Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this Phase 1 trial is to evaluate the safety and effects of FB-102 in healthy volunteers following single and multiple doses.
FB-102 will be administered as either a single dose (Part A) or multiple doses (Part B), compared with a placebo control.
Part A (single ascending dose, SAD), participants will receive single dose FB102 will be administered as a single dose.
Part B (multiple ascending dose, MAD), participants will receive multiple doses of FB-102 or placebo.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FB102 Single dose | Experimental | Part A (single ascending dose, SAD), FB102 will be administered as a single dose. |
|
| FB102 Multiple dose | Experimental | Part B (multiple ascending dose, MAD), FB102 will be administered once weekly for 4 doses. |
|
| FB102 Placebo | Placebo Comparator | The placebo will be administered on the same schedule as the corresponding FB-102 cohort. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FB102 Single dose | Drug | FB102 will be administered as a single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, severity, and relationship to treatment of treatment-emergent adverse events (TEAEs) | From day 1 to Day 85 (End of treatment visit) | |
| Incidence, severity, and relationship to treatment of SAEs | From day 1 to Day 85 (End of treatment visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma PK parameters for single dose- maximum serum concentration (Cmax) | Day 1,2,3,4,5,8,15,22,36,50,85 | |
| Plasma PK parameters for single dose- time to maximum concentration (Tmax) | Day 1,2,3,4,5,8,15,22,36,50,85 |
Not provided
Inclusion Criteria:
Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, at Screening.
Weight ≥50 kg and ≤100kg.
Men are required to agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom plus effective contraception for their female partner if of childbearing potential, from Screening and for at least 90 days after the EOT visit and refrain from donating sperm during this period. Effective contraception includes established use of hormonal contraception beginning at least 30 days prior to the Screening visit; or placement of an intrauterine device or intrauterine system. These contraception requirements do not apply if the male participant is in an exclusively same sex relationship; sperm donation prohibitions apply.
Women are eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions apply:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alistair Mallard | Contact | +61 7 5409 8644 | amallard@usc.edu.au |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Indika P Leelasena | University of the sunshine coast clinical trials, Morayfield | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sunshine Coast, Morayfield | Eastwood | Queensland | 4556 | Australia |
Not provided
Not provided
Not provided
Not provided
Not provided
| FB102 Multiple doses | Drug | FB102 will be administered once weekly for 4 doses. |
|
|
| FB102 Placebo | Drug | Matching placebo identical to FB102 formulation but without the active pharmaceutical ingredient |
|
|
| Plasma PK parameters for Multiple dose- maximum serum concentration (Cmax) | Days 1 and 22 |
| Plasma PK parameters for Multiple dose- time to maximum concentration (Tmax) | Days 1 and 22 |