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The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HXN6005 in Healthy Participants.
Researchers will compare HXN6005 to a placebo (a look-alike substance that contains no drug).
Participants will take a single dose of HXN6005 or placebo on Day 1, and visit the clinic for followup and tests per the protocol scheme.
This study consists of 4 Cohorts, including three sequential ascending-dose cohorts (Cohort 1,2 and 4), and one paralleled cohorts (Cohort 3).
The investigator and participants will be blinded to treatment assignment. Participants in different dose groups will be enrolled from the low-dose group to the high-dose group.
Eight healthy participants will be randomly enrolled per cohort. In cohort 1,2 and 4 there will be a sentinel group comprising two participants who will be randomized in a 1:1 ratio to receive either HXN6005 or placebo. In Cohort 3, eight participants will be randomized in a 6:2 ratio to receive HXN6005 or placebo.
Following dosing on Day 1, blood samples will be collected according to the protocol. Participants in Cohorts 1-4 will be followed up to Day 141. The final follow-up visit will be determined based on the safety and PK data derived from the previous single ascending dose (SAD) cohorts, which may be earlier or later than Day 141 (±7 days).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-Ascending Dose (SAD) of HXN6005 | Experimental | Participants will receive a single dose of HXN6005 (Cohort 1-4) |
|
| Single-Ascending Dose (SAD) of placebo | Placebo Comparator | Participants will receive single dose of Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HXN6005 | Drug | participants will receive a single subcutaneous dose of HXN6005 at escalating dose levels in Cohort 1-4, |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Up to Day 141 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum concentration after single ascending dose | Up to Day 141 |
| Tmax | Time to reach maximum concentration after single ascending dose |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory PD biomarker | Change from baseline in serum free TSLP concentration over time | Up to Day 141 |
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 | Recruiting | Bayswater | Victoria | 3153 | Australia |
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| Placebo | Drug | Participants will receive matching placebo across cohorts 1-4 of the study. |
|
| Up to Day 141 |
| t1/2 | Half life after single ascending dose | Up to Day 141 |
| AUC | Area under the concentration-time curve after single ascending dose | Up to Day 141 |
| ADA | Incidence of anti-drug antibody after single ascending dose | Up to Day 141 |