Study of HX15001 in Adult Healthy Volunteers.

NCT06999720 | Recruiting Phase 1 DMC

• 1 other identifier: HXN-IMM-001-I
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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 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

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Adverse Events (AEs) and Serious Adverse Events (SAEs) cohort 1-3

  Incidence, severity, and causal relationship of Serious Adverse Events (SAEs) including changes in laboratory parameters (Hematology, Chemistry panels, Coagulation and Urinalysis); 12-lead ECGs parameters; Vital signs (Blood pressure, heart rate, respiratory rate and body temperature)

  Up to day 113

• Adverse Events (AEs) and Serious Adverse Events (SAEs) cohort 4-7

  Incidence, severity, and causal relationship of Serious Adverse Events (SAEs) including changes in laboratory parameters (Hematology, Chemistry panels, Coagulation and Urinalysis); 12-lead ECGs parameters; Vital signs (Blood pressure, heart rate, respiratory rate and body temperature)

  Up to day 141

• Adverse Events (AEs) and Serious Adverse Events (SAEs) cohort 8-9

  Incidence, severity, and causal relationship of Serious Adverse Events (SAEs) including changes in laboratory parameters (Hematology, Chemistry panels, Coagulation and Urinalysis); 12-lead ECGs parameters; Vital signs (Blood pressure, heart rate, respiratory rate and body temperature)

  Up to day 183

Secondary Outcomes (5)

• Cmax

  Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9)

• Tmax

  Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9)

• t1/2

  Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9)

• AUC

  Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9)

• ADA

  Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9)

Study Arms (4)

Part A - Single-Ascending Dose (SAD)

EXPERIMENTAL

Participants will receive a single intravenous dose of HX15001 (Cohort 1-7).

Drug: HX15001 (SAD)

Placebo SAD Cohorts (1-7)

PLACEBO COMPARATOR

Participants will receive multiple intravenous dose of Placebo

Drug: Placebo

Part B - Multiple Ascending Dose (MAD)

EXPERIMENTAL

Participants will receive multiple intravenous doses of HX15001 (Cohort 8-9).

Drug: HX15001 (MAD)

Placebo MAD Cohorts (8-9)

PLACEBO COMPARATOR

Participants will receive multiple intravenous dose of Placebo

Drug: Placebo

Interventions

HX15001 (SAD) DRUG

Part A (Single Ascending Dose), participants will receive a single intravenous dose of HX15001 at escalating dose levels in sequential cohorts (Cohorts 1-7).

Part A - Single-Ascending Dose (SAD)

Placebo DRUG

Participants will receive matching placebo across cohorts 1-7 of the study.

Placebo SAD Cohorts (1-7)

HX15001 (MAD) DRUG

In Part B (Multiple Ascending Dose), participants will receive multiple intravenous doses of HX15001 in cohorts 8 and 9 to assess safety, tolerability, and pharmacokinetics.

Part B - Multiple Ascending Dose (MAD)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Helixon Biotechnology (Suzhou) Co., Ltd: lead

Study Sites (1)

Q-Pharm Pty Ltd.

Herston, Queensland, 4006, Australia

RECRUITING

MeSH Terms

Interventions

Sagittal Abdominal Diameter; mycophenolic adenine dinucleotide

Intervention Hierarchy (Ancestors)

Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena

Central Study Contacts

Tong Gang

CONTACT

(86)13918569690; tonggang@helixon.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: June 11, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)