A PHASE 1, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL IN HEALTHY VOLUNTEERS TO DETERMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ESCALATING SINGLE AND MULTIPLE DOSES OF SNDX-6352 OR PLACEBO ADMINISTERED BY INTRAVENOUS (I.V.) INFUSION

A PHASE 1, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL IN HEALTHY VOLUNTEERS TO DETERMINE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ESCALATING SINGLE AND MULTIPLE DOSES OF SNDX-6352 OR PLACEBO ADMINISTERED BY INTRAVENOUS (I.V.) INFUSION - SNDX-6352-0001 SAD and MAD study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42865

Enrollment

Registered

2016-10-20

Start date

2016-10-20

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced cancer

Interventions

For part 1: The volunteer will receive SNDX-6352 or placebo once as an intravenous (iv) infusion of 30 minutes. The amount of study drug given to volunteer will differ per study group as follows: Gr

RANDOMIZED

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Healthy males or females, 18-55 years old, inclusive, at screening. Body Mass Index (BMI): 19.0-30.0 kg/m2, inclusive. Weight: 50-100 kg, inclusive.

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, or HIV/AIDS. In case of participation in another drug study 60 days before the start of this study or being a blood donor within 60 days from the start of the study. Donation or loss of more than 1.5 liters of blood (for male subjects) / more than 1.0 liters of blood (for female subjects) in the 10 months prior to (the first) drug administration in the current study.

Design outcomes

Primary

Measure	Time frame
Safety: Adverse events (AEs), clinical laboratory, vital signs, 12-lead electrocardiogram (ECG), presence of anti-drug antibodies (ADA) in plasma, eye examination, physical examination.	—

Secondary

Measure	Time frame
Pharmacokinetics: Plasma SNDX-6352 concentrations and receptor occupancy (RO). Plasma PK parameters Pharmacodynamics: Change in plasma CSF-1, IL-34, and CD-16 monocytes.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)