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

AnnJi Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: ALZ002 DS

Study type: Interventional

Funder types: Industry

Identifiers

NCT04392830

ALZ002-101

Details and patient eligibility

About

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

Enrollment: 72 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

ALZ002 DS

Experimental group

Description:

SAD: 6 cohorts of subjects are planned to be orally dosed, ranging from 15 mg - 800 mg. MAD: 3 cohorts of subjects are planned to be orally dosed once or twice daily for 7 consecutive days, ranging from 300 mg - 600 mg.

Treatment:

Drug: ALZ002 DS

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo