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This is a Phase 1, randomized, double-blind, placebo-controlled multiple-ascending dose (MAD) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PHP-303 in otherwise healthy overweight or obese volunteer subjects. Within each ascending dose cohort, subjects will be randomized in a 4:1 ratio to receive PHP-303 or placebo. The primary objective is to establish the safety and tolerability and maximum tolerated dose (MTD) of orally-administered PHP-303.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | PHP-303, multiple oral dose, up to 5 ascending dose cohorts |
|
| Placebo | Placebo Comparator | Placebo, multiple oral dose, up to 5 ascending dose cohorts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PHP-303 | Drug | Investigational drug |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of multiple oral doses of PHP-303 - Incidence of Adverse Events | Assess the number of patients with adverse events | Up to 12 weeks |
| Safety and tolerability of multiple oral doses of PHP-303 - number of patients with abnormal ECG | Number of patients with clinically significant change from baseline in standard 12 lead ECG parameters | Up to 12 weeks |
| Safety and tolerability of multiple oral doses of PHP-303 - blood pressure | Number of patients with clinically significant change from baseline in systolic and diastolic blood pressure | Up to 12 weeks |
| Safety and tolerability of multiple oral doses of PHP-303 - heart rate | Measured as number of heart beats per minute | Up to 12 weeks |
| Safety and tolerability of multiple oral doses of PHP-303 - body temperature | Measurement of oral body temperature | Up to 12 weeks |
| Safety and tolerability of multiple oral doses of PHP-303 - respiratory rate | Measured by number of breaths per minute | Up to 12 weeks |
| Plasma concentration of multiple oral doses of PHP-303 - AUC | Area under the curve | Plasma Up to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Nicholls, MD, PhD | pH Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vince & Associates Clinical Research, Inc. | Overland Park | Kansas | 66212 | United States |
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| Other |
Matching placebo |
|
| Plasma concentration of multiple oral doses of PHP-303 - Cmax |
Maximum observed concentration |
| Up to 12 weeks |
| Plasma concentration of multiple oral doses of PHP-303 - Tmax | Time to reach maximum measured plasma concentration | Up to 12 weeks |
| Plasma concentration of multiple oral doses of PHP-303 - t1/2 | Determination of half-life | Up to 12 weeks |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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