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This is a Multipart Phase 1 Randomized, Double blind and Placebo controlled Study to Determine Safety, Tolerability and Pharmacokinetics, of SCO-120 in healthy male and postmenopausal female volunteers.
Part A- approximately 76 (Approximately 8 sequential cohorts of 8 subjects per cohort)
Part B- Up to approximately, 32 healthy males or post-menopausal female subjects will be enrolled
Part C- Approximately 32 healthy male or postmenopausal female subjects (4 sequential cohorts of 8 subjects) will be enrolled
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCO-120 | Experimental |
| |
| Matching Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCO-120 | Drug | Part A: single oral administration Part B: single oral administration in Period 1 and Period 2 (crossover design) Part C: multiple oral administration (14 day dosing) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0 | Part A: safety and tolerability assessed | Day 14 |
| Part C: Number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0 | Part C: safety and tolerability assessed | Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Part B: Number of subjects with treatment-related adverse events as assessed by CTCAE version 5.0 | Part B: safety and tolerability assessed | Day 42 |
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Inclusion Criteria:
Healthy postmenopausal female volunteers will be included in the study if they meet all of the following criteria:
Part A-
Healthy postmenopausal female subjects, aged > 18 years, Weight over 50 kg and with a body mass index of 18.0 to 33.0 kg/m2 (inclusive) will be included in this part.
Did not donate 50-349 mL blood within 30 days or ≥350 mL blood within 3 months prior to IMP administration and agrees not to make blood donations, including red blood cells, plasma, platelets, or whole blood for the entire study duration.
Part B and C-
Healthy male and postmenopausal female subjects, aged ≥ 18 years, with a body mass index of 18.0 to 33.0 kg/m2 (inclusive) will be included in this part.
Did not donate 50-499 mL blood within 30 days or ≥500 mL blood within 56 days prior to IMP administration and agrees not to make blood donations, including red blood cells, plasma, platelets, or whole blood for the entire study duration
Men who are able to father children must agree to use medically acceptable methods of contraception and NOT donate sperm during the study and for 90 days after the end of the study. Medically acceptable methods of contraception include using a condom with a female partner of child-bearing potential who is using oral contraceptives, hormonal patch, implant or injection, intrauterine device, or diaphragm with spermicide. Abstinence as a method of contraception is acceptable if it is in line with the preferred and usual lifestyle of the study participant.
All parts-
Willing and able to give written, signed and dated informed consent (or by subject's legally acceptable representative/impartial witness when applicable) and is available for the entire study
Willing and able to comply with the scheduled visits, treatment plan, laboratory testing, study procedures, and restrictions (as per section 4.5), and be accessible for follow-up visits
Assessed as healthy based on no clinically significant abnormality identified on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory screening tests
Females who are naturally postmenopausal for at least 12 consecutive months with a follicle-stimulating hormone level of ≥ 40 mIU/mL at screening
Non-smokers or abstain from any tobacco usage, including smokeless tobacco, nicotine patches, etc. for entire study duration including screening period; subjects must have urine cotinine levels below those measured for smokers (< 200 ng/mL) .
Exclusion Criteria:
Subjects will be excluded from the Study if they meet any of the following criteria: (All Parts)
Part A- Healthy postmenopausal female volunteers
Part B & Part C- Healthy Male or postmenopausal female volunteers
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AXIS Clinicals | Dilworth | Minnesota | 56529-1342 | United States | ||
| BioPharma Services USA Inc. |
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| matching placebo | Drug | Part A: single oral administration Part C: multiple oral administration (14 day dosing) |
|
| Creve Coeur |
| Missouri |
| 63141 |
| United States |
| BioPharma Services Inc. | Toronto | Ontario | ON M9L 3A2 | Canada |