Trial · NCT07887490
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Recombinant Anfibatide Injection in Healthy Volunteers
NCT07887490, Phase 1, Not yet recruiting, Lee's Pharmaceutical Limited
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Recombinant Anfibatide Injection in Healthy Volunteers. Trials, record NCT07887490. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07887490
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Recombinant Anfibatide Injection in Healthy Volunteers
- NCT number
- NCT07887490
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 36 participants, estimated
- Lead sponsor
- Lee's Pharmaceutical Limited
- Conditions
- Healthy Volunteers
- Interventions
- Recombinant Anfibatide Injection, Placebo
- First posted
- 2026-10-21
- Last updated
- 2026-10-21
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) | From dosing through Day 8 follow-up visit | Safety and tolerability assessed by the incidence, severity, and relationship of adverse events, graded per NCI CTCAE v6.0, including abnormal laboratory values, vital signs, ECG, and physical examination findings. |
| Secondary | Time to Maximum Observed Concentration (Tmax) of Recombinant Anfibatide | Pre-dose through 48 hours post-dose | Time from dosing to reach the peak concentration of recombinant anfibatide, measured at scheduled time points. |
| Secondary | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) | Pre-dose through 48 hours post-dose | Area under the concentration-time curve of recombinant anfibatide from time zero to the last quantifiable concentration, based on scheduled post-dose measurements. |
| Secondary | Maximum Observed Concentration (Cmax) of Recombinant Anfibatide | Pre-dose through 48 hours post-dose | Peak concentration of recombinant anfibatide following single intravenous administration, measured at scheduled time points. |
| Secondary | Platelet Aggregation Inhibition Rate (Ristocetin-induced) | Pre-dose through 48 hours post-dose | Inhibition rate of ristocetin-induced platelet aggregation measured at scheduled time points after single dose administration. |
| Secondary | Glycoprotein Ib (GP-Ib) Receptor Binding Rate | Pre-dose through 48 hours post-dose | GP-Ib receptor binding rate measured at scheduled time points after single dose administration. |
| Secondary | Number of Participants With Positive Anti-drug Antibody (ADA) | Pre-dose and Day 8 post-dose | Number of participants who tested positive for anti-drug antibody after single dose administration. |
| Secondary | Number of Participants With Positive Neutralizing Antibody (Nab) | Pre-dose and Day 8 post-dose | Number of participants who tested positive for neutralizing antibody after single dose administration. |
| Secondary | Cumulative Urinary Excretion Amount of Recombinant Anfibatide | Pre-dose through 48 hours post-dose | Total amount of recombinant anfibatide recovered in urine over scheduled collection intervals. |
| Secondary | Cumulative Urinary Excretion Percentage of Recombinant Anfibatide | Pre-dose through 48 hours post-dose | Percentage of the administered dose recovered in urine over scheduled collection intervals. |
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT07887490
GET https://conductscience.org/api/trials/v1/NCT07887490/registered