Approval Probability
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Adjusted LOA
ML Risk
ABCL635 · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| ABCL635 Part A | EXPERIMENTAL | Part A: healthy male and female participants will receive a single dose of ABCL635 administered by subcutaneous (SC) injection |
| Placebo Part A | PLACEBO_COMPARATOR | Part A: Healthy male and female participants will receive a single dose of placebo (dextrose 5% solution) administered by SC injection |
| ABCL635 Part B | EXPERIMENTAL | Part B: healthy postmenopausal women with or without VMS will receive up to 3 doses of ABCL635 administered by SC injection |
| Placebo Part B | PLACEBO_COMPARATOR | Part B: healthy postmenopausal women with or without VMS will receive up to 3 doses of placebo (dextrose 5% solution) administered by SC injection |
| ABCL635 Part C | EXPERIMENTAL | Part C: postmenopausal women with moderate to severe VMS will receive a single dose of ABCL635 administered by SC injection |
| Placebo Part C | PLACEBO_COMPARATOR | Part C: postmenopausal women with moderate to severe VMS will receive a single dose of placebo (dextrose 5% solution) administered by SC injection |
| ABCL635 Part C OLE | EXPERIMENTAL | Part C open label extension (OLE): postmenopausal women with moderate to severe VMS will receive a single dose of ABCL635 administered by SC injection upon completion of 12-week assessment. |
| Name | Type | Description |
|---|---|---|
| ABCL635 | BIOLOGICAL | Participants will receive SC administrations of ABCL635 |
| Placebo | BIOLOGICAL | Participants will receive SC administration of placebo (5% dextrose solution) |
Inclusion Criteria: * Good general health as determined through a review of their medical history and after conducting a general physical examination * Body weight ≥ 45 to ≤ 120 kg * Body mass index (BMI) between 18.5 kg/m2 and 35.0 kg/m2 * Non- or ex-smoker (an ex-smoker is defined as someone who ...
ABCL635 is an investigational monoclonal antibody being developed for vasomotor symptoms associated with menopause. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
ABCL635 targets NK3R, a receptor involved in the regulation of body temperature and hormone signaling. By binding to this receptor, the antibody is designed to modulate pathways implicated in vasomotor symptoms associated with menopause.
ABCL635 is being developed by AbCellera Biologics Inc., a biotechnology company traded on the Nasdaq under the ticker symbol ABCL. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy.
ABCL635 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency and is still undergoing clinical trials to assess its safety and effectiveness.
ABCL635 is being evaluated in a Phase 1 clinical trial registered as NCT07118891. This randomized, double-blind, placebo-controlled study is assessing the drug in 136 participants, including healthy volunteers and individuals with vasomotor symptoms associated with menopause, at sites in Canada.
Yes, the Phase 1 clinical trial of ABCL635 (NCT07118891) includes healthy volunteers as well as participants with vasomotor symptoms associated with menopause. The study is enrolling adults aged 40 years and older and is currently active but not recruiting participants.