Actively Recruiting
Study of HX15001 in Adult Healthy Volunteers.
Led by Helixon Biotechnology (Suzhou) Co., Ltd · Updated on 2025-08-24
62
Participants Needed
1
Research Sites
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase I, randomized, double-blinded, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HX15001 in adult healthy participants. The study consists of two parts: Part A involves single-dose escalation (Cohorts 1-7), and Part B involves multiple-dose escalation (Cohorts 8-9). The primary objective of this study is to characterize the safety and tolerability of single and multiple doses of HX15001 in healthy subjects.
CONDITIONS
Official Title
Study of HX15001 in Adult Healthy Volunteers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent document
- Healthy males and females aged 18 to 55 years
- Body mass index (BMI) between 18 and 32 kg/m2 and body weight at least 50 kg
- Good health with no significant findings in medical history, physical exam, ECG, vital signs, or lab tests
- Willing and able to understand and comply with study procedures and communicate effectively
You will not qualify if you...
- Females who are pregnant, planning pregnancy, or breastfeeding
- Positive pregnancy test at screening or baseline
- History or positive test for HIV, hepatitis B, hepatitis C, or syphilis
- Risk for tuberculosis (TB)
- Unwilling or unable to follow lifestyle requirements
- Received experimental agents within 30 days or 5 half-lives before dosing
- Donated blood (about 500 mL) within 30 days before dosing or plan to donate during study or 30 days after
- Used prescription or over-the-counter drugs or supplements within 7 days or 5 half-lives before dosing
- ECG showing clinically relevant abnormalities
- Significant surgical or interventional therapy within 6 months or planned during study
- History of drug hypersensitivity or allergic reactions
- Any other condition that increases risk as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Q-Pharm Pty Ltd.
Herston, Queensland, Australia, 4006
Actively Recruiting
Research Team
T
Tong Gang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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