Kidney Week

Abstract: TH-PO0821

A Phase 1 Mass Balance Study of 14C-AND017, a Novel Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor, in Healthy Male Participants

Session Information

• Pharmacology (PharmacoKinetics, -Dynamics, -Genomics)
  October 22, 2026 | Location: Exhibit Hall A, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Pharmacology (PharmacoKinetics, -Dynamics, -Genomics)

• 1900 Pharmacology (PharmacoKinetics, -Dynamics, -Genomics)

Authors

• Zhu, Yusha, Kind Pharmaceuticals LLC, Redwood City, California, United States

Yusha Zhu, MD, PhD

• Zhang, Xuejiao, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China

Xuejiao Zhang

• Chen, Xuemei, Affiliated Hospital of Jiangnan University, Wuxi, Jiangsu, China

Xuemei Chen

• Feng, Hao, Value Pharmaceutical Services Co Ltd, Nanjing, Jiangsu, China

Hao Feng

• Yu, Zhenwen, Value Pharmaceutical Services Co Ltd, Nanjing, Jiangsu, China

Zhenwen Yu

• Hao, Xiaoli, Kind Pharmaceuticals LLC, Redwood City, California, United States

Xiaoli Hao

• Hua, Yingxiao, Kind Pharmaceuticals LLC, Redwood City, California, United States

Yingxiao Hua

• Li, Xiaolu, Kind Pharmaceuticals LLC, Redwood City, California, United States

Xiaolu Li, MD, PhD

• Du, Ping, Kind Pharmaceuticals LLC, Redwood City, California, United States

Ping Du

• Liu, Tingting, Kind Pharmaceuticals LLC, Redwood City, California, United States

Tingting Liu

• Deng, Shaojiang, Kind Pharmaceuticals LLC, Redwood City, California, United States

Shaojiang Deng, PhD

• Zhu, Qi, Kind Pharmaceuticals LLC, Redwood City, California, United States

Qi Zhu, MD

Background

AND017 is an oral hypoxia-inducible factor prolyl-hydroxylase inhibitor (HIF-PHI) developed for the treatment of anemia due to CKD. Clinical development of AND017 is ongoing, with Phase 3 studies currently underway in the United States and China. To support its clinical development and optimize its therapeutic use, a Phase 1 clinical study was conducted to characterize the metabolic pathways and excretion profile of AND017 in humans.

Methods

This was a Phase 1, single-dose, single center, open-label, non-randomized study to examine the mass balance, metabolism and safety of ¹⁴C-AND017 in six healthy male participants. All participants provided written informed consent prior to the initiation of the study. Following a single oral administration of approximately 10 mg/100 μCi of ¹⁴C-AND017, metabolite profiling and structural characterization in human plasma, urine, and feces were performed using liquid chromatography coupled with an online radioactivity detector and high-resolution mass spectrometry (LC/RAM/MS).

Results

In human plasma, the median T_max of AND017 was 2.50 h, and the estimated mean terminal elimination half-life (t_1/2) was 45.7 h. In pooled plasma over AUC_{0–96 h}, the parent drug was the predominant radioactive component, accounting for 100.00% of the total plasma radioactivity exposure. The whole blood-to-plasma total radioactivity ratio ranged from 0.502 to 0.639.
Fecal excretion was the primary route of elimination, with 83.18% of the administered radioactive dose recovered in feces over 0–312 h. The parent drug accounted for 2.42% of the administered dose in feces. The primary metabolic pathways of AND017 in healthy male participants include mono-oxidation, di-oxidation with hydrogenation, and glucuronidation. The predominant fecal metabolite represented 71.79% of the administered dose, while two minor metabolites accounted for 7.91% and 1.06% of the dose, respectively. Urinary excretion represented a minor elimination pathway, with 12.32% of the administered radioactive dose recovered in urine over 0–312 h.
In terms of safety, AND017 were generally well-tolerated among six healthy male participants.

Conclusion

Collectively, these data indicate that AND017 is cleared primarily by metabolism followed by biliary/fecal excretion, with negligible contribution from circulating metabolites, supporting a predictable metabolic profile in humans.