Clinical trial · Interventional
Phase 1 Study to Evaluate PK, Safety, and Tolerability of HRS-5041 in Healthy Caucasian Male Participants
A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Dose HRS-5041 in Healthy Caucasian Male Participants
NCT06559007CI-TRIAL-00087346completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase 1, open-label, randomized study. The objective of this study is to evaluate the PK, safety and tolerability of orally administered single-dose HRS-5041 in healthy Caucasian male participants.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRS-5041 dose level 1 | Drug | — | UNRESOLVED |
| HRS-5041 dose level 2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: HRS-5041 dose level 1
- description
- Sing dose level 1
- interventionNames
- Drug: HRS-5041 dose level 1
- type
- EXPERIMENTAL
- label
- Experimental: HRS-5041 dose level 2
- description
- Sing dose level 2
- interventionNames
- Drug: HRS-5041 dose level 2
Primary outcomes (7)
- measure
- PK profile (Cmax) of HRS-5041 after a single oral (PO) administration:
- timeFrame
- Day 10
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: 1. Healthy Caucasian participants; 2. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial, 3. Male aged between 18 to 55 years of age (inclusive) at the date of signed consent form. 4. Total body weight ≥ 50.0 kg, body mass index (BMI) between 19.0 and 32.0 kg/m2 (inclusive) at screening. Exclusion Criteria: 1. History of receiving any androgen receptor (AR) degraders. 2. History or evidence of clinically significant 3. History of severe abnormal gastric emptying, severe gastrointestinal (GI) disease, or participants who had GI surgeries (except GI polypectomy). 4. Severe infections, injuries, or major surgeries as determined by the investigator within 6 months 5. Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response.
References
Publications (0)
Data not yet available
No reference posted for this study.