Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HY8931 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| HY8931 | EXPERIMENTAL | It's an injection solution. SAD part for intravenous dosing in 6 cohorts, including 10mg, 30mg, 60mg, 120mg, 240mg and 360mg with only one administration on Day 1 of each cohort. SAD part for subcutaneous dosing in 120mg cohort with only one administration on Day 1; MAD part for subcutaneous dosing in 3 cohorts, including 120mg, 240mg, 360mg with two administrations on Day 1 and Day 30 of each cohort. |
| placebo | PLACEBO_COMPARATOR | It's same injection solution just without active ingredient compared with HY8931. SAD part for intravenous dosing in 6 cohorts, including 10mg, 30mg, 60mg, 120mg, 240mg and 360mg with only one administration on Day 1 of each cohort. SAD part for subcutaneous dosing in 120mg cohort with only one administration on Day 1; MAD part for subcutaneous dosing in 3 cohorts, including 120mg, 240mg, 360mg with two administrations on Day 1 and Day 30 of each cohort. |
| Name | Type | Description |
|---|---|---|
| HY8931 | BIOLOGICAL | HY8931 is an injection solution with 125mg/ml per vial. SAD part for intravenous dosing in 6 cohorts, including 10mg, 30mg, 60mg, 120mg, 240mg and 360mg and for subcutaneous dosing in 1 cohort of 120mg with only one administration on Day 1 of each cohort. MAD part for subcutaneous dosing in 3 cohorts, including 120mg, 240mg and 360mg with two administrations on Day 1 and Day 30 of each cohort. |
| Placebo Control | OTHER | A vial with 1ml injection solution contain same ingredient except HY8931 compared with HY8931 solution. |
Inclusion Criteria: 1. Male and female participants must be 18 to 45 years of age, inclusive, at the time of signing the informed consent. 2. Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, v...
HY8931 is an investigational monoclonal antibody being studied in healthy adult participants. It is currently in Phase 1 clinical development, with the primary focus on evaluating its safety, tolerability, and pharmacokinetics. The drug is not approved for any condition and is being tested in a clinical trial setting.
HY8931 is being developed by Genelux Corporation, a biopharmaceutical company traded on the stock exchange under the ticker symbol GNLX. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety and pharmacokinetic profile in healthy volunteers.
HY8931 is in Phase 1 clinical development. The ongoing trial is a randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetics of the drug in healthy adult participants. It is currently recruiting participants and is not yet approved by regulatory authorities.
HY8931 is being studied in a Phase 1 clinical trial with the identifier NCT07281703. This trial is titled 'Evaluation of the Safety, Tolerability and Pharmacokinetics of HY8931 in Healthy Adult Participants' and is currently recruiting. The study is randomized, double-blind, and placebo-controlled, with an enrollment target of 60 participants in Australia.
HY8931 is a monoclonal antibody, a type of biologic drug designed to bind to specific targets in the body. However, the specific molecular target of HY8931 has not been disclosed. The drug is being evaluated for its safety and pharmacokinetic profile in healthy volunteers as part of its early clinical development.