HX15001 in healthy adults

A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Single Dose and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamics of HX15001 in Adult Healthy Volunteers.

This tests whether single and multiple doses of HX15001 are safe and how the body absorbs and clears it in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Helixon Biotechnology (Suzhou) Co., Ltd (Industry-sponsored)
• Locations: 1 site (Herston, Queensland)
• Trial ID: NCT06999720 on ClinicalTrials.gov

What this trial studies

This Phase 1, randomized, double-blind, placebo-controlled study uses single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts to characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HX15001. Part A includes seven sequential SAD cohorts with subcutaneous dosing for Cohorts 1–5 and intravenous infusions for Cohorts 6–7. Part B includes two MAD cohorts with subcutaneous doses on Days 1, 15, and 43. Cohort sizes range from four to eight participants, and follow-up extends up to about 20 weeks to monitor safety and drug exposure.

Who should consider this trial

Good fit: Healthy adults aged 18–55 with a BMI of 18–32 kg/m2, body weight ≥50 kg, and no clinically significant medical problems are ideal candidates.

Not a fit: People who are pregnant or breastfeeding, outside the age or BMI limits, have positive HIV/hepatitis tests, or have active medical conditions will not be eligible and are unlikely to benefit from participation.

Why it matters

Potential benefit: If HX15001 is safe, the results could identify appropriate dosing and support future patient studies.

How similar studies have performed: The SAD/MAD randomized, placebo-controlled design is a standard first-in-human approach, but HX15001 itself has not yet reported human results.

Eligibility criteria

Inclusion Criteria:

1. An informed consent document signed and dated by the subject.
2. Healthy male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive.
3. Have a Body mass index (BMI) of 18-32 kg/m2 , inclusive; with body weight ≥50 kg during the screening.
4. 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.
5. Subjects must be willing to understand and comply with all research procedures and restrictions, and able to communicate effectively with researchers.

Exclusion Criteria:

1. Females who are pregnant, planning to become pregnant, or breastfeeding during the trial.
2. Has a positive result of pregnancy test at Screening or Baseline
3. History of HIV infection, hepatitis B, hepatitis C or syphilis; positive testing for HIV, hepatitis B, HCV Ab or serological reaction of syphilis
4. Subjects at risk for tuberculosis (TB).
5. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol;
6. 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;
7. 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;
8. 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
9. Triplicate 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
10. 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.
11. History of any hypersensitivity or allergic reaction to drugs;
12. Has any other conditions that would, in the opinion of the investigator, put the subjects at increased risk for participation in this trial

Where this trial is running

Herston, Queensland

• Q-Pharm Pty Ltd. — Herston, Queensland, Australia (Recruiting)

Study contacts

• Study coordinator: Tong Gang

Conditions Healthy Volunteers