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The goal of this clinical trial is to learn which dose of study drug IBIO-600 has the right balance of safety, tolerability and impact on body composition in overweight and obese adult participants.
The study is a single ascending dose study, with participants monitored for 9 months after administration.
This clinical trial will seek to address the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBIO-600 (Cohort 1) | Experimental |
| |
| IBIO-600 (Cohort 2) | Experimental |
| |
| IBIO-600 (Cohort 3) | Experimental |
| |
| IBIO-600 (Cohort 4) | Experimental |
| |
| Placebo | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBIO-600 | Drug | IBIO-600 Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the safety and tolerability of a single dose of IBIO-600 | Incidence, severity, and relationship to study treatment of TEAEs and SAEs, as determined by clinical laboratory evaluations, vital signs, physical examinations, and ECGs. | From Day 1 through Day 252 (end of study). |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of a single dose of IBIO-600 | Maximum observed serum concentration (Cmax) | Baseline up to Week 36 |
| Pharmacokinetics of a single dose of IBIO-600 | Time to maximum concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cory Schwartz, PhD | Contact | 979-446-0027 | IBIO-600-CT001@ibioinc.com |
| Name | Affiliation | Role |
|---|---|---|
| Cory Schwartz, PhD | iBio, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veritus Research | Recruiting | Bayswater | Victoria | 3153 | Australia |
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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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| Placebo | Drug | Matching placebo; subcutaneous injection |
|
| Baseline up to Week 36 |
| Pharmacokinetics of a single dose of IBIO-600 | Area under the curve (AUC) | Baseline to the last measurable concentration (AUC0-last) |
| Pharmacokinetics of a single dose of IBIO-600 | AUC | Baseline to infinity (AUC0-inf) |
| Pharmacokinetics of a single dose if IBIO-600 | t½: half-life | Baseline up to Week 36 |
| Pharmacokinetics of a single dose of IBIO-600 | Apparent total body clearance (CL/F) | Baseline through Week 36 |
| Pharmacokinetics of a single dose of IBIO-600 | Apparent volume of distribution (Vz/F) | Baseline up to Week 36 |
| Pharmacodynamics (PD) of a single dose of IBIO-600 | Change in circulating concentrations of total GDF8 | Baseline through Week 36 |
| Pharmacodynamics of a single dose of IBIO-600 | Change in circulating concentrations of total GDF11 | Baseline up to Week 36 |
| Pharmacodynamics of a single dose of IBIO-600 | Change in lipid panel tests | Baseline up to Week 36 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |