Trial · NCT07911982
Safety, Tolerability and Pharmacokinetics of ICP-B161 in Healthy Adults Volunteers
NCT07911982, Phase 1, Not yet recruiting, Beijing InnoCare Pharma Tech Co., Ltd.
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Safety, Tolerability and Pharmacokinetics of ICP-B161 in Healthy Adults Volunteers. Trials, record NCT07911982. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07911982
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability and Pharmacokinetics of ICP-B161 in Healthy Adults Volunteers
- NCT number
- NCT07911982
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 88 participants, estimated
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Conditions
- Inflammatory Bowel Disease(IBD)
- Interventions
- ICP-B161 (SC or IV), Placebo (SC or IV)
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of abnormal vital signs, physical examination findings and abnormal ECG results | 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 |
| Primary | Specific assessments to evaluate the incidence, severity and relationship of adverse events (AEs) | 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 |
| Primary | Incidence of abnormal clinical laboratory test results | 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) |
| Secondary | The peak concentration (Cmax) of ICP-B161 after single and multiple doses | Part A:301 days Part B:321 days | Specific assessments to evaluate the peak concentration (Cmax) of ICP-B161 |
| Secondary | The time to peak (Tmax) of ICP-B161 after single and multiple doses | Part A:301 days Part B:321 days | Specific assessments to evaluate the time to peak (Tmax) of ICP-B161 |
| Secondary | The half-life (t1/2) of ICP-B161 after single and multiple doses | Part A:301 days Part B:321 days | Specific assessments to evaluate the half-life (t1/2) of ICP-B161 |
| Secondary | The area under the blood concentration-time curve (AUC0-∞ and AUC0-t) of ICP-B161 after single and multiple doses | Part A:301 days Part B:321 days | Specific assessments to evaluate the area under the blood concentration-time curve (AUC0-∞ and AUC0-t) of ICP-B161 |
| Secondary | The occurrence rate of antibody of anti-ICP-B161 antibodies | Part A:301 days Part B:321 days | Specific assessments to evaluate the occurrence rate of anti-ICP-B161 antibodies |
| Secondary | The antibody titer of anti-ICP-B161 antibodies | Part A:301 days Part B:321 days | Specific assessments to evaluate the antibody titer of anti-ICP-B161 antibodies |
| Secondary | The occurrence rate of neutralizing antibodies of anti-ICP-B161 antibodies | Part A:301 days Part B:321 days | Specific assessments to evaluate the occurrence rate of neutralizing antibodies of anti-ICP-B161 antibodies |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07911982
GET https://conductscience.org/api/trials/v1/NCT07911982/registered