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Trial Title:
Phase 1 Study to Evaluate PK, Safety, and Tolerability of HRS-5041 in Healthy Caucasian Male Participants
NCT ID:
NCT06559007
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HRS-5041 dose level 1
Description:
Single dose of HRS-5041 orally administered
Arm group label:
Experimental: HRS-5041 dose level 1
Other name:
HRS-5041 (single dose, oral administration, dose level 1)
Intervention type:
Drug
Intervention name:
HRS-5041 dose level 2
Description:
Single dose of HRS-5041 orally administered
Arm group label:
Experimental: HRS-5041 dose level 2
Other name:
HRS-5041 (single dose, oral administration, dose level 2)
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.
Criteria for 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.
Gender:
Male
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
55 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Nucleus Network Melbourne
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Recruiting
Contact:
Phone:
1800 243 733
Email:
melbourne@nucleusnetwork.com
Start date:
September 25, 2024
Completion date:
December 15, 2024
Lead sponsor:
Agency:
Atridia Pty Ltd.
Agency class:
Industry
Source:
Atridia Pty Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06559007
