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The main objective of the study is to assess the relative bioavailability of KAI-9531 subcutaneous (SC) injection in the upper arm and thigh compared to the abdomen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KAI-9531: Abdomen Injection Site | Experimental | Participants will receive KAI-9531 as a SC injection into the abdomen on Day 1 of either Treatment Period 1, 2 or 3. |
|
| KAI-9531: Thigh Injection Site | Experimental | Participants will receive KAI-9531 as a SC injection into the thigh on Day 1 of either Treatment Period 1, 2 or 3. |
|
| KAI-9531: Upper Arm Injection Site | Experimental | Participants will receive KAI-9531 as a SC injection into the upper arm on Day 1 of either Treatment Period 1, 2 or 3. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KAI-9531 | Drug | SC Injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of KAI-9531 | Treatment Period 1, 2 and 3: Pre-dose and up to 672 hours post-dose | |
| Area Under the Concentration-time Curve From 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-9531 | Treatment Period 1, 2 and 3: Pre-dose and up to 672 hours post-dose | |
| Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of KAI-9531 | Treatment Period 1, 2 and 3: Pre-dose and up to 672 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE) | Day 1 to Day 113 | |
| Number of Participants Who Experience a Serious Adverse Event (SAE) | Day 1 to Day 113 | |
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Inclusion Criteria:
Exclusion Criteria:
Note: Additional inclusion/exclusion criteria may apply, per protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Number of Participants Who Experience Antidrug Antibodies to KAI-9531 |
| Day 1 to Day 113 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |