Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers

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Status and phase: Completed; Phase 1

Conditions: Safety Issues

Treatments: Drug: ADX-914; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04485481

ADX-914-001

Details and patient eligibility

About

A two (2) part study to evaluate the safety, tolerability and PK of ADX-914

Full description

Part 1 - SAD:

It is expected that there will be up to 6 cohorts of 8 participants per cohort. In each cohort, participants will be randomly assigned in a 3:1 ratio to receive either ADX-914 or matching placebo.

It is planned that for each cohort in Part 1 a staggered 'sentinel' dose design will be used.

Part 2 - MAD It is expected that there will be up to 3 cohorts of 8 participants per cohort. In each cohort, participants will be randomly assigned in a 3:1 ratio to receive either ADX-914 or matching placebo. Doses will occur every 2 weeks, for a total of 4 doses.

Enrollment: 42 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, laboratory tests and ECG recording
• Men and women age 18-50

Exclusion criteria

• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin levels greater than 1.5 x the upper limit of normal (ULN) at Screening or Day -1.
• QT-interval measurements corrected according to the Fridericia rule (QTcF >450 msec) during controlled rest at Screening or family history of long QT syndrome.
• Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, in the judgment of the Investigator, may interfere with the interpretation of QTc-interval changes, including abnormal ST-T-wave morphology or left ventricular hypertrophy.
• A clinically significant vital signs abnormality, as judged by the Investigator, at Screening, or Day -1. This includes, but is not limited to, the following, in the supine position: (a) systolic blood pressure <90 or >140 mmHg, (b) diastolic blood pressure <40 or >90 mmHg, or (c) heart rate <40 or >100 beats per minute.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 4 patient groups, including a placebo group

Experimental: Cohort 1:1 - 1:6 ADX-914

Experimental group

Description:

ADX-914 single SC dose

Treatment:

Drug: ADX-914

Drug: ADX-914

Placebo Comparator: Cohort 1:1 - 1:6 placebo

Placebo Comparator group

Description:

Placebo single SC dose

Treatment:

Drug: Placebo

Drug: Placebo

Experimental: Cohort 2:1- 2:3

Experimental group

Description:

ADX-914 multiple SC dose once every 2 weeks for 6 weeks

Treatment:

Drug: ADX-914

Drug: ADX-914

Placebo Comparator: Cohort 2:1- 2:3

Placebo Comparator group

Description:

Placebo multiple SC dose once every 2 weeks for 6 weeks

Treatment:

Drug: Placebo

Drug: Placebo