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Completed

NCT Number: NCT04392830

A Study to Investigate the Safety, Tolerability, Pharmacokinetics of ALZ002 DS in Healthy Volunteers

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of single-ascending and multiple-ascending doses of ALZ002 DS.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cmax clinical research

Adelaide, 5000, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and/or non-childbearing potential female subjects, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥18 and ≤55 years of age at screening.
  • Body mass index > 18.5 and < 30.0 kg/m2, and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females at screening visit.
  • Capable of consent.

Exclusion criteria

  • Any clinically significant abnormality or abnormal laboratory test results
  • Positive urine drug screen, alcohol breath test, or urine cotinine test
  • History of significant allergic reactions to any drug.
  • Participation in a clinical research study involving the administration of an investigational or marketed drug or device
  • History of clinically significant opportunistic infection
  • Presence of fever (body temperature > 38°C)

Treatment and study plan

ALZ002 DS

Drug

Administered orally

Other names: JM17

Placebo

Drug

Administered orally

Primary outcomes

  1. Incidence of SAEs and treatment-related adverse events

    Time frame: Baseline through Study Completion (up to Day 14)

    Incidence of SAEs and treatment-related severe AEs

Secondary outcomes

  1. Maximum Plasma Concentration (Cmax) will be assessed

    Time frame: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose; Day 3: predose; Day 4:predose; Day 5:predose; Day 6: predose; Day7: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose

    Maximum observed plasma concentration (Cmax)

  2. Area Under the Curve (AUC) will be assessed

    Time frame: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose; Day 3: predose; Day 4:predose; Day 5:predose; Day 6: predose; Day7: predose, 0.5, 1, 2, 4, 8, 12, 16, and 24 hours postdose

    Area under the plasma concentration versus time curve

Sponsors and collaborators

Lead sponsor

AnnJi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study, to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses (SAD-MAD) of ALZ002 DS in Healthy Volunteers

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 19, 2020
Registry last updated
Aug 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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