Status:
RECRUITING
Study of HX15001 in Adult Healthy Volunteers.
Lead Sponsor:
Helixon Biotechnology (Suzhou) Co., Ltd
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
This study consists of two parts. Part A: This part includes seven sequential ascending-dose cohorts, designated as Cohorts 1 through 7. Cohort 1 and Cohort 6 will enroll four healthy subjects in each...
Eligibility Criteria
Inclusion
- An informed consent document signed and dated by the subject.
- Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
- Have a Body mass index (BMI) of 18-32 kg/m2 , inclusive; with body weight ≥50 kg during the screening.
- In good health, as determined by the investigator at Screening procedures, with no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations.
- Subjects must be willing to understand and comply with all research procedures and restrictions, and able to communicate effectively with researchers.
Exclusion
- Females who are pregnant, planning to become pregnant, or breastfeeding during the trial.
- Has a positive result of pregnancy test at Screening or Baseline
- History of HIV infection, hepatitis B, hepatitis C or syphilis; positive testing for HIV, hepatitis B, HCV Ab or serological reaction of syphilis
- Subjects at risk for tuberculosis (TB).
- Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol;
- Has received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 30 days or 5 half-lives prior to dosing, or plan to receive another experimental agent during the duration of this trial;
- Subjects who have donated blood (excluding plasma donations) of approximately 1 pint (500 mL) or more within 30 days prior to dosing, or those who plan to donate blood during the study period or within 30 days after the end of the study;
- Use of prescription or over-the-counter drugs or dietary or herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to dosing
- Triplicate 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
- Has clinically significant interventional therapies (surgery, paracentesis, etc.) within 6 months prior to dosing, or plan to have any surgeries during the duration the trial.
- History of any hypersensitivity or allergic reaction to drugs;
- Has any other conditions that would, in the opinion of the investigator, put the subjects at increased risk for participation in this trial
Key Trial Info
Start Date :
June 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT06999720
Start Date
June 11 2025
End Date
September 30 2026
Last Update
August 24 2025
Active Locations (1)
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1
Q-Pharm Pty Ltd.
Herston, Queensland, Australia, 4006