Clinical trial NCT06559007: Phase 1 Study to Evaluate PK, Safety, and Tolerability of HRS-5041 in Healthy Caucasian Male Participants
Official title: A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Dose HRS-5041 in Healthy Caucasian Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Lead sponsor: Atridia Pty Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-19
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: PK profile (Cmax) of HRS-5041 after a single oral (PO) administration:
timeFrame: Day 10
measure: PK profile (AUC0-t) of HRS-5041 after a single oral (PO) administration:
timeFrame: Day 10
measure: PK profile (AUC0-inf) of HRS-5041 after a single oral (PO) administration:
timeFrame: Day 10
measure: PK profile (Tmax) of HRS-5041 after a single oral (PO) administration:
timeFrame: Day 10
measure: PK profile ( t1/2) of HRS-5041 after a single oral (PO) administration:
timeFrame: Day 10
measure: PK profile (CL/F) of HRS-5041 after a single oral (PO) administration:
timeFrame: Day 10
measure: PK profile (Vz/F) of HRS-5041 after a single oral (PO) administration:
timeFrame: Day 10
Secondary outcomes:
measure: Safety and tolerability - number and severity of adverse events
timeFrame: Day 10
measure: Safety and tolerability - Blood pressure
timeFrame: Day 10
measure: Safety and tolerability - Body temperature
timeFrame: Day 10
measure: Safety and tolerability - Physical examination
timeFrame: Day 10
measure: Safety and tolerability - Laboratory tests
timeFrame: Day 10
measure: Safety and tolerability - ECG
timeFrame: Day 10
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network Melbourne
state: Victoria
Study officials:
References: