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

A Randomized, Double-blind, Placebo-Controlled, Dose-Escalation, Phase Ia Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Oral Administration of Alpha-0261 Tablets in Adult Healthy Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07279636

Enrollment

Registered

2025-12-12

Start date

2025-07-21

Completion date

2026-04-15

Last updated

2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

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.

Interventions

DRUGAlpha-0261

Oral, tablet

OTHERPlacebo

Oral, tablet

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Frequency of treatment emergent adverse events	From enrollment to end of follow-up visit, up to approximately 1 week

Secondary

Measure	Time frame	Description
Plasma PK of Alpha-0261 after single dose	From enrollment to end of treatment period, up to approximately 7 days	Maximum Plasma Concentration (Cmax)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026