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The goal of this intervention study is to evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HXN5003 in Healthy Participants.The main parameters it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 0 | Experimental | 3 participants |
|
| Cohort 0 - Placebo | Placebo Comparator | 1 Participant |
|
| Cohort 1 | Experimental | 6 participants |
|
| Cohort 1 - Placebo | Placebo Comparator | 2 participants |
|
| Cohort 2 | Experimental | 6 participants |
|
| Cohort 2 - Placebo | Placebo Comparator | 2 Participants |
|
| Cohort 3 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HXN5003 | Drug | Subcutaneous injection (SC) and single dose administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of HXN5003 in healthy participants following single dose | Incidence of adverse events, serious adverse events; Physical examination; Vital signs; 12-lead electrocardiogram parameters; Laboratory tests | Baseline to Day 197 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration of the drug (Cmax) following single dose of HXN5003 in healthy participants | Will be analyzed using standard non-compartmental analysis (NCA) | Baseline to Day 197 |
| Time to peak concentration (Tmax) following single dose of HXN5003 in healthy participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gang Tong | Contact | (86)13918569690 | tonggang@helixon.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veritus Research | Bayswater | Victoria | 3153 | Australia |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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6 participants |
|
| Cohort 3- Placebo | Placebo Comparator | 2 Participants |
|
| Placebo | Drug | Contains the same inactive ingredients as those of HXN5003, but without the active ingredient.Subcutaneous injection (SC) and single dose administration |
|
Will be analyzed using standard non-compartmental analysis (NCA) |
| Baseline to Day 197 |
| Area under the concentration-time curve from time 0 to t (AUC0-t) following single dose of HXN5003 in healthy participants | Will be analyzed using standard non-compartmental analysis (NCA) | Baseline to Day 197 |
| Immunogenicity evaluation of HXN5003 in healthy participants. | Incidence of anti-drug antibody after single ascending dose | Baseline to Day 197 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |