ArticleClinical pharmacokinetics2026
Population Pharmacokinetic/Pharmacodynamic Analysis of HHT120, a Novel Direct Thrombin Inhibitor, in Healthy Participants from a Phase I Clinical Trial.
Article in Clinical pharmacokinetics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionHHT120 is a novel orally administrable direct thrombin inhibitor. In this study, the pharmacokinetic (PK) profiles of HHT120 and its active metabolite Rn-001 were investigated in a first-in-human study and further analyzed with modeling approaches.
methodsPopulation pharmacokinetic (PopPK) model and pharmacokinetic/pharmacodynamic (PK/PD) model were developed to describe the dose-exposure-response relationship after HHT120 administration. Furthermore, the activated partial thromboplastin time (APTT) under different dosing regimens was performed to evaluate the anticoagulant effect.
resultsIn total, 74 healthy participants were involved in the dataset involving single ascending dose (SAD), multiple ascending dose (MAD) as well as food effect (FE) phases, and 918 observations of HHT120 concentration as well as 1697 observations of Rn-001 were collected. A total number of 1314 APTT observations were obtained from 62 subjects excluding FE phase. An Erlang model with 7 transit compartments was utilized in the PopPK model to capture the production of Rn-001, and a three-compartment model was employed to describe the disposition. Covariates were screened on the PK parameters in a stepwise style, and no significant covariate effect was found in the current model. Besides, the relationship of plasma concentration of Rn-001 and APTT was characterized by a direct effect with a mixture of linear and nonlinear models. Simulations showed that HHT120 administered once daily at 100-300 mg or twice daily at 100-200 mg led to an increase of APTT within 2-fold of the upper limit, suggesting good safety profiles of HHT120 in the simulated dose regimens.
conclusionsThe PopPK/PD model offers evidence for the efficacy and safety properties of HHT120 and are expected to provide valuable insights for subsequent clinical research and development of HHT120.
trial registrationChina Drug Trials Registry ( https://www.chinadrugtrials.org.cn ) identifier no. CTR20221837.
Identifiers
42911540What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.