Inflammatory Bowel Disease(IBD)Phase 1NCT07911982
Safety, Tolerability and Pharmacokinetics of ICP-B161 in Healthy Adults Volunteers
A Phase 1 study testing ICP-B161 (SC or IV) in people with Inflammatory Bowel Disease(IBD), run by Beijing InnoCare Pharma Tech Co., Ltd..
Trial summary
This is a randomized, double-blind, placebo-controlled, ascending dose study. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part A) followed by a multiple ascending dose (MAD) part (Part B). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease(IBD)
- What is being tested?
- ICP-B161 (SC or IV)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 volunteers will be included in Part A or Part B of the study if they satisfy all the following criteria:
- Must have given written informed consent before any study-related activities are carried out and must be able to communicate well with the researchers, and complete the study according to the study regulations；
- Body mass index (BMI) ≥ 18.0 and ≤ 26.0 kg/m2, and male participants weighing no less than 50 kg and female participants no less than 45 kg;
- Medically healthy without clinically significant abnormalities at screening and pre-dose on Day 1, including: vital signs, physical exams, and ECG results, as well as chest image and abdominal ultrasounds, should be within the normal reference range for healthy individuals or slightly outside but still acceptable, with no clinical significance according to the researchers' judgment.
- Medically healthy without clinically significant findings in serum chemistry, hematology, coagulation and urinalysis tests as judged by the investigator.
- Male participants and/or female participants who are infertile should be between 18-45 years old at the time of signing the informed consent form (inclusive).
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- Infertile female participants (who are physiologically unable to get pregnant, including postmenopausal or surgically sterile women) must meet at least one of the following:
- Surgically sterile women are defined as those who have a full hysterectomy, bilateral tubal ligation, or bilateral oophorectomy at least 6 weeks before receiving the study, with relevant clinical records.
- Postmenopausal women are defined as women who have not any menstrual bleeding (including periods, irregular bleeding, spotting, etc.) for at least 12 months and have no other cause for amenorrhea (e.g., hormonal contraception, hormone replacement therapy, prior chemotherapy), confirmed with serum follicle-stimulating hormone (FSH) >40 MIU/mL and estradiol <40 pg/mL (<140 pmol/L) to verify postmenopausal status.
- Male participants and their partners must agree to follow contraceptive guidance throughout the study period, and male participants must not donate sperm during this period.
Who cannot join
- Healthy volunteers will be excluded from Part A or Part B of the study if there is evidence of any of the following at screening, Day -1 or pre-dose on Day 1:
- Unable to comply with the requirements of the protocol.
- History or presence of clinical significance, such as hematologic, kidney, endocrine, lung, gastrointestinal, cardiovascular, liver, mental disorders, or nervous system diseases, or allergic diseases (including drug allergies, such as a history of heparin allergy or heparin-induced thrombocytopenia, but not including untreated, asymptomatic seasonal allergies).
- An acute illness within 14 days before administration (such as nausea, vomiting, fever, or diarrhea).
- Currently infection, or experienced a severe infection within 6 months before or during administration (such as infections requiring antibiotic, antifungal, antiparasitic or antiviral medications), or having chronic or recurrent infectious diseases.
- Trial participants and/or their first-degree relatives have genetic immunodeficiency.
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- Experienced severe trauma or major surgery within 3 months before administration.
- History of tuberculosis; signs or symptoms of active tuberculosis as judged by the investigator during screening (such as fever, cough, night sweats, and weight loss); chest imaging (e.g., chest X-ray, chest CT scan) at screening or any time within the 6 months prior showing active pulmonary tuberculosis; contact with patients with open tuberculosis within the last 6 months; positive tuberculosis test (QuantiFERON®-TB or T-SPOT.TB test) during screening - those who test positive may not need a chest X-ray.
- Positive drug test results;
- Heavy drinkers: Women who usually drink more than 7 drinks per week or men more than 14 drinks per week in the 6 months before screening (1 drink = 150 ml wine, 360 ml beer, or 45 ml spirits) or anyone who tests positive on a breath alcohol test prior to the first study drug administration.
- Donated more than 500 ml of blood (not including plasma) within 56 days prior to the first study drug administration, or plan to donate blood or blood components during the study or within 1 month after the study.
- Used other investigational drugs within the following time limits prior to the first study drug administration:
- Small molecules: 5 half-lives or 30 days (whichever is longer);
- Biologics: 5 half-lives or 90 days (whichever is longer);
- Other drugs (including those with insufficient information): 5 half-lives or 90 days (whichever is longer).
- Used the same type of antibody drug within 7 half-lives prior to the first study drug administration.
- Use of systemic glucocorticoids, immunosuppressants or modulators, hormone replacement therapy, or any other treatments that could affect drug absorption, distribution, metabolism, or excretion within 30 days before the first dose, or use of any other prescription drugs, over-the-counter drugs, herbal medicines, or dietary supplements (including vitamins and health products) within 14 days prior to the first study drug administration.
- Anyone testing positive for syphilis-specific antibodies, hepatitis C antibodies (HCV-Ab), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or human immunodeficiency virus serology antibody (HIV-Ab) during the screening period.
- Vaccination with live virus vaccines, attenuated live vaccines, or any vaccines containing live virus components within 6 weeks before the first dose, during the planned study period, or within 8 weeks after the study ends.
- Any history of severe or recurrent suicidal behavior, or during the screening period (looking back 12 months) or at baseline, having answered "yes" to suicidal ideation questions 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS), or any suicidal behavior in the past 5 years, meaning "yes" to any question on C-SSRS regarding suicidal behavior in the past 5 years.
- Any other situations that the investigator judges as unsuitable for participating in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-ascending-dose Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-B161 in Healthy Participants
This is a randomized, double-blind, placebo-controlled, ascending dose study. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part A) followed by a multiple ascending dose (MAD) part (Part B).
The decision to escalate between dose levels and proceed to Part B will be based upon review of blinded available safety data by a Safety Review Committee.
- Conditions
- Inflammatory Bowel Disease(IBD)
- Being tested
- ICP-B161 (SC or IV), Placebo (SC or IV)
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-B161 (SC or IV)Drug
Dose escalation in Part A will be conducted in 3 Cohorts (Cohorts 1 to 3). Eight participants will be enrolled in each cohort and randomized to receive either ICP-B161 or placebo (ratio 5:1). ICP-B161 will be administered to Cohort 1 participants at the starting dose of 150 mg sc and increased in each new group. Three nominal dose levels in the range of 150 mg sc to 900 mg iv have been selected for evaluation in Part A. The starting dose level in Part B will be determined by the SRC based on safety and tolerability data obtained in Part A. The dose level and cohorts will only be evaluated in Part B if determined to be safe and tolerable in Part A. Eight participants will be enrolled in each cohort and will be randomized to receive a single dose of either ICP-B161 or placebo (ratio 3:1), day1 and day29.
Placebo (SC or IV)Drug
Dose escalation in Part A will be conducted in 3 Cohorts (Cohorts 1 to 3). Eight participants will be enrolled in each cohort and randomized to receive either ICP-B161 or placebo (ratio 5:1). ICP-B161 will be administered to Cohort 1 participants at the starting dose of 150 mg sc and increased in each new group. Three nominal dose levels in the range of 150 mg sc to 900 mg iv have been selected for evaluation in Part A. The starting dose level in Part B will be determined by the SRC based on safety and tolerability data obtained in Part A. The dose level and cohorts will only be evaluated in Part B if determined to be safe and tolerable in Part A. Eight participants will be enrolled in each cohort and will be randomized to receive a single dose of either ICP-B161 or placebo (ratio 3:1), day1 and day29.
| Study group | Role | What they receive |
|---|---|---|
| ICP-B161 | Experimental | Not described Receives: Drug: ICP-B161 (SC or IV) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo (SC or IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of abnormal vital signs, physical examination findings and abnormal ECG results
Specific assessments to evaluate treatment safety and tolerability include the following: vital signs, physical examinations, and 12-lead ECG
Measured: Part A:301 days Part B:321 days
Specific assessments to evaluate the incidence, severity and relationship of adverse events (AEs)
Specific assessments to evaluate treatment safety and tolerability include the following: the incidence, severity, and relationship of AEs
Measured: Part A:301 days Part B:321 days
Incidence of abnormal clinical laboratory test results
Specific assessments to evaluate treatment safety and tolerability include the following: change from baseline in clinical laboratory parameters (ie, hematology, serum chemistry, coagulation, and urinalysis parameters)
Measured: Part A:301 days Part B:321 days
Secondary outcomes (7)
The peak concentration (Cmax) of ICP-B161 after single and multiple doses
Specific assessments to evaluate the peak concentration (Cmax) of ICP-B161
Measured: Part A:301 days Part B:321 days
The time to peak (Tmax) of ICP-B161 after single and multiple doses
Specific assessments to evaluate the time to peak (Tmax) of ICP-B161
Measured: Part A:301 days Part B:321 days
The half-life (t1/2) of ICP-B161 after single and multiple doses
Specific assessments to evaluate the half-life (t1/2) of ICP-B161
Measured: Part A:301 days Part B:321 days
The area under the blood concentration-time curve (AUC0-∞ and AUC0-t) of ICP-B161 after single and multiple doses
Specific assessments to evaluate the area under the blood concentration-time curve (AUC0-∞ and AUC0-t) of ICP-B161
Measured: Part A:301 days Part B:321 days
The occurrence rate of antibody of anti-ICP-B161 antibodies
Specific assessments to evaluate the occurrence rate of anti-ICP-B161 antibodies
Measured: Part A:301 days Part B:321 days
The antibody titer of anti-ICP-B161 antibodies
Specific assessments to evaluate the antibody titer of anti-ICP-B161 antibodies
Measured: Part A:301 days Part B:321 days
The occurrence rate of neutralizing antibodies of anti-ICP-B161 antibodies
Specific assessments to evaluate the occurrence rate of neutralizing antibodies of anti-ICP-B161 antibodies
Measured: Part A:301 days Part B:321 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease(IBD)Studies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911982
- Sponsor's protocol ID
- ICP-CL-02001
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo-controlled, Single- and Multiple-ascending-dose Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-B161 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07911982
- Acronym / sponsor ID
- ICP-CL-02001
- Conditions
- Inflammatory Bowel Disease(IBD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 3 Nov 2026 (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.
This is a randomized, double-blind, placebo-controlled, ascending dose study. The study will be conducted in 2 parts: a single ascending dose (SAD) part (Part A) followed by a multiple ascending dose (MAD) part (Part B).
The decision to escalate between dose levels and proceed to Part B will be based upon review of blinded available safety data by a Safety Review Committee.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICP-B161 | Experimental | Drug: ICP-B161 (SC or IV) |
| Placebo | Placebo comparator | Drug: Placebo (SC or IV) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Healthy volunteers will be included in Part A or Part B of the study if they satisfy all the following criteria:
Key exclusion criteria (21 listed)
- Healthy volunteers will be excluded from Part A or Part B of the study if there is evidence of any of the following at screening, Day -1 or pre-dose on Day 1:
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 |
|---|---|---|
| ICP-B161 (SC or IV)Dose escalation in Part A will be conducted in 3 Cohorts (Cohorts 1 to 3). Eight participants will be enrolled in each cohort and randomized to receive either ICP-B161 or placebo (ratio 5:1). ICP-B161 will be administered to Cohort 1 participants at the starting dose of 150 mg sc and increased in each new group. Three nominal dose levels in the range of 150 mg sc to 900 mg iv have been selected for evaluation in Part A. The starting dose level in Part B will be determined by the SRC based on safety and tolerability data obtained in Part A. The dose level and cohorts will only be evaluated in Part B if determined to be safe and tolerable in Part A. Eight participants will be enrolled in each cohort and will be randomized to receive a single dose of either ICP-B161 or placebo (ratio 3:1), day1 and day29. | Drug | ICP-B161 |
| Placebo (SC or IV)Dose escalation in Part A will be conducted in 3 Cohorts (Cohorts 1 to 3). Eight participants will be enrolled in each cohort and randomized to receive either ICP-B161 or placebo (ratio 5:1). ICP-B161 will be administered to Cohort 1 participants at the starting dose of 150 mg sc and increased in each new group. Three nominal dose levels in the range of 150 mg sc to 900 mg iv have been selected for evaluation in Part A. The starting dose level in Part B will be determined by the SRC based on safety and tolerability data obtained in Part A. The dose level and cohorts will only be evaluated in Part B if determined to be safe and tolerable in Part A. Eight participants will be enrolled in each cohort and will be randomized to receive a single dose of either ICP-B161 or placebo (ratio 3:1), day1 and day29. | Drug | Placebo |
Primary outcome
Incidence of abnormal vital signs, physical examination findings and abnormal ECG results
Time frame: Part A:301 days Part B:321 days
Specific assessments to evaluate treatment safety and tolerability include the following: vital signs, physical examinations, and 12-lead ECG
Specific assessments to evaluate the incidence, severity and relationship of adverse events (AEs)
Time frame: Part A:301 days Part B:321 days
Specific assessments to evaluate treatment safety and tolerability include the following: the incidence, severity, and relationship of AEs
Incidence of abnormal clinical laboratory test results
Time frame: Part A:301 days Part B:321 days
Specific assessments to evaluate treatment safety and tolerability include the following: change from baseline in clinical laboratory parameters (ie, hematology, serum chemistry, coagulation, and urinalysis parameters)
7 secondary outcomes
The peak concentration (Cmax) of ICP-B161 after single and multiple doses
Time frame: Part A:301 days Part B:321 days
The time to peak (Tmax) of ICP-B161 after single and multiple doses
Time frame: Part A:301 days Part B:321 days
The half-life (t1/2) of ICP-B161 after single and multiple doses
Time frame: Part A:301 days Part B:321 days
The area under the blood concentration-time curve (AUC0-∞ and AUC0-t) of ICP-B161 after single and multiple doses
Time frame: Part A:301 days Part B:321 days
The occurrence rate of antibody of anti-ICP-B161 antibodies
Time frame: Part A:301 days Part B:321 days
The antibody titer of anti-ICP-B161 antibodies
Time frame: Part A:301 days Part B:321 days
The occurrence rate of neutralizing antibodies of anti-ICP-B161 antibodies
Time frame: Part A:301 days Part B:321 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ICP-B161 (SC or IV) in people with Inflammatory Bowel Disease(IBD), run by Beijing InnoCare Pharma Tech Co., Ltd..
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 10 inclusion and 21 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuemei Liu (13552586201, xuemei.liu@gohealtharo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of abnormal vital signs, physical examination findings and abnormal ECG results (time frame: Part A:301 days Part B:321 days). The study lists 3 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 3 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.