Phase 1 Study to Evaluate PK, Safety, and Tolerability of HRS-5041 in Healthy Caucasian Male Participants

Atridia

Status and phase: Completed; Phase 1

Conditions: Prostate Cancer

Treatments: Drug: HRS-5041 dose level 1; Drug: HRS-5041 dose level 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06559007

HRS-5041-102

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

Experimental: HRS-5041 dose level 1

Experimental group

Description:

Sing dose level 1

Treatment:

Drug: HRS-5041 dose level 1

Experimental: HRS-5041 dose level 2

Experimental group

Description:

Sing dose level 2

Treatment:

Drug: HRS-5041 dose level 2