Diarrhea Caused by Drug (Disorder)Phase 1NCT06610487
A Study of FT1 in Healthy Adult Volunteers
A Phase 1 study testing FT1 in people with Diarrhea Caused by Drug (Disorder), run by Chongqing Peg-Bio Biopharm Co., Ltd. at 1 site in China.
Trial summary
The main aim of this clinical trial is to assess the safety of FT1 in participants aged 18 to 45 years. The main questions it aims to answer are: Is FT1 safe in healthy adults? Researchers will compare FT1 to a placebo (a look-alike substance that contains no drug) to see if FT1 is safe and active in human. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea Caused by Drug (Disorder)
- What is being tested?
- FT1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2024to 8 Aug 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy male or female subjects aged 18 to 45 years (inclusive);
- Male subjects weighing ≥ 50.0kg, female subjects weighing ≥ 45kg; body mass index (BMI) in the range of 19.0-26.0 kg/m^2 (inclusive);
- Voluntarily participate and sign the informed consent form;
- Be able to complete the trial in accordance with the protocol.
Who cannot join
- History of allergic diseases (including but not limited to asthma, urticaria, allergic rhinitis), or a history of drug allergies, or a history of allergies to the ingredients of the investigational drug;
- Abnormal results of vital signs, physical examination, 12 lead electrocardiogram examination, and laboratory tests (including blood routine, urine routine, blood biochemistry, coagulation function, thyroid function) during the screening period with clinically significance determined by the researcher;
- History or experiencing diseases with abnormal clinical manifestations, including but not limited to neurological/psychiatric, respiratory, cardiovascular, digestive, blood and lymphatic, urinary, endocrine, immune system diseases, or any other diseases or physiological conditions that may interfere with test results;
- With intestinal polyp disease or have undergone intestinal polyp surgery within 6 months before screening;
- Any positive results of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum (TP) antibody test;
- Positive urine test results for drug abuse (including morphine, methamphetamine, ketamine, cocaine, methylenedioxymethamphetamine, tetrahydrocannabinolic acid);
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- History of drug use or drug abuse (including the use of prohibited substances for medical use and controlled drugs);
- History of critical surgery within 3 months before screening or plan to undergo surgery during the trial, as well as a history of surgery that may affect drug absorption, distribution, metabolism and excretion;
- Participated in any clinical trial as a subject within 3 months before screening;
- Have donated blood or lost more than 400 mL of blood/plasma within 3 months before screening (except for physiological blood loss in women);
- Alcoholics (i.e. males drinking more than 28 standard units of alcohol per week and females drinking more than 21 standard units of alcohol per week, with 1 standard unit containing 14g of alcohol, such as 360mL beer or 45mL of 40% spirits or 150mL wine) or those who have frequently consumed alcohol within the previous 6 months (i.e. drinking more than 14 standard units of alcohol per week), or those who cannot abstain from alcohol during the trial, or those who have a positive alcohol breath test;
- Took any prescription or over-the-counter drugs, as well as any functional vitamins or herbal products within 14 days before screening;
- Have a long-term history of excessive consumption of tea, coffee or caffeinated beverages (more than 8 cups per day, 1 cup = 250mL)
- Smoked more than 5 cigarettes per day within 6 months before screening;
- Cannot guarantee to refrain from strenuous exercise, smoking and special diet (including grapefruit, chocolate, tea, cola, or any food or beverage containing caffeine, alcoholic beverages or other food or beverage that affects drug absorption, distribution, metabolism and excretion) from 48 hours before medication to the last blood collection;
- Pregnant or lactating women, or female subjects who have had unprotected sex in the past two weeks, or female subjects with positive pregnancy test; subjects (or their partners) who have fertility plans or sperm/egg donations during the entire trial period and within 6 months after the last medication, and are unwilling to take one or more contraceptive measures during the trial and within 6 months after the last medication;
- Cannot tolerate venous puncture or have difficulty in venous blood collection;
- History of needle phobia or blood phobia or known severe bleeding tendency;
- Have special dietary requirements and cannot follow a uniform diet;
- The investigator believes the subject is unsuitable for participating in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
Bishan Hospital of Chongqing
Chongqing, Chongqing Municipality, 402760
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of FT1 in Healthy Adult Volunteers
The main aim of this clinical trial is to assess the safety of FT1 in participants aged 18 to 45 years. The main questions it aims to answer are:
- Is FT1 safe in healthy adults? Researchers will compare FT1 to a placebo (a look-alike substance that contains no drug) to see if FT1 is safe and active in human.
Participants will
- Receive one subcutaneous injection or multiple injections of FT1 or placebo according to weight.
- Visit the clinic for assessment.
Read the detailed description
This study is a first-in-human study, which is a single-center, randomized, placebo-controlled, double-blind, dose escalation clinical study, aiming to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of FT1 in healthy adult volunteers.
The trial is divided into 2 parts, single-dose part and multiple-dose part. In multiple-dose part, participants will receive once weekly subcutaneous injection of FT1 for 3 weeks.
- Conditions
- Diarrhea Caused by Drug (Disorder)
- Being tested
- FT1, Placebo
- Keywords
- Chemotherapy induced diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT1Drug
Six dose levels will be evaluated in single-dose part, and three dose levels in multiple-dose part.
PlaceboDrug
Placebo will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Single-dose FT1 | Experimental | A single dose of FT1 will be administered, subcutaneous injection Receives: Drug: FT1 |
| Single-dose FT1 Placebo | Placebo comparator | A single dose of FT1 Placebo will be administered, subcutaneous injection Receives: Drug: Placebo |
| Multiple-dose FT1 | Experimental | FT1 will be administered once weekly for 3 weeks, subcutaneous injection Receives: Drug: FT1 |
| Multiple-dose FT1 Placebo | Placebo comparator | FT1 Placebo will be administered once weekly for 3 weeks, subcutaneous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-related Adverse Events
To evaluate the adverse events as characterized by type, frequency, severity as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, timing, seriousness, and relationship to study therapy after administration.
Measured: up to 29 days in single-dose part, and up to 43 days in multiple-dose part
Secondary outcomes (4)
The Area Under the Curve from dosing to the time of the last measured concentration (AUC0-t)
Pharmacokinetic parameter
Measured: up to 29 days in single-dose part, and up to 43 days in multiple-dose part
Maximum plasma concentration (Cmax)
Pharmacokinetic parameter
Measured: up to 29 days in single-dose part, and up to 43 days in multiple-dose part
The half-life (t1/2)
Pharmacokinetic parameter
Measured: up to 29 days in single-dose part, and up to 43 days in multiple-dose part
Anti-drug Antibody
Immunogenicity of FT1
Measured: up to 29 days in single-dose part, and up to 43 days in multiple-dose part
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start20 Aug 2024
- Primary completion8 Aug 2025
- Study completion8 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea Caused by Drug (Disorder)Studies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610487
- Sponsor's protocol ID
- CQPJ-FT1-001
- Status last verified
- Feb 2026
- First submitted
- 20 Sep 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of FT1 in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06610487
- Acronym / sponsor ID
- CQPJ-FT1-001
- Conditions
- Diarrhea Caused by Drug (Disorder)
- Keywords
- Chemotherapy induced diarrhea
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- 8 Aug 2025 (actual)
- First posted
- 24 Sep 2024 (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 main aim of this clinical trial is to assess the safety of FT1 in participants aged 18 to 45 years. The main questions it aims to answer are:
- Is FT1 safe in healthy adults? Researchers will compare FT1 to a placebo (a look-alike substance that contains no drug) to see if FT1 is safe and active in human.
Participants will
- Receive one subcutaneous injection or multiple injections of FT1 or placebo according to weight.
- Visit the clinic for assessment.
Detailed description
This study is a first-in-human study, which is a single-center, randomized, placebo-controlled, double-blind, dose escalation clinical study, aiming to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of FT1 in healthy adult volunteers.
The trial is divided into 2 parts, single-dose part and multiple-dose part. In multiple-dose part, participants will receive once weekly subcutaneous injection of FT1 for 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single-dose FT1 | Experimental | Drug: FT1A single dose of FT1 will be administered, subcutaneous injection |
| Single-dose FT1 Placebo | Placebo comparator | Drug: PlaceboA single dose of FT1 Placebo will be administered, subcutaneous injection |
| Multiple-dose FT1 | Experimental | Drug: FT1FT1 will be administered once weekly for 3 weeks, subcutaneous injection |
| Multiple-dose FT1 Placebo | Placebo comparator | Drug: PlaceboFT1 Placebo will be administered once weekly for 3 weeks, subcutaneous injection |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy male or female subjects aged 18 to 45 years (inclusive);
- Male subjects weighing ≥ 50.0kg, female subjects weighing ≥ 45kg; body mass index (BMI) in the range of 19.0-26.0 kg/m^2 (inclusive);
- Voluntarily participate and sign the informed consent form;
- Be able to complete the trial in accordance with the protocol.
Key exclusion criteria (20 listed)
- History of allergic diseases (including but not limited to asthma, urticaria, allergic rhinitis), or a history of drug allergies, or a history of allergies to the ingredients of the investigational drug;
- Abnormal results of vital signs, physical examination, 12 lead electrocardiogram examination, and laboratory tests (including blood routine, urine routine, blood biochemistry, coagulation function, thyroid function) during the screening period with clinically significance determined by the researcher;
- History or experiencing diseases with abnormal clinical manifestations, including but not limited to neurological/psychiatric, respiratory, cardiovascular, digestive, blood and lymphatic, urinary, endocrine, immune system diseases, or any other diseases or physiological conditions that may interfere with test results;
- With intestinal polyp disease or have undergone intestinal polyp surgery within 6 months before screening;
- Any positive results of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum (TP) antibody test;
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 |
|---|---|---|
| FT1Six dose levels will be evaluated in single-dose part, and three dose levels in multiple-dose part. | Drug | Multiple-dose FT1, Single-dose FT1 |
| PlaceboPlacebo will be administered. | Drug | Multiple-dose FT1 Placebo, Single-dose FT1 Placebo |
Primary outcome
Treatment-related Adverse Events
Time frame: up to 29 days in single-dose part, and up to 43 days in multiple-dose part
To evaluate the adverse events as characterized by type, frequency, severity as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, timing, seriousness, and relationship to study therapy after administration.
4 secondary outcomes
The Area Under the Curve from dosing to the time of the last measured concentration (AUC0-t)
Time frame: up to 29 days in single-dose part, and up to 43 days in multiple-dose part
Maximum plasma concentration (Cmax)
Time frame: up to 29 days in single-dose part, and up to 43 days in multiple-dose part
The half-life (t1/2)
Time frame: up to 29 days in single-dose part, and up to 43 days in multiple-dose part
Anti-drug Antibody
Time frame: up to 29 days in single-dose part, and up to 43 days in multiple-dose part
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 2 Mar 2026.
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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 FT1 in people with Diarrhea Caused by Drug (Disorder), run by Chongqing Peg-Bio Biopharm Co., Ltd. at 1 site in China.
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 4 inclusion and 20 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 2 Mar 2026. 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 China. 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. Some participants in this study may receive a placebo. 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?
Treatment-related Adverse Events (time frame: up to 29 days in single-dose part, and up to 43 days in multiple-dose part). 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 2 Mar 2026.