Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001550796
Ethics application status
Approved
Date submitted
19/11/2022
Date registered
15/12/2022
Date last updated
9/05/2024
Date data sharing statement initially provided
15/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A First in Human Study evaluating the Safety, Tolerability and Pharmacokinetics of ABBV-CLS-628 in Healthy Volunteers
Scientific title
A Randomized, Double-blind, Placebo-controlled, Phase 1 First-in-Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABBV-CLS-628 in Healthy Adult Volunteers
Secondary ID [1] 308433 0
M23-892
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Disease 328240 0
Condition category
Condition code
Renal and Urogenital 325282 325282 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 324880 0
Treatment: Drugs
Comparator / control treatment
Saline Placebo - subcutaneous (SC) injection or an intravenous (IV) infusion administered similarly to that of ABBV-CLS-628 for the given cohort
Control group
Placebo

Outcomes
Primary outcome [1] 333334 0
To evaluate the safety and tolerability of escalating single and multiple doses of ABBV-CLS-628 following single and multiple IV infusions or SC injections



Adverse events will be assessed and documented in accordance with the NIH DAIDS grading scale. Possible AEs:



Decreases in the blood cells responsible for carrying oxygen from the lungs to other parts of the body and for protecting the body from infection will be assessed by standard blood chemistry.

Increase in a substance in the blood that helps it to form clots will be assessed by standard blood chemistry.

Pain, redness or swelling around the point of injection will be assessed by visual inspection.
Timepoint [1] 333334 0
Part A:

Blood samples collected at pre-dose, and post-dose on days 2, 4, 8, 15, 22, 29, 43, 57 and 85.



Physical exam performed at pre-dose and post-dose on days 1, 2, 8 and 85.



ECG collected at pre-dose, and post-dose 0, 12, 24, 48 hours and on days 4, 5, 6, 7, 8, 22, 43 and 85.



AEs collected at pre-dose and post-dose on days 1-8, 15, 22, 29, 43, 57, 85 and 106.



Part B:



Blood samples collected at pre-dose, on dosing days 1, 15, 29, and 43. Also collected post-dose on days 2, 4, 8, 14, 22, 28, 42, 58, 72, 86 and 128.



Physical exam performed at pre-dose on day 1, and post-dose on days 1, 2, 42, 100 and 128.



ECG collected at pre-dose and post-dose day 1 on hours 2, 4, 12, 24, and 48. On dosing days 15, 29, and 43, ECG collection will occur pre-dose and post-dose on hours 2 and 4. Additional ECG collection will occur post-dose on days 4, 8, 50, 65, 86 and 128.



AEs collected at pre-dose, and post-dose on days 1-4, 8, 14, 22, 28, 36, 42, 50, 58, 65, 72, 86, 100, 128, and 149.



Part C:

Blood samples collected at pre-dose, and post-dose on days 2, 4, 8, 15, 22, 29, 43, 57 and 85.



Physical exam performed at pre-dose and post-dose on days 2, 8, 43 and 85.



ECG collected at pre-dose, and post-dose on hours 0, 2, 12, 24, 48 post-dose and on days 4, 6, 8, 15, 22, 29, 43, 57 and 85.



AEs collected at pre-dose, and post-dose on days 1- 4, 8, 15, 22, 29, 43, 57, 85 and 106.
Secondary outcome [1] 415933 0
Parts A&C: Pharmacokinetic parameters in blood from healthy volunteers (HV) following single dose of ABBV-CLS-628. Parameters assessed will include but are not limited to maximum observed serum concentration (Cmax), the time to Cmax (Tmax), the area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt), AUC from time 0 to infinity (AUCinf), terminal phase elimination rate constant (ß), terminal phase elimination half-life (t1/2) etc. as available data allow.



Part B: Pharmacokinetic parameters in blood from HVs following multiple doses of ABBV-CLS-628. Parameters assessed as defined from Parts A and C.


Timepoint [1] 415933 0
Part A:

Blood samples collected at pre-dose, and post-dose on hours 0, 0.5, 2, 4, 12, 24 and 48 and on days 4, 6, 8, 15, 22, 29, 43, 57 and 85 post-dose.




Part B:

Blood samples collected at pre-dose, and post-dose day 1 on hours 0.5, 2, 4, 8, 12, 24 and 48. Additional blood samples on dosing days 15, 29, and 43 occur pre-dose and post-dose on hours 0.5, 2, and 4. Additional blood samples post-dose on days 4, 8, 50, 58, 65, 72, 86, 100, and 128.



Part C:

Blood samples collected at pre-dose, and post-dose on hours 0, 0.5, 2, 4, 12, 24, and 48 hours, and on days 4, 6, 8, 15, 22, 29, 43, 57 and 85.
Secondary outcome [2] 415934 0
Prevalence of Anti-drug Antibodies (ADA) as measured in blood serum for ABBV-CLS-628 at baseline and incidence of ADA during the study.
Timepoint [2] 415934 0
Part A

Blood samples collected pre-dose, and post-dose on days 15, 29, 43, 57, and 85.



Part B

Blood samples collected pre-dose, and post-dose on days 15, 29, 43, 58, 86, 100 and 128.


Part C

Blood samples collected pre-dose, and post-dose on days 15, 29, 43, 57, and 85.
Secondary outcome [3] 415935 0
Pharmacodynamics of ABBV-CLS-628 by measuring blood, urine and hair for exploratory biomarkers
Timepoint [3] 415935 0
Part A

Blood samples collected at pre-dose, and post-dose on hours 4, 12, 24 and 48 and on days 4, 8, 15, 22, 29, 43, and 85



Urine Samples collected at pre-dose, and post-dose on hours 24 and on days 4, 8, 29, and 85



Hair samples collected at pre-dose, and post-dose on hours 48 and on day 8





Part B

Blood samples collected at pre-dose and post-first dose on hours 4, 12, 24 and 48. Additional blood samples collected at pre-dose on dosing days 15, 29, and 43. Additional blood sample collected post-dose on days 4, 8, 58, 86, 100 and 128 days



Urine Samples collected at pre-dose, and at post-first dose on hours 24. Additional urine samples collected at pre-dose on dosing days 15, 29, and 43. Additional urine samples collected post-dose on days 4, 8, 86 and 128.



Hair samples collected at pre-dose on days 1 and 15, and at post-dose on days 8, 50 and 58.



Part C (only blood)

Blood samples collected at pre-dose, and at post-dose on hours 4, 12, 24 and 48. Also post-dose on days 4, 8, 15, 22, 29, 43, and 85.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
30/04/2023
Actual
3/05/2023
Date of last participant enrolment
Anticipated
Actual
14/02/2024
Date of last data collection
Anticipated
11/07/2024
Actual
Sample size
Target
135
Accrual to date
Final
138
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 312681 0
Commercial sector/Industry
Name [1] 312681 0
Calico Life Sciences LLC
Country [1] 312681 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Calico Life Sciences LLC
Address
1170 Veterans Blvd
South San Francisco, CA 94080
Country
United States of America
Secondary sponsor category [1] 314291 0
Commercial sector/Industry
Name [1] 314291 0
IQVIA RDS Pty. Limited
Address [1] 314291 0
Level 8, 201 Pacific Highway
St Leonards, Sydney
NSW 2065
Country [1] 314291 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311983 0
Alfred Health Human Research Ethics Committee
Ethics committee address [1] 311983 0
Ethics committee country [1] 311983 0
Australia
Date submitted for ethics approval [1] 311983 0
05/12/2022
Approval date [1] 311983 0
03/02/2023
Ethics approval number [1] 311983 0
8/23 (HREC/92175Alfred-2023)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123058 0
Dr Sam Francis
Address 123058 0
Nucleus Network
Level 5 Burnet Tower, 89 Commercial Road, Melbourne, Victoria 3004
Country 123058 0
Australia
Phone 123058 0
+61 466 640 801
Fax 123058 0
Email 123058 0
[email protected]
Contact person for public queries
Name 123059 0
Nucleus Network Melbourne
Address 123059 0
Nucleus Network
Level 5 Burnet Tower, 89 Commercial Road, Melbourne, Victoria 3004
Country 123059 0
Australia
Phone 123059 0
+61 03 8593 9800
Fax 123059 0
Email 123059 0
[email protected]
Contact person for scientific queries
Name 123060 0
Greg van Wyk
Address 123060 0
IQVIA
Level 8, 201 Pacific Highway
St. Leonards, NSW
Australia, 2065
Country 123060 0
Australia
Phone 123060 0
+61 0298 056 800
Fax 123060 0
Email 123060 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study is for supporting compound development only.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.