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Drug & research development » Clinical trials » NCT01339897

A Safety Study Evaluating N6022 in Multiple-Ascending Doses in Healthy Subjects

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of N6022 in Healthy Subjects

Clinical Trials gov number: NCT01339897

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Purpose: To evaluate multiple doses across a range that has been found to be effective in mouse models of asthma, and safe in one Phase 1 clinical trial. It is intended to provide evidence of the tolerability of multiple doses as well as provide information on the pharmacokinetic (PK) and metabolism of N6022 in humans.

Phase: 1

Type: Interventional, randomized, double-blind, parallel assignment

Study sponsor: Nivalis Therapeutics, Inc.

  • Subject is healthy, determined by pre-study medical evaluation (medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations)
  • Non-smoker (or other nicotine user) as determined by history (no nicotine use over the past year) and a negative urine cotinine test at screening and Day 1
  • Body weight >50 kg and BMI between 19.5 and 29.5 kg/m2, inclusive, at screening
  • Subject has systolic BP >90 mmHg and diastolic BP >50 mmHg at screening or Day-1

Intervention
N6022

Geographical Location
United States

Number of Participants
≤50 (18-45 years)

Primary Endpoint

Safety of escalating multiple doses of N6022 in healthy subjects (7 days)

Secondary Endpoint

Pharmacokinetics of N602 (Day 1 and Day 7 – 24 hours)

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  • Active Comparator: 5 mg/N6022 injectable formulation, given at doses per cohort of 5 mg given QD each day over 7 days
  • Placebo Comparator: Placebo injectable formulation normal saline
  • Active Comparator: 10mg/N6022 injectable formulation, given at doses of 10 mg given QD each day over 7 days
  • Active Comparator: 20mg/N6022 injectable formulation, given at doses per cohort of 20 mg given QD each day over 7 days
View Trial Results