Safety and Pharmacokinetics of SNX-001 in Healthy Aged Volunteers

SeneXta Therapeutics SA27 enrolled

Overview

This is a randomised, double-blind, group-sequential, placebo-controlled, safety and pharmacokinetic study in healthy, aged volunteers. Objectives: 1. to confirm the previously reported safety profile of oral SNX-001 after single and multiple doses of 3.6, 7.2 or 10.8 mg compared to placebo 2. to establish SNX-001 pharmacokinetic profile.

This study is an exploratory study designed as a group sequential single and multiple escalating dose, double-blind within cohort, randomized, placebo controlled study to investigate the safety and tolerability as well as the pharmacokinetics and pharmacodynamics of SNX-001 given as oral doses in aged volunteers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Safety

Interventions

SNX-001DRUG

3.6, 7.2, or 10.8 mg single dose or t.i.w.

PlaceboDRUG

Same volumes and frequency as active.

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy males or females * Physically and mentally healthy subjects * Body weight \>60 kg and body weight ≤ 100 kg Exclusion Criteria: * Evidence of any clinically significant hepatic, renal, gastrointestinal, cardiovascular, pulmonary, haematological, psychiatric, neurological or other significant acute or chronic abnormalities * History of general malignant diseases * Evidence of myasthenic weakness * Acute infection or any other febrile illness

Locations (1)

Scope Life Sciences GmbH

Hamburg, Germany

Outcomes

Primary Outcomes

Relationship of clinical safety measurements to dose

Adverse events (AEs), vital signs, electrocardiogram (ECG), Acetylcholinesterase (AChE) inhibition, laboratory parameters after single and multiple dose administration

Time frame: Throughout 14-day study period (Days 1, 2, 3, 10, 12, 13, 14) and 7 days after last dose (Day 21)

Secondary Outcomes

Effect of dose on pharmacokinetic (PK) parameters

Pharmacokinetic parameters after single and multiple dose administration of SNX-001 (3.6, 7.2 and 10.8 mg)

Time frame: After single (Day 1) and multiple (Day 12) doses

Data from ClinicalTrials.gov

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