A Phase 1 Study of ABBV-CLS-7262, Rosuvastatin, and Digoxin in Healthy Subjects

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study follows an open-label, single arm design with two periods with rosuvastatin, digoxin and ABBV-CLS-7262

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Calico Life Sciences LLC
• Collaborator: AbbVie

Criteria

Inclusion Criteria:

• Adult volunteers in general good health

• Must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures

• Individuals between 18 and 65 years of age inclusive at the time of screening

• BMI is ≥ 18.0 to ≤ 32.0 kg/m2

• All male subjects who are sexually active and not surgically sterilized must agree to use an acceptable contraceptive method. Additionally, male subjects must agree to not donate sperm during the study until 30 days after the final dose of study drug

• All female subjects who are sexually active and of childbearing potential must agree to use a highly effective contraceptive method. Additionally, female subjects must agree to not donate eggs during the study and for 30 days after the final dose of study drug.

Exclusion Criteria:

• Subject who, in the opinion of the investigator, is incapable of completing study-required visits and procedures

• Pregnant or breastfeeding.

• Treatment with any other investigational treatment within 30 days