before Screening.
- Subjects has received vaccination within 14 days before the first dose or vaccination planned during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Early Phase Clinical Unit (EPCU) - PAREXEL
Glendale, California, 91206
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Sequential Dose-escalation Clinical Study to Evaluate the Safety and Tolerability of SK10 Powders (Inactivated Bacteroides Fragilis) in Healthy Adult Subjects
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.
Read the detailed description
This is a first-in-human, Phase 1, randomized, double-blind, placebo-controlled, sequential SAD and MAD study to assess the safety and tolerability of orally administered SK10 powders in healthy adult subjects.
This is a dose escalation study with three sequential cohorts planned testing at 3 dose levels.
A total of 24 subjects are planned to be enrolled into 3 cohorts (Cohorts 1, 2 and 3). Within each cohort, eligible subjects will be randomized to receive SK10 or placebo in a 3:1 ratio. The treatment duration includes a single dose administration on Day 1 and 14-day repeat doses administration from Day 4 to Day 17.
The study consists of:
- Screening Period (28 days [Day -28 to Day -1])
- Treatment Period (Day -1 to Day 19)
- Follow-up Visit (Day 24).
The study duration will be approximately up to 52 days, conducted at a single center.
- Conditions
- Chemotherapy-induced Diarrhea
- Being tested
- SK10, Placebo
- Keywords
- Single ascending dose, Multiple ascending dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SK10Drug
Participants will be randomized to receive oral suspension of SK10 powder, includes SAD on Day 1 and 14-days MAD from Day 4 to Day 17.
PlaceboDrug
Participants will be randomized to receive oral suspension of placebo, includes SAD on Day 1 and 14-days MAD from Day 4 to Day 17.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Participants will receive dose A of SK10 (n=6) or placebo (n=2) Receives: Drug: SK10; Drug: Placebo |
| Cohort 2 | Experimental | Participants will receive dose B of SK10 (n=6) or placebo (n=2) Receives: Drug: SK10; Drug: Placebo |
| Cohort 3 | Experimental | Participants will receive dose C of SK10 (n=6) or placebo (n=2) Receives: Drug: SK10; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Number of participants with TEAEs to evaluate the safety and tolerability of SK10 in healthy adult subjects
Measured: From screening (Day -28) up to follow-up [FU] (Days 24±2)
Number of participants with clinically relevant changes from baseline electrocardiogram (ECG) parameters
Number of participants with clinically relevant changes from baseline ECG parameters to evaluate the safety and tolerability of SK10 in healthy adult subjects
Measured: From screening (Day -28), Days -1,1,3, 11,19 up to FU (Days 24±2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start1 Aug 2023
- Primary completion11 Feb 2024
- Study completion11 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-induced DiarrheaStudies of the same condition, open and under way.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Zhiyi Biotechnology Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026397
- Sponsor's protocol ID
- SK10-101
- Status last verified
- Feb 2024
- First submitted
- 30 Aug 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Sequential Dose-escalation Clinical Study to Evaluate the Safety and Tolerability of SK10 Powders (Inactivated Bacteroides Fragilis) in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06026397
- Acronym / sponsor ID
- SK10-101
- Conditions
- Chemotherapy-induced Diarrhea
- Keywords
- Single ascending dose, Multiple ascending dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Guangzhou Zhiyi Biotechnology Co., Ltd.University, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 11 Feb 2024 (actual)
- Study completion
- 11 Feb 2024 (actual)
- First posted
- 7 Sep 2023 (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.
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.
Detailed description
This is a first-in-human, Phase 1, randomized, double-blind, placebo-controlled, sequential SAD and MAD study to assess the safety and tolerability of orally administered SK10 powders in healthy adult subjects.
This is a dose escalation study with three sequential cohorts planned testing at 3 dose levels.
A total of 24 subjects are planned to be enrolled into 3 cohorts (Cohorts 1, 2 and 3). Within each cohort, eligible subjects will be randomized to receive SK10 or placebo in a 3:1 ratio. The treatment duration includes a single dose administration on Day 1 and 14-day repeat doses administration from Day 4 to Day 17.
The study consists of:
- Screening Period (28 days [Day -28 to Day -1])
- Treatment Period (Day -1 to Day 19)
- Follow-up Visit (Day 24).
The study duration will be approximately up to 52 days, conducted at a single center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: SK10, Drug: PlaceboParticipants will receive dose A of SK10 (n=6) or placebo (n=2) |
| Cohort 2 | Experimental | Drug: SK10, Drug: PlaceboParticipants will receive dose B of SK10 (n=6) or placebo (n=2) |
| Cohort 3 | Experimental | Drug: SK10, Drug: PlaceboParticipants will receive dose C of SK10 (n=6) or placebo (n=2) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (16 listed)
- History or presence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- History/current symptom related to gastrointestinal abnormalities within 2 weeks before the first dose.
- Subject is a pregnant or lactating women.
- Known or suspected hypersensitivity to the IMP or excipients of the IMP.
- Subjects with lactose intolerance/allergy.
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 |
|---|---|---|
| SK10Participants will be randomized to receive oral suspension of SK10 powder, includes SAD on Day 1 and 14-days MAD from Day 4 to Day 17. | Drug | Cohort 1, Cohort 2, Cohort 3 |
| PlaceboParticipants will be randomized to receive oral suspension of placebo, includes SAD on Day 1 and 14-days MAD from Day 4 to Day 17. | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: From screening (Day -28) up to follow-up [FU] (Days 24±2)
Number of participants with TEAEs to evaluate the safety and tolerability of SK10 in healthy adult subjects
Number of participants with clinically relevant changes from baseline electrocardiogram (ECG) parameters
Time frame: From screening (Day -28), Days -1,1,3, 11,19 up to FU (Days 24±2)
Number of participants with clinically relevant changes from baseline ECG parameters to evaluate the safety and tolerability of SK10 in healthy adult subjects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 SK10 in people with Chemotherapy-induced Diarrhea, run by Guangzhou Zhiyi Biotechnology Co., Ltd. at 1 site in United States.
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 8 inclusion and 16 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: finished, as of the sponsor's last update on 20 Feb 2024. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Treatment-Emergent Adverse Events (TEAEs) (time frame: From screening (Day -28) up to follow-up [FU] (Days 24±2)). The study lists 2 primary outcomes in all. 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 20 Feb 2024.