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| ID | Type | Description | Link |
|---|---|---|---|
| 297628 | Other Identifier | Health Canada CTA control number |
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This study aims to assess the safety and tolerability of ABCL575 in healthy participants following single ascending dose (SAD), in comparison to a placebo
This is a phase I randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. The study will consist of 5 planned cohorts (A1 to A5), each comprised of 8 healthy participants. Doses of ABCL575 are intended to escalate through cohorts A1 to A5.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABCL575 | Experimental | Healthy participants will receive a single dose of ABCL575 administered by subcutaneous (SC) injection |
|
| Placebo | Placebo Comparator | Healthy participants will receive a single dose of placebo administered by subcutaneous (SC) injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABCL575 | Biological | Participants will receive SC injection of ABCL575 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, frequency, and severity of adverse events (AEs) | Day 0 to day 337 | |
| Changes from baseline in laboratory parameters including general biochemistry, lipid profile, coagulation, hematology, and urinalysis | Day 0 to day 337 | |
| Changes from baseline in physical examination | Day 0 to day 337 | |
| Changes from baseline in vital signs | Day 0 to day 337 | |
| Changes from baseline in 12-lead safety ECGs | Day 0 to day 337 | |
| Incidence and severity of injection site reactions | Day 0 to day 337 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of ABCL575 | Day 0 to day 337 | |
| Incidence of anti-ABCL575 antibodies | Day 0 to day 337 | |
| PK parameters; maximum plasma concentration (Cmax) |
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Inclusion Criteria:
Healthy male or female ≥ 18 and ≤ 65 years of age at the time of screening
Good general health as determined through medical history and general physical examination
Body weight ≥ 50 and ≤ 100 Kg
Body mass index (BMI) between 18.5 kg/m2 and 30.0 kg/m2
Non- or ex-smoker (an ex-smoker defined as someone who has completely stopped using nicotine products for at least 180 days prior to study drug administration)
Meeting 1 of the following:
If male, agrees not to donate sperm from the study drug administration through EOS visit; If female, agrees not to donate or retrieve eggs from the study drug administration through EOS visit
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Sicard | Altasciences Company Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Company Inc. | Mount Royal | Quebec | H3P 3P1 | Canada |
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| Placebo (Normal Saline 0.9%) |
| Biological |
Participants will receive SC injection of placebo (Normal Saline 0.9%) |
|
| Day 0 to day 337 |
| PK parameters; time to maximum plasma concentration (Tmax) | Day 0 to day 337 |
| PK parameters; area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUC0-T) | Day 0 to day 337 |
| PK parameters; area under the plasma concentration-time curve from zero to hour 672 (AUC0-672) | Day 0 to day 337 |
| PK parameters; area under the plasma concentration-time curve from zero to infinity (AUC0-∞) | Day 0 to day 337 |
| PK parameters; terminal rate constant (λz) | Day 0 to day 337 |
| PK parameters; apparent plasma clearance of drug after extravascular administration (CL/F) | Day 0 to day 337 |
| PK parameters; apparent volume of distribution after extravascular administration (Vz/F) | Day 0 to day 337 |
| PK parameters; half-life (Thalf) | Day 0 to day 337 |