A Study to Evaluate Single Doses of Alpha-0261 in Healthy Adult Volunteers

AlphaMol Science Ltd. (Shanghai)

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: Placebo; Drug: Alpha-0261

Study type: Interventional

Funder types: Industry

Identifiers

NCT07279636

Alpha-0261-001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Alpha-0261 tablets after single oral administration in healthy adult volunteers.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged ≥ 18 and ≤ 55, male or female
• Weight: ≥ 50 kg for males, ≥ 45 kg for females; 19 kg/m2 ≤ body mass index (BMI) ≤ 28 kg/m2
• In general good health

Exclusion criteria

• Have a history of any severe allergic reaction or anaphylaxis
• Any condition, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol
• Have clinically significant abnormalities on clinical laboratory results

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Single Ascending Dose

Experimental group

Treatment:

Drug: Alpha-0261

Single Ascending Dose (placebo)

Placebo Comparator group

Treatment:

Other: Placebo