A First in Human Study evaluating the Safety, Tolerability and Pharmacokinetics of ABBV-CLS-628 in Healthy Volunteers

Phase 1

Active, not recruiting

• Conditions: Kidney Disease; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12622001550796
• Lead Sponsor: Calico Life Sciences LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-15
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 138

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified