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| Name | Class |
|---|---|
| Frontage Clinical Services, Inc. | UNKNOWN |
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This study will evaluate the safety, tolerability and pharmacokinetics of 7HP349, an allosteric integrin activator, in healthy male subjects
This first-in-human (FIH) study consists of a placebo-controlled, sequential, dose escalation study to determine the safety, tolerability and pharmacokinetics (PK) of 7HP349 following single and multiple oral dose administration to healthy male subjects, with a separate, open-label food effect cohort at the optimal pharmacokinetic dose (OPD). The study will be carried out in 3 parts.
Part A: This is a placebo-controlled, within-cohort randomized, double-blind, sequential, single ascending dose (SAD) escalation study to determine the safety, tolerability and PK of 7HP349 following administration of single oral doses in healthy male subjects, and to define the OPD of 7HP349.
Part B: This is a placebo-controlled, within-cohort randomized, double-blind, sequential, multiple ascending dose (MAD) escalation study to determine the safety, tolerability and PK of 7HP349 following up to 5 once daily oral doses in healthy male subjects.
Part C: This is a randomized, open label, two-treatment, three-period, crossover study to evaluate the effect of the fed or fasting prandial state on the single dose PK of 7HP349.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 7HP349 Capsules | Experimental | Part A: 7HP349 Capsules (5 cohorts); Part B: 7HP349 Capsules (2 cohorts); Part C: 7HP349 Capsules (3-period cross-over) |
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| Placebo Capsules | Placebo Comparator | Part A: Placebo Capsules (5 cohorts); Part B: Placebo Capsules (2 cohorts) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7HP349 Single Ascending Dose | Drug | Part A: 7HP349 Capsules, Single Ascending Dose (SAD) |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of 7HP349 in healthy male subjects as assessed by incidence of treatment-emergent adverse events according to CTCAE v5.0 criteria | Safety assessments will include evaluation of incidence of treatment-emergent adverse events (AEs) according to CTCAE v5.0 criteria, including vital signs, resting electrocardiogram (ECG) parameters, standard hematology, chemistry, urinalysis and other tests | 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of 7HP349 in healthy male subjects as assessed by maximum plasma concentration (Cmax) towards determination of the optimal pharmacokinetic dose (OPD) | Determination of maximum plasma concentration (Cmax) | 17 days |
| Pharmacokinetics of 7HP349 in healthy male subjects as assessed by plasma exposure (AUClast and/or AUCinf) towards determination of the optimal pharmacokinetic dose (OPD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frontage Clinical Services Inc. | Secaucus | New Jersey | 07094 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 22, 2022 | |
| Reset | Sep 28, 2023 |
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This study consists of three parts, Part A, Part B and Part C, which will be undertaken sequentially. Part A is a SAD study to determine the safety, tolerability and PK of 7HP349 in healthy male subjects, and to define the OPD. Part B is a MAD study to determine the safety, tolerability and PK of 7HP349 following up to 5 once daily oral doses in healthy male subjects. Part C is a crossover study to evaluate the effect of the fed or fasting prandial state on the single dose PK of 7HP349.
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| 7HP349 Multiple Ascending Dose | Drug | Part B: 7HP349 Capsules, Multiple Ascending Dose (MAD) |
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| Placebo Single Ascending Dose | Drug | Part A: Placebo Capsules, Single Ascending Dose (SAD) |
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| Placebo Multiple Ascending Dose | Drug | Part B: Placebo Capsules, Multiple Ascending Dose (MAD) |
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| 7HP349 Food Effect | Drug | Part C: 7HP349 Capsules, Food Effect |
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Determination of plasma exposure (AUClast and/or AUCinf) |
| 17 days |
| Pharmacokinetics of 7HP349 in healthy male subjects as assessed by exposure in urine towards determination of the optimal pharmacokinetic dose (OPD) | Determination of exposure in urine | 17 days |
| Pharmacokinetics of 7HP349 in healthy male subjects as assessed by renal clearance (CLr) towards determination of the optimal pharmacokinetic dose (OPD) | Determination of renal clearance (CLr) | 17 days |
| Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma concentration (Cmax) in fed individuals | Fed prandial state, determination of maximum plasma concentration (Cmax) | 28 days |
| Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma exposure (AUClast and/or AUCinf) in fed individuals | Fed prandial state, determination of plasma exposure (AUClast and/or AUCinf) | 28 days |
| Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma concentration (Cmax) in fasted individuals | Fasted prandial state, determination of maximum plasma concentration (Cmax) | 28 days |
| Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of maximum plasma exposure (AUClast and/or AUCinf) in fasted individuals | Fasted prandial state, determination of plasma exposure (AUClast and/or AUCinf) | 28 days |
| Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of the Geometric Mean Ratio (GMR) of the maximum plasma concentration (Cmax) in fed vs. fasted individuals | Determination of Geometric Mean Ratio (GMR) of fed:fasted Cmax | 28 days |
| Effect of food on the pharmacokinetics of 7HP349 in healthy male subjects as assessed by measurement of the Geometric Mean Ratio (GMR) of the plasma exposure (AUClast and/or AUCinf) in fed vs. fasted individuals | Determination of Geometric Mean Ratio (GMR) of fed:fasted AUClast and/or AUCinf | 28 days |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 22, 2022 | Sep 28, 2023 |