Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06533878
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Evaluate Tolerability and Safety of HY209 in Healthy Volunteers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Part A A Non-randomized Open Single-dose Escalation to Evaluate Tolerability and Safety of Single Oral Dose of HY209 Part B A Block-randomized Double-blinded Placebo-controlled Multiple-dose Escalation to Evaluate Tolerability and Safety of Multiple Oral Doses of HY209 Phase 1 Clinical Trial in Healthy Volunteers
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary study objectives in Parts A and B To determine the Maximum Tolerable DoseMTD of the study drug repeated or single dose
Endpoint Adverse eventAEs including objective and subjective symptoms after the IP dosing as well as physical examinations vital signs ECGs and laboratory tests findings related to the IP dosing
Dose-limiting toxicities DLTs
Justification for endpoints The safety will be assessed comprehensively by performing safety assessment and evaluating relevant variables by dose group
The tolerability will be assessed in DLT analysis set In a first-in-human clinical trial tolerability of the drug administered is usually assessed through determination of dose-limiting toxicity DLT An accurate dose proportionality of toxicity was not observed but toxicity was found at high doses not at low doses following IV and oral administrations except transdermal treatment Thus a relationship between toxicity and doses was confirmed
In addition HY209 showed a dose dependence in some efficacy endpoints including dose-dependent inhibition of release of Tumor Necrosis FactorTNF-α and Il-1β key inflammation factors related to inflammatory bowel disease Thus evaluating the occurrence of DLTs through sequential dose escalation is determined appropriate to assess the tolerability and safety of HY209
Primary study objectives in Part A Dose levels 4-6 To evaluate the effects of food on HY209 bioavailability absorption rate and volume following a single oral dose in healthy volunteers
Endpoint PK of HY209 at a fasting condition and after a high-fat meal Point estimates for the geometric mean ratio of variables Area under concentration-time curveAUC₀-₆ AUCₗₐₛₜ AUC₀- and Cmax and the 90 confidence intervalCI and Tmax
Justification for endpoints For oral drugs effects of food on bioavailability of the drugs are usually evaluated Especially a systemic exposure to bile acid drugs of enterohepatic circulation can be explained with a spillover from the liver to systemic circulatory system Thus a systemic exposure is thought to be affected by food but the actual effects of food are triggered by combination of factors that affect in vivo elution of a drug and absorption of the active pharmaceutical ingredientAPI of the drug As estimating the extent of effects on bioavailability is difficult without conducting an actual food effect study there is a need for clinical evaluation
Endpoint Adverse eventAEs including objective and subjective symptoms after the IP dosing as well as physical examinations vital signs ECGs and laboratory tests findings related to the IP dosing
Dose-limiting toxicities DLTs
Justification for endpoints The safety will be assessed comprehensively by performing safety assessment and evaluating relevant variables by dose group
The tolerability will be assessed in DLT analysis set In a first-in-human clinical trial tolerability of the drug administered is usually assessed through determination of dose-limiting toxicity DLT An accurate dose proportionality of toxicity was not observed but toxicity was found at high doses not at low doses following IV and oral administrations except transdermal treatment Thus a relationship between toxicity and doses was confirmed
In addition HY209 showed a dose dependence in some efficacy endpoints including dose-dependent inhibition of release of Tumor Necrosis FactorTNF-α and Il-1β key inflammation factors related to inflammatory bowel disease Thus evaluating the occurrence of DLTs through sequential dose escalation is determined appropriate to assess the tolerability and safety of HY209
Primary study objectives in Part A Dose levels 4-6 To evaluate the effects of food on HY209 bioavailability absorption rate and volume following a single oral dose in healthy volunteers
Endpoint PK of HY209 at a fasting condition and after a high-fat meal Point estimates for the geometric mean ratio of variables Area under concentration-time curveAUC₀-₆ AUCₗₐₛₜ AUC₀- and Cmax and the 90 confidence intervalCI and Tmax
Justification for endpoints For oral drugs effects of food on bioavailability of the drugs are usually evaluated Especially a systemic exposure to bile acid drugs of enterohepatic circulation can be explained with a spillover from the liver to systemic circulatory system Thus a systemic exposure is thought to be affected by food but the actual effects of food are triggered by combination of factors that affect in vivo elution of a drug and absorption of the active pharmaceutical ingredientAPI of the drug As estimating the extent of effects on bioavailability is difficult without conducting an actual food effect study there is a need for clinical evaluation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None