None listed
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled, phase 1 first-in-human study to evaluate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of ABBV-CLS-628 in healthy adult volunteers
Interventions
Three parts:
Part A: Multiple Cohorts, Single Ascending Dose
Part B: Multiple Cohorts, Multiple Ascending Dose, dose TBD based on the safety data from Part A by a safety review committee
Part C: Multiple Cohorts of Asian Healthy Volunteers, Single Ascending Dose, dose TBD based on the safety data from Part A by a safety review committee.
Each Part will involve unique participant cohorts
Mode of Administration – subcutaneous (SC) injection or intravenous (IV) infusion. Participa
Three parts: Part A: Multiple Cohorts, Single Ascending Dose Part B: Multiple Cohorts, Multiple Ascending Dose, dose TBD based on the safety data from Part A by a safety review committee Part C: Multiple Cohorts of Asian Healthy Volunteers, Single Ascending Dose, dose TBD based on the safety data from Part A by a safety review committee. Each Part will involve unique participant cohorts Mode of Administration – subcutaneous (SC) injection or intravenous (IV) infusion. Participants must fast overnight for at least 8 hours for pre-dose safety labs prior to each dose. All interventions will be administered only in the Phase 1 unit, and adherence will be monitored by supervised administration by site staff. Part A: approximately 59 participants Cohort 1: ABBV-CLS-628 single dose on Day 1 – 30mg IV infusion Cohort 2: ABBV-CLS-628 single dose on Day 1 – up to 100mg IV infusion Cohort 3: ABBV-CLS-628 single dose on Day 1 – up to 100mg SC injection Cohort 4: ABBV-CLS-628 single dose on Day 1 – up to 300mg IV infusion Cohort 5: ABBV-CLS-628 single dose on Day 1 – up to 300mg SC injection Cohort 6: ABBV-CLS-628 single dose on Day 1 – up to 900mg IV infusion Cohort 6b: ABBV-CLS-628 single dose on Day 1 - Optional mg SC injection Each Part A Cohort will include 2 sentinel participants (1 ABBV-CLS-628, 1 placebo) who will be dosed first prior to dosing the rest of the Cohort. Part B: approximately 42 participants Cohort 7: ABBV-CLS-628 by SC injection every two weeks for up to four doses – Dose TBD based on Part A Cohort 8: ABBV-CLS-628 by SC injection every two weeks for up to four doses – Dose TBD based on Part A Cohort 9: ABBV-CLS-628 by IV infusion every two weeks for up to four doses – Dose TBD based on Part A Part C: approximately 34 participants Cohort 10: ABBV-CLS-628 single dose on Day 1 by SC injection: Dose TBD based on Parts A&B Cohort 11: ABBV-CLS-628 single dose on Day 1 by IV infusion: Dose TBD based on Parts A&B Cohort 12a: ABBV-CLS-628 single dose on Day 1 by SC injection: Dose TBD based on Parts A&B Cohort 12b: ABBV-CLS-628 single dose on Day 1 by IV injection: Dose TBD based on Parts A&B Part A: Cohorts 1, 2, 4 and 6 have 8 participants; Cohorts 3, 5 and 6b will have 9 participants Part B: Cohorts 7-8 will have 12 participants; Cohort 9 will have 18 participants Part C: Cohorts 10-12a will have 8 participants and Cohort 12b will have 10 participants
Sponsors
Calico Life Sciences LLC
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy volunteers between 18 and 65 years of age, inclusive at the time of screening 2. Body Mass Index (BMI) is greater than or equal to 18.0 kg/m2and less than or equal to 32.0 kg/m2; minimal weight is greater than or equal to 45kg 3. Women must be of non-childbearing potential 4. In the opinion of the investigator, this participant is a suitable candidate for enrollment in the study 5. Parts A and B, have no ethnicity requirements. 6. Part C only, volunteers must be: Chinese cohorts: Participant must be first- or second-generation Han Chinese of full Chinese, Taiwanese or Hong Kong parentage residing outside of China for less than10 years. Participants must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet. Japanese cohorts: Participant must be first- or second-generation Japanese of full Japanese parentage residing outside of Japan for less than 10 years. Participants must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet. Recruitment with first or second generation Han Chinese and Japanese participants is prioritized for Part C.
Exclusion criteria
1. Is currently enrolled in another clinical study. 2. Has previously received ABBV-CLS-628. 3. Participants who have been treated with any investigational drug within 30 days prior to the first dose of study drug. 4. Participants who require any non-prescription and/or prescription medication, vitamins and/or herbal supplements on a regular basis. 5. Participants who use any medications, vitamins and/or herbal supplements within the 2-week period prior to study drug administration. 6. Receipt of any drug by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study drug administration.
Outcome results
None listed