Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 cohort. Cohort 2 will enroll six healthy subjects. The remaining four cohorts will enroll eight healthy subjects each.
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 Cohorts 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 administered as per the protocol.
Part B: This part consists of two multiple-dose cohorts (Cohorts 8 and 9), each enrolling eight healthy subjects. Subjects in these cohorts will receive subcutaneous doses of HX15001 or placebo on Days 1, 15, and 43. Dosing will be followed by safety, pharmacokinetic, pharmacodynamic, and immunogenicity assessments.
Study Period Part A: Screening:Up to 28 days Treatment:Day 1 single dose Follow up: 112 days including Day 1 (Cohort 1-3) 140 days including Day 1 (Cohort 4-7) Part B: Screening:Up to 28 days Treatment:Day 1, Day 15, Day 43 (single dose on each visit) Follow up: 20 weeks (Day 183) The final follow-up visit will be determined based on the safety and PK data derived from the previous SAD and MAD cohorts, which may be earlier or later than Day 183 (±7 days
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A - Single-Ascending Dose (SAD) | Experimental | Participants will receive a single intravenous dose of HX15001 (Cohort 1-7). |
|
| Placebo SAD Cohorts (1-7) | Placebo Comparator | Participants will receive multiple intravenous dose of Placebo |
|
| Part B - Multiple Ascending Dose (MAD) | Experimental | Participants will receive multiple intravenous doses of HX15001 (Cohort 8-9). |
|
| Placebo MAD Cohorts (8-9) | Placebo Comparator | Participants will receive multiple intravenous dose of Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum concentration after single and multiple ascending doses | Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9) |
| Tmax | Time to reach maximum concentration after single and multiple ascending doses |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tong Gang | Contact | (86)13918569690 | tonggang@helixon.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Q-Pharm Pty Ltd. | Recruiting | Herston | Queensland | 4006 | Australia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D064346 | Sagittal Abdominal Diameter |
| C110804 | mycophenolic adenine dinucleotide |
| ID | Term |
|---|---|
| D049628 | Body Size |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D010808 | Physical Examination |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Participants will receive matching placebo across cohorts 1-7 of the study. |
|
| 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. |
|
| Placebo | Drug | Participants will receive matching placebo across cohorts 8-9 of the study. |
|
| Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9) |
| t1/2 | Half life after single and multiple ascending doses | Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9) |
| AUC | Area under the curve after single and multiple ascending doses | Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9) |
| ADA | Incidence of anti-drug antibody after single and multiple ascending doses | Up to day 113 (cohort 1-3) Up to day 141 (Cohort 4-7) Up to day 183 (Cohort 8-9) |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D000886 | Anthropometry |
| D008919 | Investigative Techniques |
| D010829 | Physiological Phenomena |