A Phase 1, Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISM9528
NCT07932041, Phase 1, Recruiting, InSilico Medicine Hong Kong Limited
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Phase 1, Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISM9528 | ClinicalTrials.gov |
| NCT number | NCT07932041 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 1 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | InSilico Medicine Hong Kong Limited | ClinicalTrials.gov |
| Conditions | Healthy Subjects (HS) | ClinicalTrials.gov |
| Interventions | ISM9528 capsules | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | The incidence of Adverse Events (AEs) after single dose of ISM9528 capsules. | Up to 28 days after last dose. | To evaluate the safety and tolerability of ISM9528. | ClinicalTrials.gov |
| Primary | The incidence of abnormalities in vital signs measurements, 12-lead ECG, physical examinations,CNS safety battery,C-SSRS(Columbia Suicidality Severity Rating Scale) and clinical laboratory test. | Up to 48 hours after last dose. | To evaluate the safety and tolerability of ISM9528. | ClinicalTrials.gov |
| Secondary | Maximal observed plasma concentration (Cmax). | From pre-dose through at least 48 hours post-dose, depending on the dose period. | To characterize plasma PK of ISM9528 after each single dose. | ClinicalTrials.gov |
| Secondary | Time when the maximal concentration is observed (Tmax). | From pre-dose through at least 48 hours post-dose, depending on the dose period. | To characterize plasma PK of ISM9528 after each single dose. | ClinicalTrials.gov |
| Secondary | Area under the concentration-time curve from time zero to the last observed concentration (AUC0-t). | From pre-dose through at least 48 hours post-dose, depending on the dose period. | To characterize plasma PK of ISM9528 after each single dose. | ClinicalTrials.gov |
| Secondary | Area under the concentration-time curve from time zero to infinity (extrapolated)(AUC0-inf). | From pre-dose through at least 48 hours post-dose, depending on the dose period. | To characterize plasma PK of ISM9528 after each single dose. | ClinicalTrials.gov |
| Secondary | Terminal elimination half-life(T½). | From pre-dose through at least 48 hours post-dose, depending on the dose period. | To characterize plasma PK of ISM9528 after each single dose. | ClinicalTrials.gov |
| Secondary | Apparent clearance (CL/F). | From pre-dose through at least 48 hours post-dose, depending on the dose period. | To characterize plasma PK of ISM9528 after each single dose. | ClinicalTrials.gov |
| Secondary | Apparent Volume of Distribution(Vz/F) | From pre-dose through at least 48 hours post-dose, depending on the dose period. | To characterize plasma PK of ISM9528 after each single dose. | ClinicalTrials.gov |
| Secondary | Percentage of AUC0-inf Obtained by Extrapolation(%AUCex). | From pre-dose through at least 48 hours post-dose, depending on the dose period. | To characterize plasma PK of ISM9528 after each single dose. | ClinicalTrials.gov |
| Secondary | Terminal Elimination Rate Constant(Kel) | From pre-dose through at least 48 hours post-dose, depending on the dose period. | To characterize plasma PK of ISM9528 after each single dose. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)