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The primary objective of this study is to evaluate the safety and tolerability of D-4517.2 after single subcutaneous (SC) doses in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: 0.25 mg/kg D-4517.2 | Experimental | Participants will be administered a single dose of 0.25 mg/kg D-4517.2. A sentinel participant will be enrolled for each cohort. After the sentinel participant completes Day 3, the safety review committee (SRC) will determine if it is safe to continue with the enrollment of the remaining 3 participants in the cohort. The SRC will also determine the dose escalation to the next cohort. |
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| Cohort 2: 0.5 mg/kg D-4517.2 | Experimental | Participants will be administered a single dose of 0.5 mg/kg D-4517.2. A sentinel participant will be enrolled for each cohort. After the sentinel participant completes Day 3, the SRC will determine if it is safe to continue with the enrollment of the remaining 3 participants in the cohort. The SRC will also determine the dose escalation to the next cohort. |
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| Cohort 3: 1.0 mg/kg D-4517.2 | Experimental | Participants will be administered a single dose of 1.0 mg/kg D-4517.2. A sentinel participant will be enrolled for each cohort. After the sentinel participant completes Day 3, the SRC will determine if it is safe to continue with the enrollment of the remaining 3 participants in the cohort. The SRC will also determine the dose escalation to the next cohort. |
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| Cohort 4: 2.0 mg/kg D-4517.2 | Experimental | Participants will be administered a single dose of 2.0 mg/kg D-4517.2. A sentinel participant will be enrolled for each cohort. After the sentinel participant completes Day 3, the SRC will determine if it is safe to continue with the enrollment of the remaining 3 participants in the cohort. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-4517.2 | Drug | Subcutaneous (SC) injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Day 1 up to Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of D-4517.2 | Day 1 up to Day 3 | |
| Time to Maximum Plasma Concentration (tmax) of D-4517.2 | Day 1 up to Day 3 | |
| Apparent Terminal Rate Constant (kel) of D-4517.2 |
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Inclusion Criteria:
Is a healthy man or woman age 18 to 65 years, inclusive, at the Screening Visit;
Has the ability to understand and sign the written informed consent form (ICF) and local medical privacy authorization forms, which must be obtained prior to any study related procedures being completed;
Body mass index (BMI) between 18 and 32 kg/m^2, inclusive, with body weight ≤ 100 kg;
Is in general good health, based upon the results of a medical history assessment, physical examination, vital signs, and laboratory profile, as judged by the Investigator;
Female participants of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or postmenopausal, defined as spontaneous amenorrhea for at least 1 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at screening, based on the central laboratory's ranges;
Female participants of childbearing potential (i.e., ovulating, premenopausal, and not surgically sterile) and all male participants must use a medically accepted contraceptive regimen (including hormonal contraceptives) during their participation in the study and for 30 days after the last administration of study drug. Medically accepted contraceptive methods are defined as those with 90% or greater efficacy;
Acceptable methods of contraception for male participants enrolled in the study include the following:
• Condoms or surgical sterilization of participant at least 26 weeks before the Screening Visit (vasectomy);
Acceptable methods of contraception for female participants enrolled in the study include the following:
If male, participants must agree to abstain from sperm donation through 90 days after administration of the last dose of study drug;
Female participants may not be pregnant, lactating, or breastfeeding;
Female participants of childbearing potential must have negative result for pregnancy test at screening and Check-in;
Participants must have a negative test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVab), and human immunodeficiency virus (HIV) antibody at screening;
Participants must have an estimated glomerular filtration rate (eGFR) of ≥60 mL/min/1.73m^2 at screening;
Participants must have a negative urine test for drugs of abuse, cotinine, and breath alcohol test at screening and Check-in; and
Participants must be willing and able to abide by all study requirements and restrictions.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nucleus Network (Brisbane) | Brisbane | Queensland | 4006 | Australia |
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| Day 1 up to Day 3 |
| Apparent Elimination Half-life (t1/2) of D-4517.2 | Day 1 up to Day 3 |
| Area Under the Concentration-time Curve Based On the Last Measurable Concentration (AUC0-t) | Day 1 up to Day 3 |
| Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-inf) | Day 1 up to Day 3 |
| Clearance (CL) of D-4517.2 | Day 1 up to Day 3 |