Safety and Pharmacokinetics of SNX-001 in Healthy Aged Volunteers

S

SeneXta Therapeutics SA

Status and phase

Completed
Phase 1

Conditions

Safety

Treatments

Drug: Placebo
Drug: SNX-001

Study type

Interventional

Funder types

Industry

Identifiers

NCT01269476
SNX-001-PH1-09
2009-011335-13 (EudraCT Number)

Details and patient eligibility

About

This is a randomised, double-blind, group-sequential, placebo-controlled, safety and pharmacokinetic study in healthy, aged volunteers. Objectives: 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 to establish SNX-001 pharmacokinetic profile.

Full description

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.

Enrollment

27 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

27 participants in 2 patient groups, including a placebo group

SNX-001
Experimental group
Treatment:
Drug: SNX-001
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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