Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:27 PM
Ignite Modification Date:
2025-12-24 @ 6:27 PM
NCT ID:
NCT05905068
Eligibility Criteria:
Inclusion Criteria:
1. Male and female subjects, aged 18 to 60 years, inclusive.
2. Body mass index between 18 and 32 kg/m2, inclusive, with body weight \> 45 kg for females and \>50 kg for males.
3. Serum LDL-C ≥100mg/dL (2.6 mmol/L) at screening and Day -1.
4. Fasting triglycerides \< 400 mg/dL (\<4.52 mmol/L) at screening and Day -1.
5. Adequate complete blood counts (complete blood counts \[CBCs\]; if outside the reference range, CBC values that are not clinically relevant and are acceptable to the Investigator)
6. Female subjects are eligible to participate if they are confirmed either not women of child-bearing potential (WOCBP), or have a negative urine pregnancy test at Day 1, are not breastfeeding, and willing and able to abide by the contraception guidelines.
7. Male subjects who can produce viable sperm are eligible to participate if they agree to use an adequate method of contraception as per the contraceptive guidance from Screening (signing the ICF) until at least 3 months post dose. Subjects with a partner(s) who is (are) not of childbearing potential are exempt from these requirements.
8. Male subjects with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration. In addition, male subjects must refrain from donating sperm from Screening (signing the ICF) until at least 3 months post dose.
9. Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent
Exclusion Criteria:
1. Male and female subjects, aged 18 to 60 years, inclusive.
2. Body mass index between 18 and 32 kg/m2, inclusive, with body weight \> 45 kg for females and \>50 kg for males .
3. Serum LDL-C ≥100mg/dL (2.6 mmol/L) at screening and Day -1.
4. Fasting triglycerides \< 400 mg/dL (\<4.52 mmol/L) at screening and Day -1.
5. Adequate complete blood counts (complete blood counts \[CBCs\]; if outside the reference range, CBC values that are not clinically relevant and are acceptable to the Investigator).
6. Female subjects are eligible to participate if they are confirmed either not women of child-bearing potential (WOCBP), or have a negative urine pregnancy test at Day 1, are not breastfeeding, and willing and able to abide by the contraception guidelines (signing the ICF).
7. Male subjects who can produce viable sperm are eligible to participate if they agree to use an adequate method of contraception as per the contraceptive guidance in Appendix 3 from Screening (signing the ICF) until at least 3 months post dose. Subjects with a partner(s) who is (are) not of childbearing potential are exempt from these requirements.
8. Male subjects with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile penetration. In addition, male subjects must refrain from donating sperm from Screening (signing the ICF) until at least 3 months post dose.
9. Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05905068
Study Brief:
Protocol Section:
NCT05905068