A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics of DZD8586 in Healthy Adult Participants

Overseen By Lisa Diamond

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Dizal (Jiangsu) Pharmaceutical Co., Ltd.

Must not be taking: Prescription drugs, Nonprescription drugs

Disqualifiers: Hepatitis, HIV, Malignancy, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

64 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop using any prescription medications 28 days before the study drug is given, unless the investigator approves them. Non-prescription medications, including vitamins and herbal products, should be stopped 14 days before the study drug, unless approved by the investigator.

What is the purpose of this trial?

This trial is testing a new drug in healthy adults. It will help identify possible side effects and measure how the drug behaves in the body.

Research Team

Frank Lee

Principal Investigator

Frontage Clinical Services, Inc.

Eligibility Criteria

Inclusion Criteria

Body mass index (BMI) 18~30 kg/m2. Bodyweight of ≥ 45 kg (Female) or ≥ 55 kg (Male).

Participants must be able to understand the nature of the trial and provide a signed and dated, written informed consent form before any study-specific procedures, sampling, and analyses.

Non-smoker (never smoked or > 1 year from the last occurrence of smoking).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of DZD8586 or placebo to assess safety, tolerability, and pharmacokinetics

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• DZD8586
• Placebo

Participant Groups

Group I: Single dose of DZD8586 Experimental Treatment 1 Intervention

Single dose of DZD8586

Group II: Single dose of Placebo Placebo Group 1 Intervention

Single dose of Placebo

Who Is Running the Clinical Trial?

Dizal (Jiangsu) Pharmaceutical Co., Ltd.

Lead Sponsor

Trials

4

Recruited

290+