Clinical trial NCT06999720: Study of HX15001 in Adult Healthy Volunteers.
Official title: A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Single Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Pharmacodynamics of HX15001 in Adult Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Helixon Biotechnology (Suzhou) Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-05-31
Enrollment: 46
Sex: ALL
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 I, randomized, double-blinded, placebo-controlled, single dose escalation study to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HX15001 in adult healthy participants.

The primary objective of this study is to characterize the safety and tolerability of single dose of HX15001 in healthy subjects.

Detailed description: This study consists of seven sequential ascending-dose cohorts, designated as 1 through 7. Cohort 1 and Cohort 6 will enroll four healthy subjects in each cohort. Cohort 2 will enroll six healthy subjects. The other 4 cohorts will enroll 8 healthy subjects in each cohort.

On Day 1 after final eligibility has been determined, subjects in Cohorts 1-5 will be randomly assigned to receive a single subcutaneous dose (which may be split into multiple dosing syringes) of HX15001 or placebo, while subjects in Cohort 6 and 7 will be randomly assigned to receive a single intravenous infusion of HX15001 or placebo.

The doses for Cohorts 1-7 will be as per the protocol. Duration of the study is approximately 18 months.

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

Primary outcomes:
measure: Adverse Events (AEs) and Serious Adverse Events (SAEs) cohort 1-3
timeFrame: Up to day 113
measure: Adverse Events (AEs) and Serious Adverse Events (SAEs) cohort 4-7
timeFrame: Up to day 141
Secondary outcomes:
measure: Cmax
timeFrame: Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7)
measure: Tmax
timeFrame: Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7)
measure: t1/2
timeFrame: Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7)
measure: AUC
timeFrame: Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7)
measure: ADA
timeFrame: Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7)
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Q-Pharm Pty Ltd.
state: Queensland
Study officials:
References: